Medical Device User Fee Stabilization Act of 2005

S. 16: A bill to reduce to the cost of quality health care coverage and improve the availability of health care coverage for all Americans. Lobbied to protect the interests of the Biotech drug industry. S. 109, H.R. 328: A bill entitled the "Pharmaceutical Market Access Act of 2005". Lobbied for an exemption for biologics.S.184,H.R. 753: A bill to amend the Federal Food, Drug, and Cosmetic Act to protect the public health from the unsafe importation of prescription drugs and from counterfeit prescription drugs, and for other purposes. Lobbied for an exemption for biologics. S. 334, H.R. 700: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. Lobbied for an exemption for biologics. H.R. 563: To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate and disclose lowest possible prices for prescription drug prices for Medicare beneficiaries, and with respect to the Federal Food, Drug, and Cosmetic Act, to provide waivers that permit such beneficiaries to import prescription drugs from Canada. Lobbied for an exemption for biologics. H.R. 578: To amend the Internal Revenue Code of 1986 with respect to the purchase of prescription drugs by individuals who have attained retirement age, and to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and the sale of such drugs through Internet sites. Lobbied for an exemption for biologics. H.R.1626: To amend part D of the title XVIII of the Social Security Act to authorize the Secretary of Health and Human Services to negptiate for lower prices for Medicare prescription drugs and to eliminate the gap in coverage of Medicare prescrition durg benefits, to the Secretary of Health and Human Services to promulgate regulations for the reimportation of prescription drugs, and for other purposes. Lobbied for an exemption for biologics. H.R. 2599: To improve the quality, availability, diversity, personal privacy, and innovation of health care in the United States. Lobbied for an exemption for biologics.. H.R.16: To authorize the use of Federal funds for research on human embryonic stem cells irrrespective of the date on which such stem cells were derived, and for other purposes. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 596, S. 681: To amend the Public Health Service Act to establish a National Cord Blood Stem Cell Bank Network to prepare, store, and distribute human umbilical cord blood stem cells for the treatment of patients and to support peer-reviewed research using such cells. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 810, S. 471: To amend the Public Health Service Act to provide for human embryonic stem cell research. H.R.1650: To amend the Internal Revenue Code of 1986 to allow tax credits to holders of stem cell research bonds. Lobbied to prevent the unreasonable restriciton of legitimate medical research or clinical trials. H.R. 1822, S. 876: To prohibit human cloning and protect stem cells research. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 2541: To amend the Public Health Service Act to provide for the expansion, intensification, and coordination of the activities of the National Institutes of Health regarding qualifying adult stem cell research, and for other purposes. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R.2520, S.1317: To provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and research, and to amend the Public Health Service Act to authorize the C.W. Bill Young Cell Transplantation Program. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 2574: To amend the Public Health Service Act to provide for a program at the National Institutes of Health to conduct and support research on animals to develop techniques for the derivation of stem cells from embryos that do not harm the embryos, and for other purposes. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. S.1392: A bill to reauthorize the Federal Trade Commission. (Dorgan/Snowe Drug Importation Amendment). Lobbied for an exemption for biologics. H.R.3144: To amend the Public Health Service Act to provide for a program at the National Institutes of Health to conduct and support research in the derivation and use of human pluripotent stem cells by means that do not harm human embryos, and for other purposes. Lobbied for the interests of the vaccine industry. H.R.3423,S.1420: To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees. Lobbied for the interests of the medical device industry. S.226: A bill to amend the Public Health Service Act to improve immunization rates by increasing the supply of vaccines. Lobbied for the interst of the vaccine industry. S.521,H.R.1290: A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, research, and medical management referral program for hepatitis C virus infection. Supported bill. S.969,H.R.3369: A bill to amend the Public Health Service Act with respect to preparation for an influenza pandemic, including an avian influenza pandemic, and for other purposes. Lobbied for the interests of the vaccine industry. S.1422,H.R.881: A bill to amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through vaccines. Lobbied for the interests of the vaccine industry. H.R.650: To establish reasonable legal reforms that will facilitate the manufacture of vital, life-saving vaccines, and for other purposes. Lobbied for the interests of the vaccine industry. H.R.1297: To amend the Public Health Service Act with respect to the National Vaccine Injury Compensation Program. Lobbied for the interests of the vaccine industry. S.930: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. Lobbied to prevent the unreasonable restricition of legitimate medical research or clinical trials. S.470: A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. Lobbied to provide the best information to the patient. H.R.2090: To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. Lobbied for provisions that promoted the development safe and effective drugs. H.R.2124,H.R.2308: To amend the Public Health Service Act to provide for clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, and for other purposes. Lobbied for reasonable provisions that support research and clinical trials. H.R.2650: To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to protect consumers in managed care plans and other health coverage. Lobbied for the interests of the industry. H.R.2792: To permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests, and for other purposes. Lobbied for the interests of the industry. H.R.3196,H.R.2259,S.1012: To amend the Public Health Service Act to expand the scope of information required for the data bank on clinical trials of drugs, and for other purposes. Lobbied for reasonable provisions that support research and clinical trials. S.1128: A bill to amend title XIX of the Social Security Act to provide for increased rebates under the medicaid program for prescription drugs that are directly advertised to consumers, to require other Federal programs purchasing or reimbursing for such drugs to establish payment and reimbursement mechanisms that reduce the costs of those drugs, and for other purposes. Lobbied to ensure that any enacted restrictions would not impede access of the consumer to accurate information about pharmaceutical products. H.R.840,S.399: A bill to amend the Federal Food, Drug and Cosmetic Act with respect to the sale of prescription drugs through the internet, and for other purposes. Lobbied to ensure that the internet would not be used to import counterfeit and defective medical products. H.R.1808,S.334: To amend the Federal Food, Drug, and Cosmetic Act to create a uniform certification standard for Internet pharmacies and to prohibit Internet pharmacies from engaging in certain advertising activities, to prohibit the use of certain bank instruments for purchases associated with illegal Internet pharmacies, and for other purposes. Lobbied to ensure that the internet would not be used to import counterfeit and defective medical products. H.R.4395: To amend titles XVIII and XIX of the Social Security Act to provide for an improved voluntary Medicare prescription drug benefit, to provide greater access to affordable pharmaceuticals, and for other purposes. Lobbied for an exemption for biologics in the Drug Importation section. S.470: A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. S.930: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. Lobbied to prevent the unreasonable restricition of legitimate medical research or clinical trials. S.1873: A bill to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R.2345: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. Lobbied in support of enhanced FDA authorities over counterfeit products. H.R.3052,S.1527: Vaccine Access and Supply Act, lobbied for provisions to strengthen the domestic vaccine industry. H.R.3970: Bioterror and Pandemic Preparedness Protection Act, lobbied in support of provisions to assure domestic pandemic preparedness. S.1821: Pandemic Preparedness and Response Act, lobbied in support of provisions to assure domestic pandemic preparedness. S.1828: Influenza Vaccine Security Act of 2005, lobbied in support of provisions to assure as strong domestic vaccine industry. S.1912: Global Network for Avian Influenza Surveillance Act, lobbied in support of domestic pandemic preparedness. S.375: Flu Protection Act of 2005, lobbied in support of domestic influenza provisions to stabilize production and supply. S.969: Attacking Viral Influenza Across Nations Act of 2005, lobbied in support of influenza provisions. General matters related to vaccine industry stability, pandemic preparedness, avian influenza.

