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Drug Shortages Bill Headed to White House

6/27/2012

Thanks to ASHP’s multi-year effort to educate Congress about the public health crisis caused by drug shortages, along with work to build broad based support for the legislation in the health care community, we are closer than ever to protecting patients from the dangers posed by drug shortages. Today, the Senate passed the final version of S. 3187, “The Food and Drug Administration Safety and Innovation Act,” which included ASHP-supported drug shortages provisions. The House of Representatives passed the bill last week. The bill now goes to the President for his signature.

“This is a very important achievement for ASHP,“ said chief executive officer Paul W. Abramowitz, Pharm.D., FASHP. “We are gratified that the determined efforts of our members and our staff resulted in this resounding victory for patients.”

ASHP is widely viewed as the most credible source of information on drug shortages. In a year when Congress experienced inertia due to partisan disagreements, the Society took the lead in bringing both parties together to help address the drug shortages crisis in a bipartisan, rational, and thoughtful manner. The Society, in collaboration with key partners, including the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP), worked closely with legislators to develop the drug shortages provisions.

ASHP championed the provision which became the centerpiece of the drug shortages legislation –an early notification system that requires drug manufacturers to notify the Food and Drug Administration (FDA) of production problems or if a product will be discontinued. Failure to comply with the early notification requirement will trigger a letter from FDA.

The bill also gives the FDA authority to expedite the review of products and new drug applications; creates a generic user fee program; and allows for repackaging of medications in short supply to be used within the same health system.

President Obama is expected to sign the bill in the coming days.

 

Contact Us
For questions, comments, or more information on this article, please contact Ellen Wilcox, Director, Public Relations via telephone at 301-664-8799 or via e-mail at publicinfo@ashp.org.
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