Most drug companies benefiting from the FDA’s “accelerated approval” process—a means of expediting approval of drugs intended for patients with life-threatening illness—have not conducted legally required post-marketing studies on their products, according to Rep. Edward J. Markey (D-MA).*
Created in 1992, the FDA’s accelerated approval process uses preliminary data indicating drug safety and efficacy to help bring drugs to the marketplace more quickly. This process greatly reduces the typical 10- to 15-year time period required to conceive, develop, and thoroughly test new drugs in animals and humans. In return for the enormous marketing advantages realized by drug makers, it was agreed that rigorous studies validating the preliminary data would continue in accordance with normal approval procedures.
Released on June 1, 2005, Rep. Markey’s report, Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process, reveals that at least 17 drug companies have not completed the FDA-required post-marketing studies. Of the 91 post-marketing studies promised since 1992, only 49 have been completed. Of the 42 pending studies, half have not even been initiated, though some of the approved drugs have been on the market for years; three are in progress but behind schedule; and only 18 are currently meeting scheduled milestones.
Although the FDA has the authority to withdraw drugs from the market in the absence of supporting data, it has not done so in any cases. The need for post-approval studies is well illustrated by AstraZeneca’s Iressa®, approved in May 2003 to treat non-small cell lung cancer. While preliminary data suggested that Iressa® would benefit 10% of patients, the FDA’s review of the mandated follow-up studies by AstraZeneca concluded that Iressa® provided no survival benefit and that patients taking it should discuss treatment alternatives with their physicians.
The FDA must enforce its requirements for post-marketing studies by drug makers in order to protect public safety.
—Linda M. Smith, RN