HHS to Handle FDA Nominee’s Investigation as Debate Over EC OTC Continues

The allegations that Lester Crawford, President Bush’s nominee to head the Food and Drug Administration, had an inappropriate personal relationship with a female colleague have been referred to the inspector general of the Department of Health and Human Services (HHS). The Senate Health, Education, Labor and Pensions Committee received an anonymous letter on Wednesday, prompting Senator Mike Enzi (R-WY) to ask the FDA’s internal affairs office to investigate the allegations. While the FDA Office of Internal Affairs reports to the FDA commissioner, the HHS inspector general’s office is an independent operation, according to the Washington Post. A spokeswoman for the inspector general’s office, Judy Holtz, said that she was unable to anticipate when the investigation would be completed, reports the Washington Post.

Crawford’s confirmation was postponed on Wednesday when the Senators learned of the letter’s accusations. Crawford, who has been serving as acting commissioner of the FDA for over a year, has also come under fire for not offering a decision on over-the-counter (OTC) status of the emergency contraceptive Plan B, despite two expert FDA advisory panels that voted 23 to 4 to recommend its availability in December 2003.

Barr Pharmaceuticals Inc., the makers of Plan B, announced plans on Thursday to pursue individual US states if the FDA rejects over-the-counter sales of Plan B, reports Reuters. Barr previously received a not-approvable letter from the FDA in response to its request to make Plan B available OTC. To comply with the conditions under which the FDA would OTC sales, Barr resubmitted its application limiting OTC sales of Plan B to women 16 and older. Prescriptions would still be required for girls 15 and under. Although the FDA was expected to make its decision by January 21, it announced an indefinite delay.

Crawford’s nomination was further complicated earlier this month when Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) announced that they planned to block his confirmation until the FDA resolves the issue of granting OTC status to EC.

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Reuters 4/14/05, Washington Post 4/16/05, Feminist Daily News Wire 4/7/05, 4/14/05

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