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.
