A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety.

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Client expense: $2,480,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---National Biodefense Strategy Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Drug Product Communications ---H.R. 1703: The Medical Products Communications Act of 2017 ---S. 2157: Drug-Price Transparency in Communications Act ---Direct to Consumer Advertising Disclosures ------H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Client expense: $2,520,000 · Firm income: Not reported

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) ---S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) Biosimilars ---Access to Samples for Testing ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---S. 974/H.R. 2212: CREATES Act of 2017 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6142/S. 2042: Reducing Drug Waste Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018' H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2312: HELP Act - Provisions related to 340B program S. 2406: ACE Research Act - Research initiatives of the NIH S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Opioids shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)