ASHP is urging the U.S. Senate to finalize and pass legislation that includes key solutions to minimizing the drug shortages crisis.
The Senate Committee on Health, Education, Labor and Pensions (HELP) recently completed its work on the Prescription Drug User Fee Act (PDUFA) reauthorization legislation and voted to send it to the full Senate floor for consideration. The bill includes an ASHP-supported requirement that drug manufacturers notify the Food and Drug Administration (FDA) when they experience a production interruption or discontinue making a drug.
“We are very pleased with the HELP Committee’s work on this issue,“ said ASHP Chief Executive Officer and Executive Vice President Paul W. Abramowitz, Pharm.D., FASHP. “Our members and staff have worked tirelessly to advocate for congressional action. We still have a long way to go, but a major step has been accomplished toward our ultimate goal.”
PDUFA, which was first passed in 1992 and must be reauthorized every two years, allows the FDA to collect fees from drug manufacturers to fund new drug approvals. The bill must be approved by September 30.
Read ASHP’s letter of support