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IPQ Inside the global regulatory dialogue

Protecting the Public Health Trumps Explicit Legislative Mandate, FDA’s Chief Counsel Tells FDLI

May 26th, 2010

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FDA’s mandate to protect the public health requires making decisions in situations where there is no law explicitly empowering it to act, FDA Chief Counsel Ralph Tyler stressed at the Food and Drug Law Institute (FDLI) Annual Meeting in late April.  In turn, Tyler explained that a key role for FDA lawyers is to be advocates for the agency in helping it reach its policy and enforcement goals in situations where waiting for approval from Congress does not allow a timely enough decision.

There are times when the agency is seeking to answer problems “which, if you asked the question, ‘did Congress have this in mind when they wrote this law?,’ the honest answer would be no,” explained Tyler, adding  “that kind of question arises with some frequency.”

Like every client, he said, FDA “is entitled to a lawyer who is its advocate.  Responsible advocacy does not mean advising that because Congress has not said, in just so many words,” what the agency’s power is that it should not take action.

[Editor’s Note:  The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.]

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