Former FDA Chief Counsels Examine the Shifting Sands of FDA Enforcement Policy

The dramatic decline in the number of product seizures was cited as one indicator of the shifting sands of FDA enforcement policy by a panel comprising several decades of former FDA chief counsels at the Food and Drug Law Institute (FDLI) annual meeting in late April in Washington, DC.

During the Q&A-format session, the panelists explored enforcement policy changes that have taken place, the reason for the changes and their impact.

The tenures of the seven panelists extended over the four decades from 1971 to 2011. Bracketing the panel were Covington and Burling Senior Counsel Peter Barton Hutt, who served as chief counsel from 1971-75, and Venable Partner Ralph Tyler, who held FDA’s legal helm in 2010 and 2011.

The panel also included Williams and Connolly Partner Richard Cooper (1977-79), attorney Nancy Buc (1980-81), and the three chief counsels under the Bush Administration – GlaxoSmithKline Senior VP and General Counsel Daniel Troy (2001-04), Hunton and Williams Partner Sheldon Bradshaw (2005-07), and Covington and Burling Partner Gerald Masoudi (2007-09).

The decline in seizure actions was pointed to by the panelists as indicative of other significant shifts in FDA’s enforcement program and priorities.

Hutt commented that “to go from almost 900 seizures [during his tenure] to at most 10 or 20 a year today is truly a huge difference.”

He attributed the decline to three primary reasons: ● the increase in premarket approvals ● the expanded use of warning letters, and ● changes in who decides on taking a criminal, seizure or injunction action.

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