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Congressman Larry Bucshon Praises Passage of Food and Drug Administration Reform Act of 2012

Congressman Larry Bucshon (IN-08) released the following comment praising the bipartisan passage of the Food & Drug Administration Reform Act of 2012 (H.R. 5651) by a vote of 387-5.  The legislation includes important components of the bipartisan Drug Shortage Prevention Act (H.R. 3839) introduced by Congressman John Carney (D-DE) and Congressman Bucshon.

Congressman Bucshon (IN-08) states:

            “I would like to applaud my colleagues for putting citizens first in passing the Food and Drug Administration Reform Act with overwhelming bipartisan support.  I was especially pleased to see provisions of the bipartisan Drug Shortage Prevention Act included to aid patients in obtaining critical medicines for their continued care.  As a physician, I strongly believe the reforms included in this legislation will help the United States maintain our role as the world leader in medical innovation and life-saving medical device and pharmaceutical manufacturing.”


A number of key provisions from the Drug Shortage Prevention Act are included in the 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.