FDA Delays Final Generic Drug Labeling Regs

The Food and Drug Administration (FDA) announced that it is delaying until September 30, 2015 the publication of final regulations establishing the agency’s generic drug labeling rule. The proposed rule generated a deluge of comments that the agency said it is considering. In related news, Senator Bernard Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced bills that would require generic drug companies to reimburse Medicaid if they raise the prices of their drugs more quickly than inflation. At a Senate HELP subcommittee hearing, Senator Richard Burr (R-NC) and Elizabeth Warren (D-MA) sparred on why the prices of some generic drugs have recently increased significantly. Sen. Warren relied on reported statistics to support her argument that the FDA has not imposed a significant burden on generic drug manufacturers.

Health Related Legislation Recently Introduced

S. 2930 (VETERANS’ HEALTH), to direct the secretary of Defense and the secretary of Veterans Affairs to provide for the conduct of an evaluation of mental health care and suicide-prevention programs of the Department of Defense and the Department of Veterans Affairs, to require a pilot program on loan repayment for psychiatrists who agree to serve in the Veterans Health Administration of the Department of Veterans Affairs, and for other purposes; MCCAIN; to the Committee on Veterans’ Affairs, Nov. 17.

H.R. 5723 (MEDICAID), to amend Title XIX of the Social Security Act to extend the application of the Medicare payment rate floor to primary care services furnished under Medicaid and to apply the rate floor to additional providers of primary care services; CASTOR of Florida; to the Committee on Energy and Commerce, Nov. 17.

H.R. 5724 (NATIONAL INSTITUTES OF HEALTH), to amend the Public Health Service Act to provide funding for the National Institutes of Health; CASTOR of Florida; jointly, to the committees on Energy and Commerce, the Budget and Appropriations, Nov. 17.

H.R. 5725 (INSURANCE REGULATION), to amend the Internal Revenue Code of 1986 to repeal the individual health insurance mandate; JOLLY; to the Committee on Ways and Means, Nov. 17.

H.R. 5729 (TROPICAL DISEASES), to expand the program of priority review to encourage treatments for tropical diseases; BLACKBURN; to the Committee on Energy and Commerce, Nov. 18.

H.R. 5732 (MEDICARE), to amend Title XVIII of the Social Security Act to crack down on fraud in Medicare to protect seniors, people with disabilities and taxpayers; DEUTCH; jointly, to the committees on Energy and Commerce and Ways and Means, Nov. 18.

S. 2942 (INFECTIOUS DISEASES), to establish a hospital fund for the treatment of individuals with Ebola or other specified infectious diseases; MARKEY; to the Committee on Health, Education, Labor and Pensions, Nov. 19.

H.R. 5740 (VETERANS’ HEALTH), to amend Title 38, U.S. Code, to increase the maximum age for children eligible for medical care under the CHAMPVA program; FORTENBERRY; to the Committee on Veterans’ Affairs, Nov. 19.

S. 2948 (MEDICAID), to extend the requirement that drug manufacturers that increase prices faster than inflation pay an additional rebate to state Medicaid programs to include manufacturers of generic drugs; SANDERS; to the Committee on Finance, Nov. 20.

S. 2950 (VETERANS’ HEALTH), to amend Title 38, U.S. Code, to establish the Physician Ambassadors Helping Veterans program to seek to employ physicians at the Department of Veterans Affairs on a without compensation basis in practice areas and specialties with staffing shortages and long appointment waiting times; MORAN; to the Committee on Veterans’ Affairs, Nov. 20.

S. 2953 (EBOLA VIRUS OUTBREAK), to prohibit an alien who is a national of a country with a widespread Ebola virus outbreak from obtaining a visa and for other purposes; RUBIO; to the Committee on the Judiciary, Nov. 20.

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