October 1, 2007

Newly Appointed Acting Surgeon General Played Role in Holding Up OTC Sale of Emergency Contraception

Dr. Steven Galson, former Director of the FDA’s Center for Drug Evaluation and Research (the agency’s drug review and approval arm), has been appointed to the position of Acting Surgeon General, and is expected to begin the post today.

Dr. Galson’s selection for the post has raised concerns from reproductive health advocates, given Galson’s role in the years of delay that preceded the 2006 approval of over-the-counter sales of Plan B emergency contraception. His appointment follows recent complaints about the political pressure placed on past Surgeons General to avoid raising such issues as emergency contraception and sexuality education.

Galson issued the FDA’s 2004 “not approvable” letter in response to the Plan B maker’s application for OTC status, citing concerns about young women’s access to the drug. He was criticized for this initial ruling when it became known that “he rejected not only the judgment of an advisory panel but also the recommendations of his own staff when he refused to allow a morning-after pill to be sold over the counter.”

When the U.S. Government Accountability Office reviewed the decision-making process leading up to the 2004 rejection, they found certain aspects to be highly unusual, including Galson’s signing of the not approvable letter after the officials who would normally do so disagreed with the decision, the involvement of higher-level officials than is usual, reports that the decision was made prior to completion of the review, and the departure in the review from normal practices.

Additionally, in an Aug. 26, 2005 memo on Plan B, Galson opposed OTC access for young women, writing:

“The less developed cognitive abilities of women under age 17 could lead to inappropriate use of Plan B and the potential for younger women engaging in risky sexual behavior, behaviors which carry significant safety and efficacy concerns.”

This statement seems to align with the concerns of conservative groups who opposed the switch that increased access to Plan B would lead to sexual promiscuity. Galson later denied making this consideration in an Aug. 24, 2006 interview with PBS’s NewsHour in which he claimed that “The assessment of promiscuity was not part of our assessment.”

Galson told WebMD that he plans to immediately become active in the new role, stating, “In my mind the ‘acting’ is off the title. I am going to be the surgeon general and actively engage in policy and education.”

Janet Woodcock has been tapped to serve as Acting CDER Director following Galson’s departure, but will likely not depoliticize the role. In depositions regarding the Plan B decision, one former FDA official stated that she was called at home by Woodcock in 2004, who indicated that the switch to OTC status would only be done with an age restriction and “…conveyed to me her assurance that this was the only way to go, to issue a non-approval letter to appease the administration’s constituents, and then later this could be approved.”


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