President Obama today signed the FDA Safety and Innovation Act, which includes important components of Congressman Carney’s Drug Shortage Prevention Act. Last month, the House of Representatives and the Senate passed the legislation with broad bipartisan support.
“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 provisions from the Drug Shortage Prevention Act will ensure that more critical drugs are produced by manufacturers and reach the patients who need them. I thank my House and Senate colleagues for their support, and I'm glad that President Obama has signed this important legislation into law.”
A number of key provisions from Congressman Carney’s drug shortage prevention bill are included in the FDA 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.
• 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 between offices within FDA responsible for approving and regulating critical drugs and offices of FDA responsible for identifying and addressing critical drug shortages.
• 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.