FDA OKs OTC Sales of Plan B to Women 18 and Older

The FDA has approved OTC sales of levonorgestrel tablets, also known as Plan B, for emergency contraception, according to an Aug. 24 press release from the agency. The contraceptive will only be available without a prescription to women 18 and older, according to the release.

"I think this FDA action essentially satisfies what the Academy was asking for" when the AAFP Congress of Delegates in 2003 called for OTC status for a progesterone-only emergency contraceptive, says AAFP President Larry Fields, M.D., of Ashland, Ky.

The 2003 Congress of Delegates' action (Members Only; scroll to Resolution 515; PDF file: 19 pages / 148 KB. More about PDF files.) followed lengthy debate in a reference committee but passed after no debate on the floor of the Congress.

The 2003 AAFP Congress called for labeling "that includes information on the mechanisms of action and that encourages patients to contact their primary care physician for support and/or counseling (… and that includes) information on safe sexual practices and contraception." The FDA news release says Duramed Pharmaceuticals Inc., a subsidiary of Barr Pharmaceuticals Inc., "will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program."

The FDA is restricting Plan B's distribution to licensed pharmacies and clinics, and it requires the medicine to be stocked behind the counter so staff can check a buyer's proof of age or take a prescription. "The limits the FDA put on the product are not major obstacles to obtaining the drug," says Fields.

The 2003 debate during the hearing of the Reference Committee on Public Policy included opposition to OTC status for emergency contraceptives. "Opponents … stated their concern about potential interference with the physician-patient relationship, were emergency contraception to be available over-the-counter; … the divisiveness of the issue for the Academy and a related worry that support … might lead to a change in the Academy's neutral position on abortion," say the Transactions of the 2003 Annual Session of the Congress of Delegates.

The FDA's decision to allow consumers to obtain Plan B without a prescription "will be helpful to some patients," says Hugh Taylor, M.D., of Hamilton, Mass., a delegate to the AAFP Congress for 2004-08. Taylor was an alternate delegate to the AAFP Congress in 2003 when he defended the safety record of progesterone-only contraception. "Plan B is one of several options women will have to help control their reproductive health," says Taylor. "And this medication will help to reduce the number of abortions women obtain to avoid unwanted pregnancies."

For women under 18, "nothing has changed, and they will be able to obtain this medication with a call to their family physician," says Taylor. "Many of my colleagues have been in the habit of giving women a prescription for this contraceptive so they will have it when needed, and we all try to make ourselves available to women" who may need an emergency contraceptive, he adds.

On a related topic, a 2002 AAFP policy supports provision of or referral for rape-related services, such as emergency contraception; counseling to decrease post-traumatic stress disorder; and treatment to prevent STDs, including HIV and AIDS. "FDA's action on Plan B is in line with this policy," says Fields.

In "Plan B: Questions and Answers," the FDA provides more information and encourages people to contact Duramed at (800) 330-1271 with questions. In addition, the FDA's background materials include the agency's Aug. 24 approval letter, which traces the three-year history of requests for OTC status for Plan B, and labeling information, which contains extensive product information.