Bipartisan Action to Stop FDA from Postponing Morning-After Pill Decision

Nov 3, 2005
Press Release

WASHINGTON, DC - In the wake of repeated postponements by the Food and Drug Administration (FDA) on deciding Plan B emergency contraception's over-the-counter status, a bipartisan group of legislators has introduced legislation requiring a decision on Plan B (text of bill: . The legislation was introduced by Representatives Carolyn Maloney (D-NY), Christopher Shays (R-CT), Jay Inslee (D-WA) and Joe Crowley (D-NY), all members of the Congressional Pro-Choice Caucus.

"We're not telling the FDA how to decide on emergency contraceptive pills, but we do want the FDA to make a decision before stalling any longer," said Maloney. "It's time for Plan B on Plan B. It's no secret anymore that politics, not health concerns, is driving the FDA's process. The FDA exists to improve our health, not to play politics. The longer we have to wait for a decision on this clear-cut issue, the worse it is for women's health."

"The FDA has failed to take action on approving Plan B for over-the-counter status, despite scientific data that shows it would be safe," Shays said. "The FDA should make decisions based on science, not politics and ideology. The bottom line is, expanded access to emergency contraception will safely decrease the risk of unintended pregnancy and decrease the number of abortions."

"It's time to put an end to the FDA's heel dragging and excuse making on the Plan B application," said Inslee.

"The unnecessary delay in FDA passage of Plan B over the counter sales is yet another example of the assault on women's rights by the Bush Administration," Crowley said. "The Administration has dragged its feet throughout this entire process, putting politics ahead of public health policy. The facts are that Plan B is safe, Plan B is effective and Plan B is an essential tool in limiting the number of abortions and giving women the choices they deserve."

The legislation will require the FDA to approve or deny the over-the-counter application for Plan B, a concentrated dosage of birth control pills that, if taken within 72 hours of contraceptive failure or unprotected sex, can reduce a woman' risk of pregnancy by up to 89 percent. Failure to make a decision would result in automatic approval of OTC status. If the FDA determines the approval shouldn't stand they can act to deny the application -- but they would have to finally act.

The FDA has delayed the decision two years and recently postponed the decision indefinitely, despite stating, "the available scientific data are sufficient to support the safe use of Plan B as an OTC product...for women who are 17 years of age or older."