U.S. Congressman John Carney (D-DE) today praised the Senate's 96-1 passage of the Prescription Drug User Fee Reauthorization Act (PDUFA), which includes important components of Congressman Carney's Drug Shortage Prevention Act. On May 10th, the House Energy & Commerce Committee unanimously passed similar legislation. The full House is expected to vote on its version of PDUFA next week.
"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 full passage of this legislation in the near future."
"My colleagues and their patients are confronted with prescription drug shortages every day," said Dr. Nick Petrelli, Medical Director of Christiana Care's Helen F. Graham Cancer Center. "These shortages are life-threatening, and expensive, and our patients are in dire need of relief. I'm encouraged that Congressman Carney has been able to advance some important measures to deal with this crisis."
A number of key provisions from Congressman Carney's drug shortage prevention bill are included in the Senate version of the PDUFA legislation, including:
Expedited review of any application seeking approval of a critical drug and any request by a manufacturer of a critical drug to approve a change to the manufacturing process or facilities of that drug in order to mitigate or prevent a shortage.
Improved regulation of critical drugs to ensure that, at each stage of the regulatory process, the status of drugs as critical drugs is taken into consideration.
Development of improved communications protocol between offices within FDA responsible for approving and regulating critical drugs and offices of FDA responsible for identifying and addressing critical drug shortages.
Requirement that FDA communicates any new regulatory concern identified about a critical drug to the office within FDA responsible for identifying and addressing critical drug shortages.