FDA Needs Broad Reforms, Says Government Watchdog--January 2009


The General Accounting Office has added FDA's regulation and oversight of medical products to its biennial list of high-risk areas needing special attention by the new Congress.

The FDA’s oversight of medical products is among 3 new areas of government considered “high risk” by the General Accounting Office (GAO) in its 2009 report to Congress. GAO produces this report every 2 years to alert legislators to those functions of government especially in need of broad-based reform.

GAO’s finding follows on the many concerns raised about the FDA’s ability to ensure the safety and efficacy of drugs, biologics, and medical devices. GAO’s report notes that, “the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products.” The FDA’s foreign drug inspection program, its review processes for manufacturers’ promotional materials, and its monitoring of compliance with regulations on the presentation of clinical trial results are among the areas GAO identified as needing particular attention.

In addition to the FDA oversight, GAO added 2 other activities to its list of 27 high-risk areas for 2009: modernizing the outdated US financial regulatory system and transforming the Environmental Protection Agency’s processes for assessing and controlling toxic chemicals.

A new acting FDA commissioner was named on January 20—Frank M. Torti, MD, MPH, FACP. Dr. Torti has served as principal deputy commissioner and chief scientist at the FDA since May 2008.

For other articles in this issue, see:

Clinical Pharmacists Worth the Investment

Pharmacy Groups Endorse HR 616

Stimulus Plan Likely to Include Health IT

FDA Issues Strong Warning on Topical Anesthetics

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