Drug Safety and Accountability Act of 2010

H.R. 4173, the Wall Street Reform and Consumer Protection Act of 2009 - Lobbied in favor of financial regulatory reforms, including consumer and investor protections, a potential systemic risk regulator, and consolidation of agencies. H.R. 5809, the Safe Drug Disposal Act of 2010 -Would amend the Controlled Substances Act to provide for the take back and safe disposal of controlled substances. The bill provides for an educational effort about proper drug disposal, an EPA report on the same and a GAO report on the effectiveness of disposal programs. S. 3690, the Drug Safety and Accountability Act of 2010 - Requires drug manufacturers to implement quality management plans and document the manufacturing supply chain to ensure the quality and safety of drugs. The bill also would expand FDA authority to recall unsafe drugs, including over the counter drugs, and offers protection to whistle blowers. Restoring American Financial Stability Act of 2010 - Lobbied for support of the bill and to preserve consumer and investor protections, preserve states authority to enforce consumer protection laws and CFPA's authority to enforce rules it adopts. (no bill)

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of and implementation of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of and implementation of health care law which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act. S. 3606, Agriculture, Rural Development, FDA and related agencies Appropriations Act, FY 2011 - Lobbied for increased funding for the FDA Office of Generic Drugs to reduction of application backlog. H.R. 3081, H.R. 3082, H.J.Res. 105, H.J.Res.101, Continuing Resolution, FY 2011 - Lobbied for funding for FDA Office of Generic Drugs and nutrition assistance. S.3690, the Drug Safety and Accountability Act of 2010 - Requires drug manufacturers to implement quality management plans and document the manufacturing supply chain to ensure the quality and safety of drugs. The bill also would expand FDA authority to recall unsafe drugs, uncluding over the counter drugs, and offers protection to whistle blowers. H.R.5809,would amend the Controlled Substances Act to provide for the take back and safe disposal of controlled substances. The bill provides for an educational effort about proper drug disposal, an EPA report on the same and a GAO report on the effectiveness of disposal programs.

H.R. 4173, the Wall Street Reform and Consumer Protection Act of 2009 - Lobbied in favor of financial regulatory reforms, including consumer and investor protections, a potential systemic risk regulator, and consolidation of agencies. H.R. 5809, the Safe Drug Disposal Act of 2010 -Would amend the Controlled Substances Act to provide for the take back and safe disposal of controlled substances. The bill provides for an educational effort about proper drug disposal, an EPA report on the same and a GAO report on the effectiveness of disposal programs. S. 3690, the Drug Safety and Accountability Act of 2010 - Requires drug manufacturers to implement quality management plans and document the manufacturing supply chain to ensure the quality and safety of drugs. The bill also would expand FDA authority to recall unsafe drugs, including over the counter drugs, and offers protection to whistle blowers. Restoring American Financial Stability Act of 2010 - Lobbied for support of the bill and to preserve consumer and investor protections, preserve states authority to enforce consumer protection laws and CFPA's authority to enforce rules it adopts. (no bill)

Client expense: $9,120,000 · Firm income: Not reported

S.369/HR 1706, Preserve Acess to Affordable Generics; HR 759, FDA Globalization Act; S.3690, Drug Safety & Accountability Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care; Implementation of P.L. 111-152, Health Care & Education Reconciliation; S.3677, the Financial Services & General Government Appropriations Act; HR3082, Continuing Appropriations & Surface Transportation Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.369/HR 1706, Preserve Acess to Affordable Generics; HR 759, FDA Globalization Act; S.3690, Drug Safety & Accountability Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care; Implementation of P.L. 111-152, Health Care & Education Reconciliation; S.3677, the Financial Services & General Government Appropriations Act; HR3082, Continuing Appropriations & Surface Transportation Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 759, HR 5740, S 882, S 3690 - regarding the manufacturing and importation of OTC drugs and the mandatory recall authority of the FDA.

Client expense: $715,571 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of

S. 3690 Drug Safety and Accountability Act of 2010, provisions related to provising the Food and Drug Administration with adequate resources to ensure safety of drugs imported to the US from foreign manufacturers.

Client expense: $75,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

Labor-Health and Human Services Appropriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010, all provisions. H.R.6543, Drug Safety Enhancement Act of 2011. Contacts concerning Food and Drug Administration authority to manage drug shortages. Contacts concerning funding for section 3503 of H.R. 3590, Patient Protection and Affordable Care Act.

Client expense: $250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

American Recovery and Reinvestment Act (P.L. 111-5); Patient Protection and Affordable Care Act (H.R. 3590); Reconciliation Act of 2010 (H.R. 4872); Prescription Drug User Fee Act (PDUFA) reauthorization (no introduced bill yet); Drug Safety and Accountabiity Act of 2010 (S. 3690); Food and Drug Globalization Act (H.R. 759)

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - S. 3690, "Drug Quality and Safety Enhancement Act", regarding comments related to standards-setting for drugs and verification programs. - Comments on medication errors with respect to docket # FDA-2010-N-0168. - Communications in support of FDA funding.

Client expense: $60,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 369/H.R. 1706, Preserve Access to Affordable Generics; H.R. 759, FDA Globalization Act; S. 3690, Drug Safety and Accountability Act; Implementation of P.L. 111-148, Patient Protection and Affordable Care; Implementation of P.L. 111-152, Health Care and Education Reconciliation

Client expense: Not reported · Firm income: $160,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 369/H.R. 1706, Preserve Access to Affordable Generics; H.R. 759, FDA Globalization Act; S. 3690, Drug Safety and Accountability Act; Implementation of P.L. 111-148, Patient Protection and Affordable Care; Implementation of P.L. 111-152, Health Care and Education Reconciliation

Client expense: Not reported · Firm income: $160,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to methamphetamine precursor chemicals HR 759, HR 5740, S 882, S 3690 - regarding the manufacturing and importation of OTC drugs and the mandatory recall authority of the FDA.

Client expense: $736,734 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Office of Natl Drug Control Policy (NDCP), SENATE

HR 4816, the Food and Drug Administration Improvement Act of 2010, provisions related to providing the Food and Drug Administration with resources to ensure safety of drugs imported into the US from foreign countries. S. 3690 Drug Safety and Accountability Act of 2010, provisions related to provising the Food and Drug Administration with adequate resources to ensure safety of drugs imported to the US from foreign manufacturers.

Client expense: $79,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Pedigree - Regulatory Impact of Healthcare Legislation - Patient Protection and Affordable Care Act, HR 3590 - S.3690 Drug Safety and Accountability Act

Client expense: $1,323,877 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Customs & Border Protection

American Recovery and Reinvestment Act (P.L. 111-5); Patient Protection and Affordable Care Act (H.R. 3590); Reconciliation Act of 2010 (H.R. 4872); Prescription Drug User Fee Act (PDUFA) reauthorization (no introduced bill yet); Drug Safety and Accountabiity Act of 2010 (S. 3690); Food adn Drug Globalization Act (H.R. 759)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor-Health and Human Services Apprpriations fiscal years 2010 and 2011. S. 3690, Drug Safety and Accountability Act of 2010 all provisions. Communication with FDA on the judicious use of medically important antimicrobial drugs in food-producing animals, and the Safe Use Initiative. Communications to Agency for Healthcare Research and Quality regarding comparative effectiveness.

Client expense: $250,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE