The U.S. House of Representatives passed legislation last week that reauthorized the FDA drug and medical device review process, according to an ASC Association release.
The "Food and Drug Administration Reform Act of 2012," introduced as H.R. 5651, includes some significant reforms to prevent future drug shortages. The legislation will address the ongoing drug shortage crisis and reduce and alleviate shortages by:
The "Food and Drug Administration Reform Act of 2012," introduced as H.R. 5651, includes some significant reforms to prevent future drug shortages. The legislation will address the ongoing drug shortage crisis and reduce and alleviate shortages by:
- Requiring drug manufacturers to notify HHS of any discontinuance in the manufacturing of drugs that are considered life-supporting, life-sustaining or intended for use in the prevention or treatment of a debilitating disease.
- Requiring the FDA to maintain a public drug shortage list and information about how to prevent, mitigate and manage shortages.
- Requiring the DEA to approve or deny requests to increase quotas of any controlled substances within 30 days for any request pertaining to a drug in short supply.
- Requiring the FDA to issue an annual report on drug shortages.
- Requiring the DEA to issue an annual report on shortages of controlled substances.
- Allowing hospitals owned and operated by the same entity to repackage drugs into smaller units before the FDA issues final guidance.
- Requiring the Comptroller General of the U.S. to conduct a study examining the cause of shortages and make recommendations on how to prevent them.