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FDA Report Card 2015: Enforcement

Enforcement

I do believe that FDA fundamentally tries to be fair. In the context of enforcement, however, I do not think FDA has been as evenhanded as they should be. The agency seems to pursue established medical device companies on many issues they do not seem to be enforcing with other, smaller firms.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Perhaps, the most popular method for evaluating enforcement performance is through issuance and examination of warning letters, for which there may be too many, in particular, as to the subjective application of the GMP/QSR regulation. The FDA author can only allege that a violation may have occurred, because the ultimate decision is through entry of a Consent Decree in Federal Court or adjudication through Trial. Unlike the smaller numbers of device seizures which ultimately settle, the Department of Justice has failed to prove FDA allegations through trial in federal court.

Larry R. Pilot, attorney at law

              

          
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