FDA Confirmation Process Derailed: Time For Plan B?
This article was originally published in The Pink Sheet Daily
Executive Summary
Senate Committee says it is investigating a conduct allegation raised about Crawford. Disclosure has the hallmarks of an attempt to torpedo the nomination – and helps shift debate over Crawford away from FDA's handling of Barr emergency contraceptive.
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Acting FDA Commissioner Lester Crawford's prospects for Senate confirmation are in jeopardy after the Health Committee disclosed concerns about a conduct allegation lodged against the nominee. After the April 13 vote on Crawford was cancelled abruptly, committee staff said that the issue was an eleventh-hour anonymous allegation that the leadership felt merited further investigation. In the context of the confirmation process, the disclosure has the hallmarks of an attempt to torpedo the nomination. The publicity about the existence of an allegation predictably touched off speculation about its nature and substance. More importanly, it shifts the confirmation debate away from concerns about FDA's handling of Barr's application for OTC availability of the emergency contraceptive Plan B . Democratic Sens. Hillary Clinton (N.Y.) and Patty Murray (Wash.) had threatened to put a "hold" on Crawford's nomination based on what they characterized as his unwillingness to commit to a timeline for reaching a decision on the application. FDA's drug review group is understood to have decided to approve the product for "behind-the-counter" use - which would mark a regulatory milestone in the U.S. (1 (Also see "Plan B Headed For Behind-The-Counter Sale" - Pink Sheet, 13 Apr, 2005.)). Barr said April 14 that it has received contradictory information about the status of the Plan B application, but it has not yet been approved. Democrats on the committee believe the hearing was cancelled because the Republican leadership is concerned about FDA's decision to approve the switch. Committee Chairman Michael Enzi (R-Wyo.) and Ranking Democrat Ted Kennedy (D-Mass.), however, issued a joint statement announcing that the vote was cancelled because of "issues that have been raised on both sides of the aisle." The committee says it received an anonymous complaint April 12; however, the substance of the complaint appears unlikely to have been overlooked in the vetting process. The White House reacted to the delay by expressing its hope that the issues would be resolved quickly, and reaffirming the President's view that Crawford is well-qualified for the post. HHS Secretary Leavitt made it clear at several points during his confirmation process earlier this year that the FDA nomination was being handled by the White House. If the Crawford nomination collapses, the consequences to FDA could be significant. Although Crawford is already in place at the agency, the perception of a conduct issue would presumably require his departure. The FDA commissioner position has already proven to be a tough job to fill. Since David Kessler left FDA in 1997, interim commissioners (Michael Friedman, Bernard Schwetz and Crawford, twice) have served longer than fully confirmed appointees (Jane Henney and Mark McClellan). - Michael McCaughan, Ramsey Baghdadi |