Gynecologists back nonprescription sales

Under political pressure, the FDA asked for more details on use among teens.
KNIGHT RIDDER NEWSPAPERS
PHILADELPHIA -- The leading organization of U.S. obstetricians and gynecologists urged federal regulators to resist conservative political pressure and approve nonprescription sales of so-called morning-after pills.
A Food and Drug Administration advisory panel overwhelmingly recommended in December that Plan B, a brand of emergency contraception, be sold over the counter, and the FDA usually follows such guidance. But amid intense pressure from conservative politicians, the agency asked manufacturer Barr Laboratories for more information about teenagers who have used the pills, and postponed a decision from February to this month.
Four prominent physicians from the 46,000-member American College of Obstetricians and Gynecologists held a news conference Tuesday to decry the delay. ACOG is holding its annual meeting at the Pennsylvania Convention Center.
"Plan B is safe and effective," said incoming ACOG president Vivian M. Dickerson, director of obstetrics and gynecology at the University of California, Irvine. "It has no potential for overdose or addiction. ... It is easy to use. ... By preventing unintended pregnancy, it also prevents abortion.
"We strongly believe," she said, "there is a public-health imperative to increase access to emergency contraception. ... We urge the FDA not to succumb to political pressure."
Previous pleas
The same plea was made last month in an editorial in the New England Journal of Medicine. The journal editor and two FDA advisers urged the FDA not to try to appease critics by approving nonprescription sales with restrictions such as a minimum-age requirement, or behind-the-counter product placement.
An FDA representative said Tuesday the agency could not comment on the status of the Plan B application.
Barr Laboratories spokeswoman Carol Cox said the company had discussed possible compromises with the FDA and expected "some sort of decision" by May 21, the deadline for the FDA to rule.
"If we could come to some compromise for younger adolescents, I think we would be open to that if we could get approval for over-the-counter status," she said.
Emergency contraception, which contains the same hormones as regular birth-control pills, is about 89 percent effective in preventing pregnancy after sex if taken within 72 hours of intercourse. But surveys show many women have difficulty obtaining emergency contraception within 72 hours, either because they cannot get a prescription in time, or because many pharmacies do not stock the product, or both.
The method is available without a prescription in 33 countries. Five U.S. states have programs that make the pills available directly from pharmacists.
Opponents of over-the-counter availability -- including 49 members of Congress who wrote a letter to President Bush -- contend it could lead to more promiscuity and sexually transmitted diseases, especially among adolescents.