FDA May Fast-track Needed Drugs

FLICKR, CANDY

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...