Unproven Drugs Are Still On The Market

Gary Shipman

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According to the GAO, the FDA “has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives.” It is also said to be questionable if the FDA even performed follow-up studies on these drugs. The FDA’s 16 year accelerated approval program, was designed to allow drug makers to bring products to market sooner under the “strict” condition that they conduct follow-up studies. The GAO is critical of the FDA and their “so-called ‘accelerated approval program.” The GAO “identified several drugs still on the market that never lived up to their initial promise” and out of the 16 year program the FDA has “never once pulled a drug off the market due to missing or unimpressive follow-up data.”

Since the GAO has completed its reports, the FDA claims to have “overhauled [its] tracking system. Principal Deputy Commissioner Dr. Joshua Sharstein said that there is not a policy in place for the FDA to pull drugs off the market because “we don’t want to lock ourselves into a specific set of criteria.” Dr. Sharstein is also on record saying “the agency has a task force assigned to look at polices like drug withdrawals.”