The US Food and Drug Administration’s decision last month to postpone a decision on whether the emergency contraceptive Plan B should be made available over-the-counter has prompted 13 US Senators to seek a non-partisan probe into the agency’s actions.
The group, which includes Democrats Hillary Rodham Clinton and Patty Murray, is asking the General Accounting Office to investigate the FDA’s actions in the long-running review process, amid allegations that political issues have interfered in what should have been a decision based on scientific and health grounds.
The US Food and Drug Administration had originally promised a verdict on whether to allow Plan B to be made available OTC by September 1, but reneged on this saying a decision should be made via a public forum [[31/08/05b]]. The assistant FDA Commissioner for Women’s Health, Susan Wood, resigned in the wake of this announcement, saying that the clinical evidence supported the approval of the drug, but that this verdict had been overruled [[01/09/05d]]. However, the FDA says the main sticking point is whether a drug can legally be made available OTC and on prescription in the same format and packaging.
In a letter, the Senators ask the GAO to investigate why it has taken two years to review the emergency contraceptive, made by Barr Laboratories, despite a positive recommendation for approval by the agency’s own advisory committee in December 2003. The GAO was first asked to look into the matter in July 2004.
Sens Murray and Clinton have repeatedly called for a yes or no answer from the FDA and dropped their hold on the nomination of Lester Crawford to head the FDA after the September 1 deadline for the Plan B verdict was announced.