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Doctors See Politics in Morning-After Pill Delay
Published on Thursday, April 8, 2004 by Reuters
Doctors See Politics in Morning-After Pill Delay
by Lisa Richwine
 

WASHINGTON  - Political objections to wider access for a "morning-after pill" may result in restrictions that intimidate women from using the emergency contraceptive, according to an editorial published on Thursday in the New England Journal of Medicine.

The Food and Drug Administration in February announced it was postponing a decision on Barr Pharmaceuticals Inc.'s request to sell the contraceptive, called Plan B, over the counter. A ruling now is expected by May 21.

Plan B can prevent pregnancy when taken within 72 hours of sexual intercourse. Opponents of a switch, including several Republican lawmakers, argue easy access to the product may increase sexual promiscuity, particularly among teen-agers.

An FDA advisory panel of outside experts voted 23-4 last December to recommend making Plan B available without a prescription.

The agency's delay in making a final ruling "suggests that the FDA's decision-making process is being influenced by political considerations," said the editorial, written by the journal's editor, Jeffrey Drazen, and two members of the FDA advisory panel.

"The current delay ... may be followed by approval with restrictions on its over-the-counter sale that are designed to intimidate women who require access to this medication," the editorial said.

Limits that have been suggested include a minimum age requirement for purchasers, or putting the medicine "behind the counter" and making women ask a pharmacist for it.

"A treatment for any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly," the editorial said.

An FDA spokesman was not immediately available for comment. FDA officials in the past have insisted the decision will be based on science and not politics.

"There are ongoing discussions on many topics" with the FDA regarding Plan B, Barr spokeswoman Carol Cox said. She declined to provide specifics.

Plan B prevent pregnancy using higher doses of progestin, one of the hormones used in birth control bills.

Shares of Barr fell 79 cents, or 1.63 percent, to close at $47.60 on the New York Stock Exchange.

© Copyright Reuters Ltd2004.

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