A memo from interim FDA commissioner Dr. Andrew von Eschenbach informed Plan B manufacturer Barr Pharmaceuticals Inc. that they would still be able to sell the drug to girls 17 and younger with a prescription, noting there was too little evidence suggesting that young teens could safely use the drug without a doctor's supervision.
Under this plan, the drug would be available without a prescription at pharmacies where a pharmacist can verify the buyer's age, but would not be sold in places such as convenience stores. Plan B should be available for purchase by the end of the year.
Meanwhile, Barr has agreed to make plans to track pharmacists' compliance with the age restriction -- through methods such as anonymous shoppers -- at least twice in the first year, and once every subsequent year. Any stores that fail to adhere to the rule will be reported to their respective state pharmacy licensing board.
"This approach should help ensure safe and effective use of the product," von Eschenbach concluded.
"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," said Bruce L. Downey, Barr's chairman. However, the company pledged to continue to pursue an unconditional over-the-counter classification for their drug in the future, and announced a national campaign for women and their health providers designed to educate them about, and raise their awareness of, emergency contraception.
Much of the resistance against the Plan B drug comes from opponents who claim easy availability of the drug would encourage sexual promiscuity among women. Wendy Wright, president of Concerned Women for America, feared that wider availability of Plan B -- which is not as effective as proper use of regular birth control -- could lure women into a false sense of security about unprotected sex.
Plan B works by delivering a concentrated dose of the drug found in most conventional birth control pills, lowering the risk of pregnancy by 89 percent if taken within 72 hours of unprotected sex. If a woman is already pregnant, the pill has no effect.
The FDA's scientists overwhelmingly approved Plan B for sales without a prescription in 2003, when the proposal first came before the administration. However, high-ranking FDA officials rejected the decision because they were concerned about young teens using the pill without doctor supervision. Barr responded by requesting the drug be made available over-the-counter to women 16 and older, but the FDA postponed their decision indefinitely, prompting Dr. Susan Wood to resign as the FDA's women's health chief in protest.
"While I am glad that the drumbeat for a return to a science-based FDA has had some positive impact," she said, "this decision still represents a compromise, one that could have the unintended consequence of hurting young women's health."
"The FDA no longer makes decisions based on science," added Mike Adams, a consumer health advocate and critic of the FDA. "The overriding factors for all FDA decisions are now politics and the protection of industry. The agency's politically-motivated foot dragging on Plan B demonstrates this quite clearly."
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