- Consistent with his previously announced plan to reboot the FDA aimed at more timely reviews, Commissioner Scott Gottlieb, M.D. unveils a new plan to eliminate the backlog of Orphan Drug requests in the next 90 days and establishing a benchmark of responding to new requests within 90 days of receipt. Currently, the agency has ~200 applications pending review. Last year, it received 568 requests, more than double the amount received in 2012.
- The FDA's tactics will include a "Backlog SWAT team" of senior reviewers with significant expertise in the area. Requests will be reviewed on a FIFO basis (oldest ones reviewed first).
- In order to respond to new applications within 90 days, the review staff will be reorganized to improve efficiency and maximize expertise. A new Orphan Products Council will be established to help address scientific and regulatory issues to ensure a consistent approach in regulating orphan drugs and reviewing designation requests.
- Selected tickers: BIB IBB XBI PBE CNCR PJP IHE XPH PPH
- Now read: McKesson (NYSE:MCK)'s Rally Just Beginning
Original article