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FDA Nominee Crawford Still In Limbo; Grassley Wants More Answers

This article was originally published in The Tan Sheet

Executive Summary

Senate Finance Committee Chairman Charles Grassley (R-Iowa) is not satisfied with FDA Commissioner nominee Lester Crawford's answers to written questions posed as part of the confirmation process

Senate Finance Committee Chairman Charles Grassley (R-Iowa) is not satisfied with FDA Commissioner nominee Lester Crawford's answers to written questions posed as part of the confirmation process.

Grassley does not sit on the Senate Health Committee, which is responsible for vetting Crawford's nomination. However, the Iowa Republican helped raise the issues surrounding FDA's handling of post-marketing safety to national prominence with a November hearing on the withdrawal of Merck's Vioxx .

Grassley submitted a list of 30 questions for the nominee in late March, saying his eventual support for Crawford would depend on the answers. Crawford has replied to Grassley's inquiry, but Grassley considers the responses to be incomplete.

The written record will not be publicly released until Crawford provides answers that are deemed suitably complete.

The questions covered a spectrum of issues related to FDA, ranging from Crawford's opinion on drug safety user fees to direct-to-consumer advertising.

Grassley's concerns mark another bump in the road for Crawford's nomination.

Democratic members of the Health Committee threatened to place a hold on Crawford's nomination until FDA makes a decision on Barr's Rx-to-OTC switch application for the emergency contraceptive Plan B .

A planned vote on the nomination was cancelled April 13, and the committee disclosed that it has requested an investigation into a conduct allegation lodged against the nominee (1 (Also see "FDA Confirmation Process Hits A Roadblock: Time For Plan B?" - Pink Sheet, 18 Apr, 2005.), p. 5).

The Health Committee has not yet rescheduled a vote, although the leadership continues to expect action before the Senate recesses in May.

Prominent Republicans on the committee, including former chairmen Judd Gregg (N.H.) and Orrin Hatch (Utah), say they expect Crawford to be confirmed. Hatch, however, added that it is important that the allegation against Crawford be investigated thoroughly in order to quash the rumors.

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