GAO: FDA leaves seniors out of drug trials

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Drugs approved by the Food and Drug Administration may not necessarily be safe and effective for seniors, a new report published this week from the Government Accountability Office said. The reason is because seniors are not always included in clinical trials.

In some cases, selected drug trials restricted the participation of seniors, according to the report, "Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials." Rep. Henry A. Waxman (D-CA), chairman of the House Oversight and Government Reform Committee, and Sen. Edward M. Kennedy (D-MA), chairman of the Senate Committee on Health, Education, Labor and Pensions, released the report's findings.

The FDA also has failed to clarify important requirements in the drug evaluation process for seniors, the report said. For example, the FDA does not require medical officers to determine whether a sufficient number of seniors participated in drug trials.

See the GAO report at