FDA Soon to Issue Drug Shortage Notification Rule

The Food and Drug Administration is poised to publish a proposed rule to require notification from drug manufacturers of discontinuances or interruptions in the manufacturing of life-supporting and certain other important drugs.

The rule, sent to the Office of Management and Budget for final review before publication, is authorized under the Food and Drug Administration Safety and Innovation Act of 2012. Early notification of issues that could lead to shortages helped FDA prevent more than 100 shortages during 2012, according to the agency.

Now, early notification will be mandated. Under the new law and forthcoming rule, manufacturers of drugs deemed as life-supporting, life-sustaining or used in the prevention or treatment of a debilitating disease or condition must report expected production issues six months prior to discontinuation or interruption, or as soon as possible if six months notification is not practical.

A feature story in the February 2012 issue of Health Data Management addressed drug shortage issues and policies, and ways that information technology can be used to better manage or alleviate a shortage.