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

S.1420, Medical Device User Stabilization Fee Act of 2005 2005 Budget Reconciliation

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

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

H.R.3423/S.1420-Medical Device User Fee Stabilization Act of 2005. (Bills related to user fees for medical devices.) H.R. 2090-Food and Drug Administration Improvement Act of 2005 (Bill related to FDA Advisory panels.) H.R.3196/S.470-Fair Access to Clinical Trials (FACT) Act (Bills to expand the scope of information required for the data bank on clinical trials.) S.3-Protecting America in the War on Terror Act of 2005 - Biopreparedness Act of 2005. (Bill sets provisions concerning bioterrorism preparedness and defense as pertaining to medical devices.) S.975-The Project Bioshield II Act of 2005. (Bill to provide incentives to increase research by private sector entities to develop medical countermeasures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak.) H.R.5-Help, Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2005. (Bill to provide improved medical care by reducing excessive burden the liability system places on the health care delivery system.) S.295-To authorize appropriate action if the negotiations with the People's Republic of Chhina's undervalued currency are not successful. (Bill to impose an additional duty of 27.5% on Chinese imports.) H.R.3004-Currency Harmonization Initiative through Neutralizing Action Act of 2005. (Bill to impose additional tariffs on Chinese imports on the basis of the rate of manipulation by that country of the rate of exchange between the Chinese currency and the U.S. dollar.) H.R.3045/S.1307-Dominican Republic-Central American-United States Free Trade Agreement Implementation Act. (Bills implementing the Central American-Dominican Republic Free Trade Agreenment (CAFTA-DR) into law.) H.R.3283/S.1421-United States Trade Rights Amendments Act (Bill to enhance resources to enforce U.S. trade rights.) S.950-Elimination of Neglected Diseases Act of 2005. (Bill to provide assistance to combat turburculosis, malaria and other infecitous diseases.) S.1223-Information Technology for Health Care Quality and Improvement Act. S.1355-Better Healthcare Through Information Technoogy. (Bills to enhance the adoption of health information technology and to improve the quality and reduce the costs of health care in the United States.) S.1262-Health Technology to Enhance Quality Act of 2005. S.1418-Wired for Health Care Quality Act (Bills to reduce healthcare costs, improve efficiency and healthcare quality through development of a nation-wide interoperable health information technology system.) S.978-Healthcare Tax Relief for the Uninsured Act of 2005. H.R.1872-Health Coverage for the Uninsured Act of 2005. (Bills to provide tax incentives for the purchase of quality health care, and for other purposes.)

Client expense: $2,460,000 · 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), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)