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HELP Committee Floats Discussion Drafts on Drug Shortages, Medical Devices

April 6, 2012—The Senate Health, Education, Labor, and Pensions (HELP) Committee has released a series of bipartisan discussion draft bills for public comment, reflecting the work of Senate working groups on prescription drug shortages and other topics. The committee plans to collect feedback “on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language” of the drafts, with the goal of supplementing upcoming reauthorization of the Food and Drug Administration (FDA)’s human medical product user fees.

The committee will accept written comments on the bipartisan draft bill on prescription drug shortages through close of business April 9. Among other provisions, the draft:

  • Allows the Secretary of Health and Human Services to expedite review of new drug applications and/or inspection of establishments that could mitigate the shortages and to apply such authorizations to biological products if it would benefit public health;
  • Directs the secretary to establish a task force to mitigate existing and prevent future shortages;
  • Directs the secretary to assess the potential of pending enforcement actions or letters to exacerbate shortages before proceeding;
  • Requires the secretary within two years to review related regulations, guidances, policies, and practices that may affect drug shortages; and
  • Requires a report within one year on how drug shortages have led to stockpiling or increased drug prices and the resulting effect on federal revenue.

The committee also released a bipartisan discussion draft on the regulation of medical devices, which proposes to include devices in the postmarket risk identification and analysis system.  The draft requires FDA to establish a unique device identifier (UDI) system “as soon as practicable.” The AAMC endorsed a similar proposal in the Ensuring Safe Medical Devices for Patients (S. 2193), introduced March 15 by Senators Jeff Merkley (D-Ore.), Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), and Herb Kohl (D-Wis.) [see Washington Highlights, March 23].

Other bipartisan discussion drafts released by the committee include the:

  • Drug Approval and Patient Access Draft;

  • Incentivizing New Antibiotic Development Draft; and

  • Drug Supply Chain Integrity Draft.

Staff contacts, draft language, and comment deadlines for each draft are available on the committee website.


Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559


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