President signs AHA-backed drug shortages bill into law
July 23, 2012
President Obama July 9 signed into law as PL 112-144 the “Food and Drug Administration Safety and Innovation Act.” The legislation includes AHA-supported provisions to help alleviate critical drug shortages.
The legislation, a product of House-Senate negotiations, reauthorizes the user fees paid by medical device and drug companies and creates new user fee programs for generic drugs and biosimilar (or follow-on biologic) drugs. The Senate on June 26 adopted the conference report to the bill, S.
3187, and the House on June 20 approved it on a voice vote.
The new user fee law requires drug makers to report production interruptions and discontinuations to the Food and Drug Administration (FDA) in advance; codifies FDA’s authority to speed approval of applications to make drugs in short supply; lifts caps on narcotic ingredients to ensure sufficient supply for anesthesia, pain management and other critical uses; and improves communications with providers and patients about the reason for potential drug shortages and how long they may last.
The legislation also creates a user fee program that will help speed FDA approval of generic drugs, and allows hospitals within health systems to conserve their inventory of shortage drugs by sharing repackaged drugs. Read the text of the legislation athttp://republicans.energycommerce.house.gov/Media/file/PDFs/BILLS-112s3187-SUS.pdf.
AHA President and CEO Rich Umbdenstock called the legislation a “concrete step in the right direction” in addressing the growing number of drug shortages. “The number of drug shortages has tripled in the last six years and they are having an impact on patient care,” he said. “With nearly 100% of hospitals reporting shortages, access to life-saving drugs is essential. The law will help hospitals obtain that critical access.”
He said the legislation would help ease the strain that hospitals across the country have faced in dealing with drug shortages by improving communications between manufacturers and the public; providing FDA additional authority to speed up approvals; and allowing health systems to take practical steps to conserve their inventory of drugs.