The FDA is on board with a proposal to speed the approval of experimental pharmaceuticals that show big treatment effects early in clinical testing.

By | May 14, 2012

image: Approving Wikimedia Commons, Ayena


Proposed legislation could allow the US Food and Drug Administration to label experimental treatments that demonstrate a sizeable impact early on in clinical trials as "breakthroughs," working with the companies that developed them to get them on the market sooner.

The FDA has already said that it supports the bill, which would give the agency the ability to speed the approval process for drugs that seem to treat life threatening illnesses like cancer and AIDS. "What happens when you have a breakthrough drug that shows an effect that's never been seen before?" Janet Woodcock, head of FDA's Center for Drug Evaluation and Research, asked reporters in March. "If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic."

Jeff Allen, executive director of Friends of Cancer Research, told Reuters that drug companies seeking to make drugs that target deadly diseases would welcome the new rules, which are set to be passed as part of an FDA funding bill by the end of the summer. "The most promising drugs show an effect early," he said. "(But) there's a mentality among drug developers or FDA reviewers that you have to go through this multi-step approach" to get a drug approved. "We're hoping to encourage getting away from that."

This legislation parallels the Faster Access to Specialized Treatments (FAST) Act making its way through Congress now. The FAST Act would extend the type of fast-tracked approvals already enjoyed by makers of cancer and HIV/AIDS drugs to developers of compounds that treat Parkinson’s, Alzheimer’s, diabetes, and other diseases.


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