FEBRUARY 2009
Chronic underfunding, expanding mandates and rapidly evolving science jeopardize the Agency's ability to fulfill its mission
Since the start of the new year, evidence of the Food and Drug Administration's (FDA) inability to fulfill its mission of protecting public health has escalated, placing pressure on the Congress and the Obama administration to take immediate steps toward substantial reform of the Agency and the appointment of new leadership.
In early January, nine scientists at the FDA wrote to then President-elect Barack Obama and his transition team making a bold appeal for immediate intervention at the Agency to correct what they alleged to be widespread managerial misconduct, intimidation and corruption.
Adding strength to the scientists' call for reform was a report released by the Government Accountability Office (GAO), the investigative arm of Congress, on January 22. The report placed the FDA on its list of high-risk areas, questioning the FDA's ability to ensure the safety and efficacy of drugs, biologics and medical devices in addition to highlighting specific weaknesses.
"FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results," recommended the report. It also noted the expansion of FDA responsibilities and its struggle to keep pace with the enormous scientific and technological advances made in recent years, challenging new safety problems, and the globalization of industries that it is charged to regulate.
The GAO releases the At Risk Series at the beginning of each new session of Congress to help legislators develop priorities and form an oversight agenda. The report sheds light on government programs and operations that face significant challenges and warrant extra attention by Congress and the executive branch. The FDA was one of 30 government operations identified in the report as "at risk."
Related Items:
- With the change of administration, Dr. Andrew C. von Eschenbach officially stepped down as commissioner and was replaced by Dr. Frank M. Torti who will serve as acting commissioner until there is a permanent appointment to the post. Dr. Torti has a background as an accomplished clinician, scientist and researcher in molecular oncology and joined the FDA in 2008.
- FDA funding has lagged disproportionately behind appropriations for other public health agencies over the past 20 years.
Reports:
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