FDA recently commented on the report entitled “FDA’s Contribution to the Drug Shortage Crisis” for the Honorable Elijah E. Cummings. Within this letter from Jeanne Ireland, Assistant Commissioner for Legislation, she lays out the FDA’s response to specific questions that Mr. Cummings asks about Drug Shortages and whether the FDA contributed to them. His letter includes:
“The report references Warning Letters sent to several companies that manufacture drugs that are or have been in short supply suggesting that FDA actions inappropriately resulted in the shutdown of these facilities. …Please provide a brief history of the activities at these facilities resulting in FDA’s enforcement actions, and please provide a summary of 483-inspection findings and how underlying manufacturing concern related to product safety.”
Ms. Ireland discusses some of the serious manufacturing or quality problems found at four firms cited in the report that led to Form 483s and/or Warning Letters. The companies included Teva, Ben Venue Labs (BVL), Hospira, and Sandoz/Novartis.
The above report asserts that a majority of the shortages were caused by excessive regulation and enforcement actions related to manufacturing issues. The FDA reported in October 2011 that 43% of the shortages were caused by problems at manufacturing facilities, and that the remaining 57% of shortages were caused by a variety of either problems, many of which fall outside of the scope of the agency’s purview to include delays in manufacturing or shipping (15%), shortages of ingredients (14%), and manufacturers’ business decisions to discontinue production (8%). The FDA reported that in 2012, quality-related problems and delays have continued to account for the majority of shortages, especially those involving sterile injectable drugs.
Please visit the following web site http://freepdfhosting.com/8cbf071cad.pdf to view the entire FDA response.
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