U.S. may speed approval of "breakthrough" drugs

Under a proposal likely to become law later this year, U.S. drug regulators would be able to  label promising treatments as "breakthorugh" therapies to speed their path to approval. 

At Reuters.com, journalist Anna Yukhananov writes that the proposal would allow drug regulators to "work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients...The plan fits with President Barack Obama's aim to foster innovation as a means of spurring job creation, and may pacify some critics who say the FDA lags European countries in approving new medicines or medical devices."

Yukhananov quoted Dr. Janet Woodcock, head of the FDA's drugs center, who in March asked reporters, "What happens when you have a breakthrough drug that shows an effect that's never been seen before? If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic."

Also quoted was Jeff Allen, executive director of Friends of Cancer Research, who commented, "The most promising drugs show an effect early. [But] there's a mentality mong drug developers or FDA reviewers that you have to go through this multi-step approach" to get a drug to market. We're hoping to encourage getting away from that."

Read more at Reuters.com.