Friday, August 25, 2006

U.S. allows next-day pill's sale

U.S. allows next-day pill's sale
By Gardiner Harris
Copyright by The New York Times
Published: August 24, 2006

WASHINGTON The Food and Drug Administration approved over-the- counter sales of the "morning-after" contraceptive pill to women 18 and older on Thursday, resolving one of the most contentious issues in the agency's 100-year history.
The drug, an emergency contraceptive called Plan B that is manufactured by Barr Laboratories, will be sold only in pharmacies and health clinics. To buy it, women will have to show proof of age. Girls under age 18 will still need a prescription to get the drug.

Plan B is sold only in the United States and Canada. But similar drugs are available over the counter in India, Norway, Sweden and the Netherlands and can be bought in pharmacies without a prescription in several dozen other nations, including Australia, New Zealand and about 11 European nations, according to an online database maintained at Princeton University.
The acting commissioner of the Food and Drug Administration, Andrew von Eschenbach, said in a memorandum released Thursday that 18 was the appropriate cut-off age for sales because pharmacies already restrict nicotine and cold medicines that way.

The agency has decided to rely on voluntary compliance, since neither federal drug regulators nor Barr plans to police the age restriction.

A memorandum by Steven Galson, director of the agency's drug center, said that Barr should send to state pharmacy boards any reports of pharmacists who repeatedly sell Plan B to minors.

Barr has agreed not to sell Plan B at gas stations or convenience stores.

Anti-abortion groups strongly opposed Barr's application to switch the medicine from prescription to over-the- counter status, saying that it is an abortion pill whose widespread availability could lead to an increase in sexually transmitted diseases.

Abortion rights advocates pushed equally hard to get the application approved, contending that easy access to Plan B would sharply reduce the nearly one million abortions performed each year in the United States.

Both sides are wrong, studies suggest. Couples in the United States have so much unprotected sex - half of all pregnancies are unplanned - that even if the pills were widely distributed, they would be unlikely to cause a major change in abortion and disease rates.

In a press briefing on Monday, President George W. Bush was asked whether he supported von Eschenbach's intention to approve over-the-counter sales of Plan B. Bush said minors should need a prescription to obtain Plan B, adding, "I support Andy's decision."

Confusion about the medicine is widespread. Many women's health clinics pass out cards explaining the difference between Plan B, a contraceptive, and RU-486, the abortion drug.

Plan B is made from a synthetic hormone found in regular oral contraceptives. It should be taken within 72 hours of unprotected sex, and it generally acts by preventing ovulation or fertilization.

Plan B may in rare circumstances prevent a fertilized egg from becoming implanted - something abortion opponents decry. RU-486, on the other hand, causes a woman to miscarry a well-established pregnancy.


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