Abuse in the FDA Accelerated Drug Program

Washington, DC: Representative Edward J. Markey (D-MA), today released a staff report: Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process. The report reveals that the majority of pharmaceutical companies benefiting from the Food and Drug Administration (FDA)’s “accelerated approval” process, a mechanism designed to expedite drugs for patients with life-threatening illnesses, have not conducted the post-marketing studies that are required by law on a timely basis. The SEC indicates that many drug companies have not disclosed information regarding postmarketing studies to their investors. Of the 91 studies required by the FDA, 42 studies have not been completed and half have not even started.

“It is outrageous that drug companies and the FDA have been dragging their feet when it comes to conducting required postmarketing studies. Pharmaceutical products approved under the accelerated approval process are designed to treat patients with life threatening illnesses, so ensuring the effectiveness of these drugs is a life or death matter for many patients,” said Markey. More Info

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