Print

Email story

Comment

Email editor

FDA again in hot seat over morning-after pill

The FDA is weighing offering this pill without a prescription.

WASHINGTON - The government is considering whether to make morning-after birth control available without a prescription, and like most issues that involve sex and pregnancy, it has generated heated debate.

Fierce arguments have gone on inside and outside the Food and Drug Administration, which may decide as soon as this week whether drug stores can sell the emergency contraception known as Plan B without a prescription to women age 16 and older.

Each side accuses the other of manipulating science for political purpose. Plan B backers say the pill is a safe way to prevent thousands of unwanted pregnancies and the abortions that may follow. Making the contraception available over the counter, they say, is crucial for women who might need the protection over a weekend or when it is difficult to obtain a prescription.

Plan B can prevent pregnancy for up to 72 hours after sex. The sooner the pill is taken, the more effective it is.

"Women's reproductive rights shouldn't hinge on someone else's schedule. We should have this at our fingertips. It should be next to condoms in drug stores," said Kelly Mangan, 22, president of the University of Florida's chapter of the National Organization for Women. She was arrested this month in a protest outside the FDA's headquarters in suburban Maryland.

Opponents worry that the drug encourages women - teenagers in particular - to have risky sex. If over-the-counter sales are permitted, older teenagers or adults might buy the pills for some of their younger friends or their sexual partners, critics say.

"What we're concerned about is a number of young people who are not engaged in sexual activity who feel tremendous pressure, and this will only add to the pressure that is on them," said Wendy Wright of Concerned Women of America, a conservative group that focuses on social issues.

Not contested, by either side, is that the drug is safe or effective. Some FDA staffers believed questions about sexual behavior were overwhelming scientific ones, according to an internal agency memo written last year.

Last May, the FDA rejected nonprescription sales of emergency contraception, against the overwhelming recommendation of the agency's own scientific advisers. The FDA said it worried that there was not enough data about the pill's use by young teens. The agency promised to reconsider if the pill's manufacturer, Barr Laboratories of Pomona, N.Y., figured out how to sell over the counter only to those 16 and older.

In July, Barr again applied for approval. The company now proposes drugstores check customers' ages to be certain buyers are at least 16, an approach the FDA has not approved before.

[Last modified January 17, 2005, 01:06:09]