Over (and Behind) the Counter
A deal is struck on selling the 'morning-after pill'-and a new FDA chief
A woman whose regular birth control method failed or who was raped will not be the first person to benefit from last week's decision to sell emergency contraceptive pills without a prescription. The immediate beneficiary will most likely be a man.
Andrew von Eschenbach, the acting head of the Food and Drug Administration, which approved the pill, should get the job for real in September, because key senators dropped their opposition to his nomination when he dropped his opposition to the "morning-after pill," called Plan B. "All he needs now is a simple majority vote for approval," says one of those senators, Democrat Patty Murray of Washington State. And that's good for the drug agency, which has been without a permanent leader for nearly a year.
Proof of age. Women will first see Plan B without a prescription near year's end-it has been prescription-only since 1999-after the manufacturer, Barr Laboratories, packs it in new boxes with more drug facts in easy-to-read language, like other nonprescription drugs. The estimated price is between $20 and $40 for a pack of two pills. And it won't be in gas stations or convenience stores but tucked behind the pharmacy counter, where buyers will have to show a valid ID to a pharmacist proving that they are at least 18 years of age. These restrictions are all part of the deal the FDA and the drug maker cut to market Plan B. The drug has been mired in controversy since the FDA refused to approve easier access two years ago, overruling the agency's own scientific advisers amid charges that it had caved in to conservatives who equate the pill with abortion. (Plan B contains hormones that prevent fertilization or stop a fertilized egg from implanting in the uterus.)
Conservative groups condemned the expanded access, charging that it cuts parents out of the loop. But keeping the pill behind the counter, along with the age restriction, didn't please women's health advocates either. "'Behind the counter' is another barrier," says Amy Middleman, a pediatrician and adolescent-health specialist at Texas Children's Hospital in Houston. "Adolescents make a mistake or they get raped, and they may not have the self-confidence to share personal information with a pharmacist." IDs, after all, show not just age but name and address. Canadian pharmacists were caught last year collecting this information. "Plan B has to be used within 72 hours to be effective. You don't want to create reluctance to use it," she says. Murray agrees but says "at least women don't have to find a doctor, get a prescription, find a pharmacy, and wait to get it filled now."
The drug agency says it insisted on the distribution limit to ensure that buyers could get health counseling from a pharmacist and on the age limit because there were doubts about the ability of younger teens to use the pill responsibly. "Ridiculous," says James Trussell, a reproductive-health researcher at Princeton and a member of the FDA's advisory committee on the drug. "We saw at least three studies showing that younger teens used the drug just as safely as older women did. Plan B is safer than aspirin." Medically, perhaps, but politically it clearly has a big warning label.
This story appears in the September 5, 2006 print edition of U.S. News & World Report.
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