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March 10, 2006
New docs raise questions about FDA’s handling of EC
New documents obtained by Rep. Henry Waxman (D-CA) reveal some pretty disturbing things about the FDA’s decision-making process on over-the-counter availability of emergency contraception.
The documents show that FDA policymakers had no problem with over-the-counter sales of EC in 2004, but that a year and a half later former FDA Commissioner Lester Crawford brought up concerns about teens:
The FDA records indicate that the change was engineered by FDA senior officials who worked behind the scenes against the company while appearing to remain neutral.
...In a letter to acting FDA Commissioner Andrew von Eschenbach that was released Thursday, Waxman contends that the FDA "created a regulatory `Catch 22' to justify the predetermined political decision to block over-the-counter sales of Plan B."
"In essence, the agency was well aware of the regulatory questions that would arise when it suggested age restrictions, but simply did not resolve them in a timely manner," Waxman wrote. Waxman's office wouldn't disclose the source of the documents.
...In a letter to acting FDA Commissioner Andrew von Eschenbach that was released Thursday, Waxman contends that the FDA "created a regulatory `Catch 22' to justify the predetermined political decision to block over-the-counter sales of Plan B."
"In essence, the agency was well aware of the regulatory questions that would arise when it suggested age restrictions, but simply did not resolve them in a timely manner," Waxman wrote. Waxman's office wouldn't disclose the source of the documents.
More to come as we get more info, but this is pretty interesting stuff...
Posted by Jessica at March 10, 2006 10:36 AM
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