Senators question FDA nominee about timing of Plan B announcement

[JURIST] Democratic senators criticized the acting director of the US Food and Drug Administration [official website] Tuesday for the timing of the agency's announcement that it would reconsider allowing some over-the-counter sales of emergency contraception. Monday's surprise announcement [FDA press release] came on the eve of a confirmation hearing [committee materials] for Dr. Andrew von Eschenbach [official profile], the acting FDA commissioner and President Bush's nominee to lead the agency permanently. Sen. Tom Harkin (D-IA) [official website] accused von Eschenbach of putting "ideological concerns" before science, while Sen. Edward Kennedy (D-MA) [official website] speculated that the decision was a "delaying tactic." Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) [official websites] threatened to block von Eschenbach's nomination until the FDA makes a final decision on the so-called morning-after pill, marketed by Barr Pharmaceuticals Inc. [corporate website] under the brand name Plan B [product backgrounder]. Von Eschenbach said his decision was based on medical data, echoing remarks in his prepared statement [PDF text] that the FDA should be "guided by sound science and vigorous analysis of evidence."

On Monday, the FDA released a letter [text] from von Eschenbach to a Barr subsidiary, asking the company to amend its application to market Plan B for over-the-counter sale. Among the changes von Eschenbach requested was raising the minimum age to purchase Plan B from 16 to 18. In a lawsuit seeking over-the-counter Plan B sales for all ages, a former FDA commissioner testified that the agency delayed a decision [JURIST report] while it considered how to restrict nonprescription access only to females 17 and older. AP has more.



 

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