POLICY BRIEFINGS


FDA Issues


FDA User Fee Reauthorization Passes House E&C Committee
The House Energy and Commerce Committee voted unanimously to pass H.R. 5651, legislation to reauthorize Food and Drug Administration user fee legislation for medical devices and drugs.  The reauthorization would extend the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA).  The bill would also authorize new user fee programs: the Generic Drug User Fee Act (GDUFA) and the Biosimilars User Fee Act (BSUFA).  The bill would require the FDA to meet certain performance goals, fostering more interaction, predictability and certainty between industry and the FDA.  A similar Senate HELP Committee bill is expected to be taken up in the Senate this month.  Chairman Upton said his intent is to have the bill passed in the House this month and for a final conference agreement to be enacted by July 4th.

Senate Finance Investigates Growing Painkiller Prescription Abuse Senators Max Baucus and Charles Grassley sent letters to the Federation of State Medical Boards, major drug companies and academic experts requesting records documenting financial and other ties within the drug industry as part of a Senate Finance Committee investigation into whether drug companies might be contributing to the “epidemic of accidental deaths and addiction [to prescription painkillers] by promoting misleading information about the drugs’ safety and effectiveness….”  The senators said their intent is to ensure that physicians and patients receive accurate information about the risks and benefits of the drugs that is not affected by financial interests.


Recently Introduced Health Legislation


S. 2516 (USER FEES), to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; HARKIN; from the Committee on Health, Education, Labor, and Pensions; placed on the calendar, May 7.

S. 2620 (MEDICARE), to amend Title XVIII of the Social Security Act to provide for an extension of the Medicare-dependent hospital (MDH) program and increased payments under the Medicare low-volume hospital program; SCHUMER; to the Committee on Finance, May 7.

H.R. 5334 (MEDICAL THERAPIES), to amend Chapter V of the Federal Food, Drug, and Cosmetic Act to expedite development and review of breakthrough therapies; BILBRAY; to the Committee on Energy and Commerce, May 7.

H.R. 5341 (MEDICAL DEVICES), to improve postmarket risk identification and analysis with respect to devices, and for other purposes; CAPPS; to the Committee on Energy and Commerce, May 7.

H.R. 5357 (DRUGS), to suspend temporarily the duty on placebos to be used in clinical trials for the drug ASP2408; DOLD; to the Committee on Ways and Means, May 7.

H.R. 5358 (DRUGS), to suspend 1temporarily the duty on placebos to be used in clinical trials for the drug ASP0777; DOLD; to the Committee on Ways and Means, May 7.

H.R. 5364 (DRUGS), to suspend temporarily the duty on placebos to be used in clinical trials for the drug ASKP1240; DOLD; to the Committee on Ways and Means, May 7.

H.R. 5566 (MEDICAID), amend Title XIX of the Social Security Act to increase the federal medical assistance percentage for the territories; CHRISTENSEN; to the Committee on Energy and Commerce, May 8.

H.R. 5624 (MEDICARE/PUBLIC HEALTH), to amend Title XVIII of the Social Security Act to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under Medicare, to amend Title III of the Public Health Service Act to extend discounts under the 340B program, and for other purposes; MCMORRIS RODGERS; jointly, to the committees on Energy and Commerce and Ways and Means, May 8.

H.R. 5646 (ABORTION), to prohibit funds appropriated for the Department of Homeland Security from being used to pay for an abortion, and for other purposes; HUIZENGA of Michigan; jointly, to the committees on Energy and Commerce and the Judiciary, May 8.

H.R. 5647 (WOMEN’S HEALTH), to eliminate discrimination and promote women’s health and economic security by ensuring reasonable workplace accommodations for workers whose ability to perform the functions of a job are limited by pregnancy, childbirth, or a related medical condition; NADLER; jointly, to the committees on Education and the Workforce, House Administration, Oversight and Government Reform, and the Judiciary, May 8.

H. RES. 644 (NURSES), recognizing National Nurses Week May 6-12, 2012; EDDIE BERNICE JOHNSON
of Texas; to the Committee on Energy and Commerce, May 7.

H.R. 5650 (ABORTION), to amend Title X of the Public Health Service Act to provide for no discrimination under the family planning program under such title on the basis of separate provision of abortion; DOLD; to the Committee on Energy and Commerce, May 9.

H.R. 5651 (USER FEE PROGRAMS), to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; UPTON; to the Committee on Energy and Commerce, May 9.

H.R. 5690 (FIRST RESPONDERS), to amend the Public Health Service Act to authorize the secretary of health and human services to make grants to eligible entities to train elementary and secondary school nurses on how to respond to a biological or chemical attack or an outbreak of pandemic influenza in a school building or on school grounds; ISRAEL; to the Committee on Energy and Commerce, May 9.

H.R. 5707 (MEDICARE), to amend Part B of Title XVIII of the Social Security Act to reform Medicare payment for physicians’ services by eliminating the sustainable growth rate system and providing incentives for the adoption of innovative payment and delivery models to improve quality and efficiency; SCHWARTZ; jointly, to the committees on Energy and Commerce, Ways and Means, and the Budget, May 9. 



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