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The drug-shortage crisis got a step closer to being alleviated Thursday, when the U.S. Senate passed FDA?s Safety and Innovation Act (SB-3187).
The drug-shortage crisis got a step closer to being alleviated Thursday, when the U.S. Senate passed FDA’s Safety and Innovation Act (SB-3187).
SB-3187 requires drug manufacturers to notify the FDA as soon as possible when they experience a product interruption and 6 months in advance if a product will be discontinued. The early notification requirement is expected to alleviate more drug shortages, since the FDA was able to avoid 195 shortages in 2011 because of early notification.
The House is expected to pass a similar bill, the FDA Reform Act (HR-5651), next week and leaders anticipate presenting a bill to President Barack Obama by early July, according to media reports.
“The resounding vote of 96-1 demonstrates the overwhelming need to give the FDA the tools to address a crisis that has resulted in undue risk to patients,” said American Society of Health-System Pharmacists (ASHP) CEO Paul W. Abramowitz, PharmD, FASHP.
The legislation also codifies FDA authority to expedite the review of products and new drug applications, and creates a generic user fee program that will help speed FDA approval of generic applications and encourage additional manufacturers to enter the marketplace, according to a statement from ASHP.
ASHP and several other groups, including the American Society of Clinical Oncology and the Institute for Safe Medication Practices, worked closely with a bi-partisan group of legislators to develop the drug shortages provisions in the bill.