NEW BILL WOULD FORCE FDA TO REVISIT “MORNING-AFTER PILL” DECISION

May 12, 2004
Press Release

WASHINGTON, DC - Legislation to revisit and potentially reverse the FDA’s decision not to make the Plan B® contraceptive, or “Morning-After Pill, available over-the-counter (OTC) was announced today by Rep. Carolyn Maloney (NY-14) and has already been joined by four of her colleagues. 30 days after enactment of the legislation, the FDA Commissioner would be required to review his Plan B® decision and affirm that it is not based on politics, that it is based on sound science and that it conformed to FDA precedent. Maloney plans to introduce the legislation on Thursday.

FDA’s decision process has been called into question since its own scientific panel voted 23-4 in favor of granting OTC for Plan B®. Maloney announced the legislation at a press conference today.

“When a scientific panel votes 23-4 in favor of over-the-counter status but the FDA goes the other way, there has to be something at work other than science,” said Maloney. “No one should object to this bill. If politics indeed didn’t influence the decision, they should affirm that without fear.

“But if Bush Administration politics was the driving force behind the FDA’s decision, as we believe, the public needs to know. Everything the FDA does is a matter of public health and should strictly be based on science. Anything short of that is bad for the health of Americans and, in this case, American women.”

In January, Maloney and 75 of her colleagues wrote then-FDA Commissioner McClellan, urging him to heed the scientific panel’s recommendation for OTC status (Text of letter).
On December 16, 2003 a joint panel of the FDA’s Reproductive Health Drugs Advisory Committee and Non-prescription Drugs Advisory Committee voted 27-0 that Plan B® could be safely sold as an over-the-counter medication and then voted 23-4 to recommend that the FDA approve the application to make Plan B® available OTC.

Already joining Maloney on the bill are: Rep. John Conyers (MI-14), Rep. Joseph Crowley (NY-07), Rep. Lois Capps (CA-23), and Rep. Raúl M. Grijalva (AZ-07).

Summary of legislation:
30 days after enactment of the legislation, the FDA Commissioner would have to review his prior decision on Plan B® and affirm 1) that his decision was not politically influenced, 2) that it was based on sound science, and 3) that it conformed to FDA precedent and procedures. He must affirm these items, under penalty of law.

Facts about Emergency Contraceptive Pill (ECP):
Plan B® does not cause abortion, but instead prevents pregnancy if taken shortly after unprotected sex. The pill prevents inhibits ovulation, fertilization or implantation. If taken within 24 hours of unprotected sex, it can prevent 95% of pregnancies, or 89% if taken within 72 hours.

Nearly half of pregnancies in the United States are unintended, a number that could be cut in half with over-the-counter emergency contraceptive pills (ECPs). They are also expected to have a significant impact on health care costs - the New York State Comptroller recently released a report stating that the state of New York could trim nearly half a billion dollars from its health care expenditures if ECPs were widely available.

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