Study: One-third of pre-approved drugs has not finished FDA approval process

By Tauren Dyson

Aug. 27 (UPI) -- Pharmaceutical companies have failed to comply with federal policies that could speed up the approval of potentially life-saving prescription drugs, new research shows.

More than 1 in 3 drugs that have already received pre-approval from the Food and Drug Administration still haven't gotten the final approval required by the agency's Accelerated Approval Program, according to a study presented at the University of Hong Kong.


The program, which launched in 1992, was designed to speed up the approval process for drugs that treat life-threatening illnesses. That's only if the drug has been proven to have a clinical benefit.

Since its inception, the Accelerated Approval Program has sped up the approval process for drugs that treat HIV, anthrax exposure, pulmonary tuberculosis and non-small cell lung caner.

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"Manufacturers apparently have little incentive to do the post-market studies because they are not easily enforced and they are expensive," Liang Xu, a researcher at University of Nebraska-Lincoln and study lead author, said in a news release. "Withdrawing a drug from the market takes time and without proof of ineffectiveness cannot be enforced immediately."


Between 1992 and 2008, 36 percent of post-market studies have yet to be completed, even after the companies committed to completing them. That includes 50 percent of studies that have taken five years just to begin.

This problem has created a dilemma for FDA regulators. They are eager to provide potentially life-saving drugs to people with terminal illnesses but hesitant to pose a health risk if the medications don't work.

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Right now, the FDA requires companies to pay an application fee to start the approval process.

To help move along the process, the researchers say the FDA should institute the fee after the approval process.

"Currently, the FDA requires drug manufacturers to pay a fixed fee to fund its new drug application review. By replacing this fixed fee with a new one tied to a post-market study deadline, we can leverage an existing tool to make sure these studies get done," said Xu.

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