Last week, 62 members of Congress sent a letter urging Andrew von Eschenbach, acting commissioner of the Food and Drug Administration (FDA), to approve the emergency contraceptive Plan B for over-the-counter sales. “We are displeased that the FDA continues to delay, postpone, and create impediments to issuing a decision on an application that its own expert advisory committee endorsed nearly 20 months ago,” the members of Congress wrote. “Unfortunately, this important decision has been delayed too long and at the expense of women’s reproductive health throughout the country.”
The Government Accountability Office has been investigating the FDA’s May 2004 decision to give a “not approvable” letter to Barr Laboratories, the makers of Plan B, at the request of several Senators. The Senators requested the results of the investigation in September, and Congressional staffers have recently been granted some access to the draft report, although it has not yet been released.
According to the Washington Post, the denial was marked by the unusual involvement of top officials at the FDA, while Lester Crawford was serving as acting commissioner, and that Steven Galson, then-acting director of the Center for Drug Evaluation and Research, brought up his concerns about increased access leading to promiscuity. Furthermore, although Galson announced the decision as his own, there was evidence that the decision was made with other officials, and solidified months before the announcement, the Post reports.
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