Verifying Authority and Legality In Drug Compounding Act of 2012

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

Client expense: $4,400,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 1919 - Safeguarding America's Pharmaceuticals Act; provisions related to supply chain security H.R. 6584 - Verifying Authority and Legality in Drug Compounding Act; provisions relating to drug compounding H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accountsS. 957 - Drug Supply Chain Security Act; provisions related to supply chain security S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking FDA accelerated approval policy issues Comparative effectiveness policy issues Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues 340B prescription drug policy issues FDA special medical use; issues related to limited population antibacterial drug approval pathway

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

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

Client expense: $5,270,000 · Firm income: Not reported

H.R.1316, Stop Oxy Abuse Act of 2011: To limit the approval of any drug containing controlled-release oxycodone hydrochloride H.R. 1513, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing H.R. 2674, 340B Program Improvement Act: Provisions related to 340B 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. 4209, Patients Access to Treatments Act: To limit cost-sharing requirements applicable to prescription drugs in a specialty drug tier 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. 6288, Patient Choice Act: To permit provisional approval of fast track products H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding H.R. 6611, Patient Access to Drugs in Shortage Act of 2012: Promote public notification and provide incentives to reduce drug shortages 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. 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 Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Vaccine-related policy issues Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - HR 6584, Verifying Authority and Legality In Drug Compounding Act of 2012, regarding all provisions.

Verifying Authority and Legality in Drug (VALID) Compounding Act (H.R. 6584), provisions related to pharmacy operations

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 27 - legislation that would authorize the Federal Trade Commission to presume illegal agreements between manufacturers of innovator and generic pharmaceutical products in which the generic manufacturer agrees to delay entry into the market in exchange for compensation from the manufacturer of the innovator product; HR 2746 - legislation that would require cost-sharing parity between all cancer medication within pharmacy benefits regulated under ERISA; HR 979 - legislation that would implement transparency standards and other regulations for pharmacy benefit managers working within the Federal Employees Health Benefits Program; HR 4209 - legislation that would require individual and group health insurance policies covered under ERISA and which use a formulary for prescription drug coverage to charge the same co-payments/co-insurance rate for specialty drugs as the co-payments/co-insurance rate for non-preferred brand drugs; HR 1971/S 1058 - legislation that would impose transparency and audit requirements for PBMs contracting with group health plans; HR 6584 - legislation that would impose federal requirements on compounding pharmacies

Client expense: $170,000 · Firm income: Not reported

FY 2014 Budget, FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 H.R.6584 - Verifying Authority and Legality In Drug Compounding Act of 2012 H.R.6611 - Patient Access to Drugs in Shortage Act of 2012 H.R.6638 - S.A.F.E. Compounded Drugs Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $486,262 · Firm income: Not reported

H.R.1873/S.987 (Arbitration Fairness Act); to prohibit mandatory binding arbitration in consumer contracts. H.R.6351 (Fairness in Nursing Home Arbitration Act); relating to the use of arbitration agreements to resolve disputes involving nursing home care and nursing home contracts. Lobbying with regard to the enforceability of mandatory, pre-disdpute arbitration provisions in employment and consumer contracts, including financial consumer contracts. S.1946/H.R.3646 (Foreign Manufacturers Legal Accountability Act); to require foreign manufacturers of products imported into the United States to establish registered agents in the United States who are authorized to accept service of process against such manufacturers, and for other purposes. Lobbying with regard to the preemption of state causes of action involving medical device and drug manufacturers. S.3076/H.R.4369 (Furthering Asbestos Claim Transparency Act); to amend title 11 of the United States Code to require the public disclosure by trusts established under section 524(g) of such title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos, and the filing of such reports with the Executive Office for United States Trustees. S.2295/H.R.4384 (Patient Safety and Generic Labeling Improvement Act); to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand name drug manufactuers to do so. H.R.6065 (no short title); to make improvements to the Children's Gasoline Burn Prevention Act; specific interest in provisions to limit the liability of gasoline container manufacturers. H.R. 6584 (Verifying Authority and Legality In Drug Compounding Act of 2012), to amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products; specific interest in preservation of state-based causes of action. General lobbying with regard to the regulation of compoudning pharmacies and preservation of state-based causes of action. S.1223 (Location Privacy Protection Act of 2012); to address voluntary location tracking of electronic communications devices; specific interest in creation of enforcement actions and Grassley Amendment (failed in Committee) to require transparency for outside counsel retained by State Attorneys General.

H.R. 2182/S. 1734 - Generating Antibiotic Incentives Now Act . Supporting work to increase innovation and development of new antibiotics. S. 1584 - Drug Safety and Accountability Act- Supporting legislation and related Congressional activity regarding upstream supply stream safety. H.R. 3026- Safeguarding America's Pharmaceuticals Act. Supporting legislation and congressional activity regarding downstream supply chain safety. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. Policies related to the growing concerns regarding drug shortage issues in hospitals across the country. Potential language related to Track and Trace provisions regarding downstream supply chain safety being considered by the Senate HELP and House Energy and Commerce Committees. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.

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

H.R. 2182/S.1734 - The Generating Antibiotic Incentives Now Act. Supporting work to increase innovation in the development of new antibiotics. S. 1584 - The Drug Safety and Accountability Act. Supporting upstream supply chain safety issues. S. 3026 - Safeguarding America's Pharmaceuticals Act Supporting downstream supply chain issues. Implementation and rulemaking related to the Physician Payment Sunshine Act - A Medicare-related provision in the Health Reform Law focused on increasing systemic transparency. S. 3295- The Department of Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2013. Supporting report language clarifying congressional intent for the funding of the Physician Payment Sunshine Act. Improvement of safety and efficacy of medical devices. Work related to treatment of medical devices in the upcoming FDA user fee arena. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.

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

H.R. 6413, support for the "Transitional Care Act of 2012." Contact concerning Food and Drug Administration (FDA) authority to manage drug shortages. Communication to FDA on approval of biosimilars and drug safety. Communications to Health Resources and Services Administration on 340B drug discount program. Communication with FDA and Centers for Disease Control and Prevention on compounding.Provided input on H.R. 6584, "Verifying Authority and Legality In Drug Compounding Act of 2012."

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.

Client expense: Not reported · Firm income: $6,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.

Client expense: Not reported · Firm income: $11,810

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA reform and legislation related to dietary supplements. S. 216, Food Safety Accountability Act of 2011, to increase criminal penalties for certain knowing and intentional violations relating to food that is misbranded or adulterated. Monitor development of regulations by the FDA that overly restrict the dietary supplement industry. Support language in Agriculture Appropriations Act (H.R. 5973) to restrict scope of FDA regulations concerning dietary supplements. H.R. 1364, Free Speech About Science Act of 2011. Legislation to allow growers of healthy foods and manufacturers of dietary supplements to cite legitimate scientific studies on the health benefits of these products without having them classified as unapproved new drugs. S. 1098/H.R. 2010, the Family Retirement and Health Investment Act, increasing limits of and making improvements to Health Savings Accounts, and allowing for dietary supplements to be included as qualified medical costs. Monitor development of regulations by the FDA that overly restrict the dietary supplement industry. No specific legislation yet. Oppose legislation to amend the Controlled Substances Act to prevent the alleged abuse of dehydroepiandrosterone. FDA authority and regulation of dietary supplements, specifically with regards to a current DOD initiative/review of products containing DMAA. No legislation is applicable or expected. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.

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