Wednesday, May 12, 2004

Plan B Approval, Part III

This, in a nutshell, is the problem with FDA's decision about Plan B:

The Scientists:

In December 2003, two FDA expert advisory panels overwhelmingly recommended approval of the drug by a 23-to-4 vote, after reviewing more than 15,000 pages of clinical data from approximately 40 studies submitted with the over-the-counter (OTC) application. The FDA typically follows the recommendations of the scientific committees. These experts made clear that EC is safe and that it does not increase promiscuity or unprotected sex among teenaged women, nor does it cause women to abandon their regular birth control methods.

The Politicians:

White House spokesman Jim Morrell said the ruling was made by FDA scientists. "This was a decision made by career scientists at the FDA whose primary responsibility is to ensure that the public health is protected," Morrell said.

The FDA:

FDA officials could not immediately be reached for comment. In the past, agency officials have vowed the Plan B decision would be driven by science, not politics.

So the question is:

If everybody agrees the FDA should base its regulatory decisions on science, why didn't the agency approve OTC status for Plan B?

UPDATE: Plan B Approval Part I, II, Part IV.

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