House Members ask FDA for Changes to Generic Drug Labeling Rule

In a letter sent to the FDA, House Oversight and Government Reform Committee Chairman Darrell Issa (R-CA) and other committee Republicans criticized the Food and Drug Administration’s (FDA) proposed ruling which would allow generic drug manufacturers to independently update product labeling with newly acquired safety information before the FDA’s review of the change (in the same manner as for manufacturers of brand name drugs). They asked for further information on the process and communications involved in the process, stating “Given the intent of the rule is to create an environment for increased litigation, the Committee finds it troubling that the FDA consulted only with trial lawyers, but no other major stakeholder likely to be affected….”

House E&C Subcommittee Oversight of CDC Anthrax Scare

The House Energy and Commerce Oversight and Investigations Subcommittee grilled Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC) about the agency’s lapses in safely handling anthrax and other deadly viruses. Chairman Tim Murphy (R-PA) said the potential exposure of CDC personnel to the deadly anthrax toxin, as well as the contamination of influenza strains with a deadly flu virus, was inexcusable. The CDC Director said the lapses were “unacceptable”, that the cause was due to “an insufficient culture of safety” and that he will convene a high-level working group within the agency and an external advisory group of outside experts to help establish safety protocols.

Upcoming Health-Related Hearings and Markups

House Energy and Commerce Health Subcommittee: will hold a hearing titled “21st Century Cures: Examining Barriers to Ongoing Evidence Development and Communication;” 3:00 p.m., 2123 Rayburn Bldg; July 22.

Senate HELP Committee: will hold an executive session to consider health and income security bills, including S. 315, Paul D. Wellstone Muscular Dystrophy Community Assistance, Research, and Education (MD-CARE) Amendments of 2013, S. 2154, Emergency Medical Services for Children Reauthorization Act of 2014, S. 2405, Trauma Systems and Regionalization of Emergency Care Reauthorization Act; S. 2406, Improving Trauma Care Act of 2014, and S. 2539, Traumatic Brain Injury Reauthorization Act of 2014; 10:00 a.m., 430 Dirksen Bldg; July 23.

House Energy and Commerce Health Subcommittee: will hold a roundtable discussion on “the rise of personalized medicine and advances on science and technology;” 10:00 a.m., 2123 Rayburn Bldg; July 23.

House Ways and Means Oversight Subcommittee: will hold a hearing on the health care overhaul law’s premium tax credit; 10:30 a.m., 1100 Longworth Bldg; July 23.

House Ways and Means Health Subcommittee: will hold a hearing on the status of Medicare Advantage under the health care law; 10:00 a.m., 1100 Longworth Bldg; July 24.

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