MARK LENKER

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 -PDUFA Reauthorization

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

Medicaid rare disease patient access to therapy; Medicaid line extension rebates; Expanded access - H.R. 909, the Andrea Sloan Compassionate Use Reform and Enhancement Act; Patent Reform - H.R. 9, Innovation Act; S. 632, STRONG Patents Act; Rare Pediatric Disease Priority Review Vouchers - H.R. 1537, Advancing Hope Act of 2015; DEA processes and re-exportation; FDA funding; Orphan Drug Tax Credit; Newborn Screening; Binge Eating Disorder awareness; ADHD awareness; Rare diseases awareness; FDA policies regarding wound care healing

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, S. 1878, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers; H.R. 2515, S. 1865, Anna Westin Act of 2015; S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports; H.R. 971, S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1767, Combination Product Regulatory Fairness Act of 2015; S. 2041, Promoting Life-Saving New Therapies for Neonates Act of 2015

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, S. 1878, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers; H.R. 2515, S. 1865, Anna Westin Act of 2015; S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports; H.R. 971, S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1767, Combination Product Regulatory Fairness Act of 2015; S. 2041, Promoting Life-Saving New Therapies for Neonates Act of 2015

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, S. 1878, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers; H.R. 2515, S. 1865, Anna Westin Act of 2015; S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports; H.R. 971, S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1767, Combination Product Regulatory Fairness Act of 2015; S. 2041, Promoting Life-Saving New Therapies for Neonates Act of 2015

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

Medicaid rare disease patient access to therapy; Medicaid line extension rebates; Expanded access - H.R. 909, the Andrea Sloan Compassionate Use Reform and Enhancement Act; Patent Reform - H.R. 9, Innovation Act; S. 632, STRONG Patents Act; Rare Pediatric Disease Priority Review Vouchers - H.R. 1537, Advancing Hope Act of 2015; DEA processes and re-exportation; FDA funding; Orphan Drug Tax Credit; Newborn Screening; Binge Eating Disorder awareness; ADHD awareness; Rare diseases awareness; FDA policies regarding wound care healing

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, S. 1878, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers; H.R. 2515, S. 1865, Anna Westin Act of 2015; S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports; H.R. 971, S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1767, Combination Product Regulatory Fairness Act of 2015; S. 2041, Promoting Life-Saving New Therapies for Neonates Act of 2015