The FDA wants drugmakers to take another look at some existing drugs. The agency released a list of 235 meds that show promise as treatments for rare diseases, in hopes that companies would develop them accordingly. But given the cost of clinical trials--and the possibility that pricing pressures and small rare-disease markets might make it tough to recoup those costs--the FDA is facing an uphill battle.
"Large pharmaceutical companies are not as engaged as we'd like to see them be," Tim Cote, head of the agency's Office of Orphan Product Development, tells Bloomberg. "I myself have knocked on the doors of all the big boys."
Among drugs on the list are Roche's hepatitis remedy Pegasys as a possible cancer treatment; Biogen Idec's multiple sclerosis drug Avonex, tagged as a possible lymphoma med; and Johnson & Johnson's leukemia drug Leustatin, identified as a possible remedy for other forms of the blood cancer, Bloomberg reports.
When contacted by the news service, the companies said they're not studying those drugs for the indications FDA mentions, but they did affirm their commitment to finding remedies for rare diseases. For instance, Roche may no longer be studying Pegasys as a cancer treatment, but "[t]he company has pursued studies and applications for several orphan indications," spokeswoman Kristina Becker tells Bloomberg.
- check out the FDA database
- read the Bloomberg story