FDA Moves to Curb Drug Shortages

Article

FDA Moves to Curb Drug Shortages

As required by the FDA Safety & Innovation Act (FDASIA) of 2012, FDA issued a Strategic Plan for responding to drug shortages Oct. 31, 2013, plus a proposed rule for how manufacturers should notify the agency of an interruption or discontinuation in production of a medically important therapy. The rule expands notification to a broader spectrum of drugs, including biologics, and advises on dealing with suppliers and contract manufacturers.

The Strategic Plan spells out how FDA can better respond to shortage situations and how manufacturers should avoid supply problems: build up inventories before making production changes, improve communications with contract manufacturers, and consider upgrades for aging facilities. There is support for incentives to companies that adopt manufacturing quality improvements and risk-based approaches, but few specifics on rewards for doing so.

Recent Videos
Behind the Headlines, episode 7
Behind the Headlines episode 6
CPHI Milan 2024: Highlighting the Benefits of Integrated Services
Behind the Headlines episode 5
Buy, Sell, Hold: Cell and Gene Therapy