Plan B
Tuesday, January 18, 2005; Page A16
LAST MAY, WHEN the Food and Drug Administration decided not to allow pharmacies to sell the emergency contraceptive Plan B over the counter, we wrote that the FDA was within its rights to be cautious. The agency had overridden the advice of a panel of its own experts, who pointed out that the drug is considered safe and that if taken quickly (within 72 hours of intercourse) Plan B effectively prevents unwanted pregnancies -- and therefore unwanted abortions -- both of which are good arguments for over-the-counter sales. But FDA officials were bothered by the absence of data describing the drug's impact on girls who would, if Plan B required no prescription, no longer need a doctor's approval to get it. Because recent research has shown that many drugs can affect adolescents differently than adults, this was a legitimate concern.
Other advocates in the Plan B debate had different motivations. Most of the time the drug works by preventing ovulation, and therefore conception, but it may also prevent fertilized eggs from being implanted in the uterus. For that reason the drug has attracted political opponents who call it an "abortion pill," as well as political supporters, such as the Public Interest Media Group, who argue that requiring a prescription for Plan B constitutes an "arcane, medically unjustified barrier to back-up birth control." Opponents of the drug have also said it will increase sexual profligacy, a claim that was soundly rebutted this month by a study published in the Journal of the American Medical Association; it showed that the availability of Plan B does not alter women's sexual behavior and does not lead to an increase in sexually transmitted diseases (though it does not, interestingly, necessarily reduce rates of pregnancy either). Supporters of the drug have picketed the offices of the FDA. Instead of a reasonable debate about adolescent use of the drug, in other words, the argument has deteriorated into a mudslinging match about the politicization of science and the alleged influence of the White House and religious fundamentalists on the FDA.
There is a way out of this political snarl: Barr Pharmaceuticals Inc., the company that makes Plan B, has submitted a new application to the FDA, once again asking for permission to make Plan B available without prescription but this time restricting availability to girls younger than 16. The company proposes to sell the drug from behind the pharmacist's counter, so that age restrictions will be more easily enforced. If FDA officials really meant it when they said that their concerns were solely focused on young teenagers, then they should take this new application seriously and proceed to allow sales of the drug, over the counter, to adults.
link
http://www.washingtonpost.com/wp-dyn/articles/A16728-2005Jan17.html?referrer=email