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U.S. Senate HELP Committee Releases Draft Legislation to Address Drug Shortages

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The U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) released a discussion draft of legislation aimed at addressing ongoing prescription drug shortages that are affecting hospitals’ ability to provide the most appropriate and effective treatments to patients.

Led by HELP Committee Chairman Tom Harkin (D-IA) and Ranking Member Michael Enzi (R-WY), a bipartisan working group of 18 senators developed the draft with the hope of creating consensus on drug shortage provisions for inclusion in a broader bill to reauthorize the federal Food and Drug Administration (FDA) medical device user fee program, which expires on September 30.

HANYS is working with the American Hospital Association (AHA) in urging Congress to provide FDA with appropriate resources and funding to ensure sufficient capacity and ability to facilitate resolution of drug shortages. Last week, HANYS held a special session with HANYS’ member chief operating officers and AHA to strategize on these efforts.  

The Harkin-Enzi draft would:

  • require prescription drug manufacturers to provide FDA at least six months prior notice of manufacturing disruptions or discontinuance;
  • expedite FDA approval of new drug application and inspection of production facilities in shortage situations; and
  • create a task force charged with mitigating current and preventing future shortages by improving interagency coordination and developing a strategic plan for regulatory action;
  • improve FDA’s recordkeeping of shortages and corresponding actions to address them and require a report to Congress on drug pricing.

The draft is subject to modification as interested parties weigh in with the committee.

Similar legislation is under development by the House Energy and Commerce Committee. HANYS strongly supports the Preserving Access to Lifesaving Medications Act (S.296/H.R. 2245), which would also require early notification of impending shortages.

HANYS and AHA are also pursuing a regulatory agenda that includes urging that FDA take steps to expedite drug approval, improve recognition of potential shortages, and bolster communications with health care providers.  Contact: Chelsi Stevens


Published April 10, 2012