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Congressman Larry Bucshon Applauds Committee Passage of Prescription Drug Bill

Washington, DC, May 11, 2012

Congressman Larry Bucshon (IN-08) released the following comment praising the Committee on Energy and Commerce for unanimous passage of the Prescription Drug User Fee Reauthorization Act (PDUFA), which includes important components of the bipartisan Drug Shortage Prevention Act introduced by Congressman John Carney (D-DE) and Congressman Bucshon.

Congressman Bucshon (IN-08) states:

            “It is critical that we address the issue of drug shortages on behalf of patients that depend on life-saving medications.  I would like to praise the Energy and Commerce Committee for unanimously passing the reauthorization of the drug user fees and including provisions of the Drug Shortage Prevention Act.  As a physician, I urge bipartisan support on the bill’s passage and encourage the Senate to do the same. ”

Background:

A number of key provisions from the Drug Shortage Prevention Act are included in the PDUFA legislation, including:

  • Creation of a publically available Drug Shortage List with information about the reason for the shortage and estimated date by which drugs will begin reaching providers in a quantity sufficient to meet demand
  • If a drug on the critical drug shortage list pertains to a controlled substance subject to a quota, the Attorney General is directed to increase the quota, in consultation with the Secretary of Health and Human Services, to address the critical drug shortage.
  • If a manufacturer of a drug in shortage wants to make a change to the manufacturing process of that drug in order to mitigate or prevent a shortage, FDA must expedite the review of that request.

Congressman Bucshon and Congressman Carney are members of a Bipartisan Working Group that regularly meets to discuss issues of importance.  The Drug Shortage Prevention Act was developed due to their participation.

The Senate Committee on Health, Education, Labor & Pensions passed similar legislation in April. Both the full House and Senate are expected to hold final passage votes on PDUFA by the end of June.

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