GAO Report: FDA Struggles to Track Safety of Expedited Drugs

The Government Accountability Office (GAO) has found that the Food and Drug Administration (FDA) lacks reliable, readily accessible date on tracked safety issues and postmarket studies needed to meet postmarket safety reporting requirements and conduct systematic oversight of drugs approved through expedited pathways. From October 2006 through the end of 2014, the FDA granted 525 fast-track requests. But the agency struggles to track the safety of these drugs once they are on the market, according to the report. These problems have prevented the FDA from publishing statutorily required reports on potential safety issues and postmarket studies in a timely manner. GAO recommends that the FDA develop plans that comprehensively outline how to correct the problems with postmarket safety data.

Upcoming Congressional Meetings and Hearings

Senate Special Aging Committee: Field Hearing - Fighting Against a Growing Epidemic: Reducing the Misuse and Abuse of Opioids in America; 9:45 a.m., Governor’s Office Building, 200 Madison Street, Jefferson City, MO 65101 Ballroom; January 19

House Minority Whip Steny Hoyer, D-Md., hosts a roundtable discussion on the Affordable Care Act’s “current open enrollment period, availability of financial assistance, and outreach efforts to encourage Prince George’s County residents to sign up for affordable health coverage in 2016 before the January 31 deadline;” 1:30 p.m., 800 J Shoppers Way, Largo, Md.; January 19

Senate Health, Education, Labor and Pensions Committee: hearing titled “Improving the Federal Response to Challenges in Mental Health Care in America;” 10:00 a.m., 430 Dirksen Bldg.; January 20

Senate Finance Committee: hearing titled “CO-OPs: A Review of the Financial and Oversight Controls;” 9:30 a.m., 219 Dirksen Bldg.; January 21

House Veterans’ Affairs Health Subcommittee: hearing on “Choice Consolidation: Evaluating Eligibility Requirements for Care in the Community;” 10:00 a.m.,334 Cannon Bldg.; February 2

House Veterans’ Affairs Health Subcommittee: hearing on “Choice Consolidation: Improving VA Community Care Billing and Reimbursement;” 10:00 a.m., 334 Cannon Bldg.; February 11

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