'Morning-After Pill' still no decision by FDA

Nov 2 2005

At the end of the two-month comment period on the "morning-after pill" Plan B, there is no indication when or how the Food and Drug Administration will proceed with the controversial application.

Plan B was originally to be made available to women without a prescription but in a cooling off period as many as 10,000 comments have apparently been submitted for and against the drug.

According to FDA spokeswoman Julie Zawisza, the agency's next step will depend on the comments; she says they will be read and a decision made on how to proceed.

This unusual handling of the Plan B application, which is now going through its third FDA review, has angered advocates of the emergency contraceptive.

Senators Hillary Clinton and Patty Murray said yesterday that they have helped collect 10,000 signatures on a petition calling on the FDA to act promptly on the Plan B application.

But many social conservatives have lauded the latest review, which allows a different level of public involvement.

The Plan B application was overwhelmingly recommended by an agency advisory panel in December 2003 and was embraced by most of the agency's science staff.

But top agency officials then ruled against the application.

According to the Commissioner at that time, Lester M. Crawford, the agency did not have the authority to approve the application because it contained a provision allowing women older than 18 to buy the contraceptive over the counter while younger girls would need a prescription.

Senator Murray has reportedly said she is "stunned" by the agency's actions on Plan B, and says the FDA has the responsibility to make scientific decisions and to ask for public comment is 'bizarre'.

According to Hillary Clinton a reluctance to make a formal decision on the part of the FDA is "slow-walking" the whole issue.

She says that a decision based on science would be an approval, but political allies do not want to see that happen, and it is of concern to her that the FDA is subject to this type of politics.

However Wendy Wright, the executive vice president of Concerned Women for America, which opposes the expanded use of Plan B, says her group has submitted 30 pages of comments on regulatory, legal, medical and societal issues related to the contraceptive.

Plan B is made by Barr Pharmaceuticals Inc.