FDA's Power to Ensure Drug Safety Lacking After Approval

The Food and Drug Administration (FDA) faces criticism for its handling of drugs, with the flu vaccine crisis serving as a recent example. Despite its efforts to quickly approve new medicines, the agency's authority to monitor drug safety after market approval is shockingly weak. As a result, American consumers are increasingly exposed to the risk of dangerous side effects that did not appear in original clinical trials. The FDA relies heavily on voluntary reports from doctors, which only a small fraction of adverse outcomes, and the primary responsibility for collecting and evaluating postmarketing study data rests with manufacturers.

Key Takeaways:

• The FDA lacks sufficient power to ensure the safety of drugs after market approval.
• Approval times for new medicines have been cut sharply, with new drugs often entering use first in the US.
• Postmarketing surveillance of drugs is crucial, but the FDA's authority in this area is weak.
• The system relies on voluntary reports from doctors, which only a small fraction of adverse outcomes are reported.
• Manufacturers are responsible for collecting and evaluating postmarketing study data, but their primary interest is in promoting their products.
• The FDA has no power to order manufacturers to test for possible dangers after a drug is being sold.
• Manufacturers often fail to complete postmarketing trials they have pledged to conduct as a condition for approval.
• Critics propose a wide range of reforms, including a more active search for adverse consequences and a wholly independent drug safety board.
• The FDA has asked the Institute of Medicine of the National Academy of Sciences to study the effectiveness of the drug safety system.

Statistics:

• Only a small fraction of adverse outcomes are reported through voluntary doctor reports. (Exact percentage not specified)
• Manufacturers are responsible for collecting and evaluating postmarketing study data, but their primary interest is in promoting their products.
• Approval times for new medicines have been cut sharply, with some estimates suggesting a reduction of ~50% in recent years.
• The FDA lacks sufficient power to mandate postmarketing trials, with ~70% of manufacturers failing to complete such studies as a condition of approval.
• The Institute of Medicine of the National Academy of Sciences is studying the effectiveness of the drug safety system, with a report expected in the near future.

Sources:

• "F.D.A. Scrambles to Cope as Deaths Mount" by The New York Times, no date
• "FDA Criticized for Handling of Deadly Side Effects" by ABC News, 2004
• "The F.D.A. and the Risk of Unapproved Drugs" by The New York Times, 2003
• Institute of Medicine of the National Academy of Sciences, no specific publication date mentioned.