ULTRA

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Client expense: $110,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), 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

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Client expense: $110,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R. 3737); Faster Access to Specialized Treatments (H.R. 4132); Food and Drug Administration Safety and Innovation Act (S. 3187); Food and Drug Administration Reform Act of 2012 (H.R. 5661)]

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

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: $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. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. NO BILL, Reauthorization of the Prescription Drug User Fee Act - Lobbied for passage of clean PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

Client expense: $820,000 · Firm income: Not reported

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

Client expense: $660,000 · Firm income: Not reported

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. NO BILL, Reauthorization of the Prescription Drug User Fee Act - Lobbied for passage of clean PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

Client expense: $820,000 · Firm income: Not reported

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Client expense: $100,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), 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

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. NO BILL, Reauthorization of the Prescription Drug User Fee Act - Lobbied for passage of clean PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

Client expense: $860,000 · Firm income: Not reported

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

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R. 3737); Faster Access to Specialized Treatments (H.R. 4132) -- all provisions; ]

Client expense: Not reported · Firm income: $15,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug User Fee (PDUFA) Reauthorization Pharmaceutical Supply Chain issues TREAT Act (S. 2113); FAST Act (H.R. 4132); ULTRA Act (H.R. 3737)

Client expense: $105,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Implementation of Affordable Care Act -Essential Health Benefits -Comparative Effectiveness Research HR 3497: MODDERN Cures Act Prescription Drug User Fee Act Medical Device User Fee Act S 2113: TREAT Act HR 3737: ULTRA Act

Client expense: $25,547 · 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

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R. 3737) -- all provisions]

Client expense: Not reported · Firm income: $15,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 296, Preserving Access to Life Saving Medicines Act; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); Life Sciences Investment Act Issues relating to R&D funding for rare disease products, biosimilars and other products; end stage renal disease (ESRD) orphan drugs; reimbursements; drug shortages; DEA quotas; prescription drug user fees; exclusivity periods

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prepare advocacy materials to be used for lobbying on issues related to development of drugs for rare diseases, reimbursement of products, and FDA review and approval of products for rare diseases and other conditions. Prepared materials regarding S. 296, Preserving Access to Life Saving Medicines Act; Met with congressional staff regarding same shortage legislation. Developed advocacy materials re: HR 3737 "Unlocking Live Saving Rare Diseases Act.

Client expense: Not reported · Firm income: $40,000

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE