DeGette Hails Results of GAO Study on Drug Shortages
December 15, 2011
WASHINGTON – U.S. Rep. Diana DeGette (CO-1) today hailed the results of the Government Accountability Office's (GAO) study, entitled, "Drug Shortages: FDA's ability to Respond Should be Strengthened."
The study found that most shortages were generally caused by manufacturing problems, and that the FDA (Food and Drug Administration) is "constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages." DeGette is the author and lead co-sponsor of the "Preserving Access to Life-saving Medications Act" which would give the FDA the full authority it needs.
"The GAO findings released today underscore the critical importance of enacting legislation that provides the FDA with the tools it needs to deal with drugs headed towards shortage. I particularly applaud their recommendation today that Congress establish a requirement for manufacturers to report to FDA any changes that could affect the supply of their drugs.
"My drug shortage legislation would do just that, legally requiring any manufacturer of any prescription drug to notify the FDA of any discontinuance or interruption in the production of their drug. In fact, since the President's Executive Order on October 31, the FDA has seen a six-fold increase in notifications from manufacturers. As the number of potentially life-threatening drug shortages continue to grow, the GAO study and the FDA's results make clear that it is time for Congress to come together and pass bipartisan legislation requiring notification."
Also today, the FDA released a regulation – an interim final rule – that would clarify that companies should report on interruptions that could lead to disruptions.
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