EXPERRT Act of 2012

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. Rare Disease Congressional Caucus. Provisions contained in S. 3187/H.R. 5651 (which became Public Law 112-144), the Food and Drug Administration Safety and Innovation Act, relating to the drug approval process and including the Best Pharmaceuticals for Children and Pediatric Research Equity Acts; S. 606/H.R. 3059, the Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; and H.R. 4156/S. 2281, Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012. H.R. 6163/S. 3461, the National Pediatric Research Network Act of 2012.

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Client expense: $4,140,000 · Firm income: Not reported

S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. Rare Disease Congressional Caucus. Provisions contained in S. 3187/H.R. 5651 (which became Public Law 112-144), the Food and Drug Administration Safety and Innovation Act, relating to the drug approval process and including the Best Pharmaceuticals for Children and Pediatric Research Equity Acts; S. 606/H.R. 3059, the Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; and H.R. 4156/S. 2281, Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to raising awareness of Hepatitis C (no specific bills); Viral Hepatitis Testing Act of 2011 (H.R. 3381, S. 1809), all provisions; Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 (H.R. 2405, S. 1855), all provisions; (cont'd next page) Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 (H.R.4156 , S.2281), all provisions; Transforming the Regulatory Environment to Accelerate Access to Treatments (S.2113), provisions; The Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R.3737), all provisions; The Food and Drug Administration Safety and Innovation Act (S.3187), all provisions; To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies (H.R.5334), all provisions; The FAST Act (H.R.4132), all provisions; The Food and Drug Administration Reform Act of 2012 (H.R.5651), all provisions.

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. Rare Disease Congressional Caucus. Provisions contained in S. 3187/H.R. 5651 (which became Public Law 112-144), the Food and Drug Administration Safety and Innovation Act, relating to the drug approval process and including the Best Pharmaceuticals for Children and Pediatric Research Equity Acts; S. 606/H.R. 3059, the Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; and H.R. 4156/S. 2281, Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues related to neuromuscular disease, including transitional health care issues. S. 3187/H.R. 5651 (P.L. 112-144), Food and Drug Administration Safety and Innovation Act and provisions incorporated - including S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; S. 606/H.R. 3059, Creating Hope Act; and H.R. 4156/S. 2281, Expanding & Promoting Expertise in Review of Rare Treatments Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

S.606/H.R. 3059 - Creating Hope Act of 2011 Prescription Drug User Fee Act Reauthorization S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act H.R. 1483, Drug Safety Enhancement Act H.R. 3737, ULTRA (Unlocking Lifesaving Treatments for Rare Diseases) Act H.R. 4132, FAST (Faster Access to Specialized Treatments) Act Amendments to FDA Accelerated Approval Requirements H.R. 4156, EXPERRT (Expanding and Promoting Expertise in Review of Rare Treatments) Act H.R. 2182, GAIN (Generating Antibiotic Incentives Now) Act S. 1734, Generating Antibiotic Incentives Now Act Biosimilars User Fees Biosimilars Exclusivity Period in Administration's Budget Proposals

Client expense: $360,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

House, Senate, FDA, Energy and Commerce and Labor-HHS Committee on Prescription Drug User Fee Act Agreement (PDUFA V), HR 4156, and S 2218; funding for National Center for Advancing Translational Sciences (NCATS) at NIH, FDA funding, NIH funding; FY13 Appropriations and Sequestration; CMS/Medicaid; Congressional CF Caucus; Patient Protection and Affordable Care Act and general health reform issues; Teen Advocacy Day and May Board on the Hill lobby days

Client expense: $180,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Food and Drug Administration Safety and Innovation Act, including provisions of the Expanding and Promoting Exertise in Review of Rare Treatments Act of 2012 (S. 2281/HR 4156) as incorporated in the Act

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.606/H.R. 3059 - Creating Hope Act of 2011 Prescription Drug User Fee Act Reauthorization S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act H.R. 1483, Drug Safety Enhancement Act H.R. 3737, ULTRA (Unlocking Lifesaving Treatments for Rare Diseases) Act H.R. 4132, FAST (Faster Access to Specialized Treatments) Act Amendments to FDA Accelerated Approval Requirements H.R. 4156, EXPERRT (Expanding and Promoting Expertise in Review of Rare Treatments) Act H.R. 2182, GAIN (Generating Antibiotic Incentives Now) Act S. 1734, Generating Antibiotic Incentives Now Act Biosimilars User Fees Biosimilars Exclusivity Period in Administration's Budget Proposals

Client expense: $375,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to raising awareness of Hepatitis C (no specific bills); Viral Hepatitis Testing Act of 2011 (H.R. 3381, S. 1809), all provisions; Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 (H.R. 2405, S. 1855), all provisions; (cont'd next page) Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 (H.R.4156 , S.2281), all provisions; Transforming the Regulatory Environment to Accelerate Access to Treatments (S.2113), provisions; The Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R.3737), all provisions; Issues related to the 2012 Prescription Drug User Fee Act Reauthorization Discussion Draft, all provisions

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

House, Senate, FDA on EXPERRT Act (HR 4156, S 2218), Energy and Commerce and Labor-HHS Committee on Prescription Drug User Fee Act Agreement (PDUFA V), funding for National Center for Advancing Translational Sciences (NCATS) at NIH, FDA funding, NIH funding, Appropriations testimony, FTC on MedCo ExpressScripts merger, CMS on Medicare and Medicaid, Congressional CF Caucus, HHS comments on health reform and other regulations, FDA on Kalydeco

Client expense: $130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA)

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

Legislation reauthorizing the Prescription Drug User Fee Act S.2281/HR 4156, Expanding and Promoting Expertise in Review of Rare Treatments Act

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE