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FDA’s Ex-Chief Counsel Knocks Timing of Critical Report on Prescription Labeling Rules

October 31, 2008

On Wednesday, the House Oversight and Government Reform Committee released a report showing that at least two top FDA officials objected to making changes to federal rules regarding labeling for prescription drugs. The changes, made in 2006, created a new labeling system, with the most important warnings for doctors placed in a “highlights” section at the top of a label’s first page.

 

The new rules also banned drug companies from adding warnings to “highlights” sections without prior FDA approval — a move that critics claim was aimed at pre-empting lawsuits against drug companies. The report from U.S. Rep. Henry A. Waxman, D-Calif., who is chairman of the committee, suggests FDA officials made the changes to follow a Bush administration policy of protecting drug companies.

 

The report’s release comes as the U.S. Supreme Court is set to hear arguments Monday in the landmark Wyeth v. Levine pre-emption case.

Sheldon Bradshaw, now a partner at Hunton & Williams, oversaw the labeling-regulation overhaul in question during his stint as the FDA’s chief counsel from 2005-2007. He chatted about the House report and other issues with The Am Law Daily.

 

Read Article: Law.com

 

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