FDA May Fast-track Needed Drugs

New congressional proposals would allow drug makers to bypass traditional clinical trial requirements for drugs that address rare diseases.

By | November 18, 2011


As part of the renewal of pharmaceutical licensing fees, Congress is considering two proposals for the US Food and Drug Administration to fast-track drugs that address rare diseases or conditions for which no approved cures exist.

Senator Kay Hagan, a democrat from North Carolina, and the Biotechnology Industry Organization have developed plans that would allow pharmaceutical companies to skip traditional clinical trial requirements for drug approval, in essence broadening the accelerated approval program used for cancer and AIDS drugs to include rare disorders.   According to the proposal, drugs that may qualify would address one of 7,000 conditions that affect fewer than 200,000 people per year in the country, Bloomberg News reported. Currently, only about 360 drugs are approved for those conditions, according the National Organization for Rare Disorders.

But the FDA already has an orphan drug program and existing methods to fast-track drugs for rare diseases, an FDA spokesperson told Bloomberg. For example, patients can access unapproved drugs if they enroll in a clinical trial or if their doctor submits an application. Since 2006, three quarters of the 85 treatments for rare diseases were approved based on limited clinical trial data, John Jenkins, the director of the Office of New Drugs, told Bloomberg.


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