For the second time in the three years, independent federal investigators have determined that the U.S. Food and Drug Administration has failed to require the timely delivery of safety and efficacy data on medications the agency approved before pharmaceutical manufacturers have completed clinical trials. The FDA has also declined to take actions to remove medications subsequently found to be ineffective or more unsafe than beneficial, notes the Government Accountability Office in a report scheduled for publication on Oct. 26.
The Associated Press obtained a prerelease copy of the analysis of FDA’s accelerated approval–or “fast track”–program for medications and reported that “of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending.” The terms of a fast-track new drug approval allow a drugmaker to submit laboratory data as evidence of effectiveness. Then, however, companies must complete full trials in humans and submit the findings of those trials to the FDA.
Companies often delay their submission of clinical data for a decade or more, and the FDA has never rescinded a fast-tracked drug approval. One problematic fast-tracked medication singled out as a possible candidate for FDA-mandated market withdrawal is AstraZeneca’s lung cancer drug Iressa, which has the generic name gefitinib.
The FDA approved Iressa in 2003 when AstraZeneca showed that the medication shrank some tumors. When clinical evidence showed in 2005 that patients who received Iressa did not survive longer and tended to suffer serious side effects that decreased their quality of life and sometimes proved fatal, the FDA advised doctors only to stop prescribing Iressa to new patients.
Patients need to have complete confidence that the drugs they take will help them and not increase their risks for injury or death. The FDA fails to give patients these assurances when it allows medications to enter the U.S. market before the agency or anyone else knows whether the medications will harm more than it heals. To best serve and protect patients, the FDA needs to follow the GAO’s recommendations to press drugmakers to complete clinical trails of fast-tracked drugs and develop procedures for getting unsafe or ineffective fast-tracked drugs off the market.
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