Monday, November 29, 2010

The Over-the-Counter Emergency Contraception Saga, Or Why Medicine and Politics Do Not Mix

Q: Guess who is suing the FDA and why?

A: The Center for Reproductive Rights over the FDA's refusal to make emergency contraception (EC) available over-the-counter to women of all ages.

***Note: When you read any of the included links, replace "Plan B" with "Plan B One-Step". Plan B, a 2 pill brand, is no longer manufactured and it's been replaced with Plan B One-Step, a 1 pill brand.***

For more than a year and a half, the FDA and the Obama Administration has ignored a court order to reconsider its refusal to make emergency contraception (EC) available over-the-counter to women of all ages. The Center has given the FDA ample time to end its baseless restrictions, but as of today it has not taken any steps to comply with the court order—most recently saying it will wait to review a new application from the manufacturer that may or may not be filed at some unspecified time in the future.

The Center is now taking the FDA back to court and are calling on supporters to write the FDA Commissioner to take immediate action to end restrictions on emergency contraception.

At the start of his administration, President Obama declared that politics would no longer play a role in U.S. science policy, stating, "we make scientific decisions based on facts, not ideology." And soon after FDA Commissioner Margaret Hamburg was confirmed, she told reporters that it was her mantra to make FDA's decisions more "science-based."

So in March 2009, when the court ruled that the FDA acted in "bad faith and in response to political pressure" when it repeatedly and unreasonably delayed making a decision on Plan B and departed in significant ways from its normal procedures, it thought the new administration would "conduct a fair assessment of the scientific evidence." This has obviously not happened, and the Center is returning to the courts to make sure the FDA complies with medical and scientific consensus that says there is no rationale for age restrictions to emergency contraception.

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