U.S. Congressman John Carney (D-DE) today praised the House Energy & Commerce Committee's unanimous passage of the Prescription Drug User Fee Reauthorization Act (PDUFA), which includes important components of Congressman Carney's Drug Shortage Prevention Act.
"Each year, the problem of drug shortages continues to worsen. Today's developments are encouraging for all of the patients across America who are not getting the treatments they need because of preventable drug shortages," said Congressman Carney. "The changes I've proposed in this legislation will ensure that more of these critical drugs are produced by manufacturers and reach the patients who need them. I thank my colleagues for their support and look forward to swift Senate action and full passage of this legislation in the coming weeks."
A number of key provisions from Congressman Carney's drug shortage prevention bill 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.
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.