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Mylan CEO Heather Bresch Testifies Before Congress in Support of Generic Drug User Fee Program and Urges Update of Federal Food, Drug and Cosmetic Act of 1938 to Create a Level Playing Field for Manufacturers
Date:2/9/2012

on No. GAO-10-961). (September 2010).

[2] Deborah M. Autor, Deputy Commissioner, U.S. Food and Drug Administration, Ensuring the Safety, Efficacy, and Quality of Drugs, A Roundtable on Ensuring the Safety of the U.S. Drug Supply, Mar 14-15, 2011. 

[3] See GDUFA goals letter for further explanation of risk basis.  See also GPhA's testimony before the Senate HELP Committee, dated Sept. 17, 2011. (A "risk-based" model for inspections prioritizes inspections according to a company's safety and compliance track record. This system would ensure that questionable or problematic facilities receive a comprehensive review and evaluation sooner. Facilities with strong records of compliance and positive inspections would be placed further down on the inspection schedule, allowing the agency to prioritize its immediate attention on companies that have never had an inspection or that have a history of compliance issues.)

[4] Pew Health Group, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, at 27.


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