Sunday, August 13, 2006

Plan B Week In Review

Reuters photo

On Thursday, we find out that the decision whether the FDA should approve OTC access to Plan B was made well before agency scientists finished their final review:

In a sworn statement in June, Dr. John Jenkins, director of the FDA's Office of New Drugs, said he learned in early 2004 that then-FDA Commissioner Mark McClellan had decided against approval before the staff could complete their analysis.

Plan B was rejected in May 2004, shortly after McClellan left the agency.

"I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins said in a deposition for a suit by the Center for Reproductive Rights that seeks easier access to Plan B. Jenkins later said he did not know if anyone outside FDA influenced the decision.

Another FDA official, who evaluated Plan B, alluded to White House involvement in a deposition given last month.

Dr. Florence Houn said she was also told that in January by Deputy Commissioner Dr. Janet Woodcock that Plan B needed to be rejected "to appease the administration's constituents" but that it could be approved later.

McClellan, who led the FDA when Barr submitted its application in 2003, said he gave updates to the White House as a matter of course but denied they told him what to do.

On Friday, Abby Wisse Schachter writes an op-ed about Plan B for the New York Post (and the Post publishes it!) and manages to get every single basic fact about Plan B wrong. I don't know if Ms. Wisse Schachter's problem is ignorance or malevolence. What I do know is that a lack of familiarity with the basics precludes an informed opinion.

Since there are so many inaccuracies in the op-ed (think "Liar, liar, pantalones on fire.") I will have to correct them in a separate post. In the interim, here's some homework for you: read the article and see how many mistakes you can find.

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