Health

FDA gives OK to over-the-counter Plan B

Age restrictions will be applied to the drug's purchase.

By Victoria Stagg Elliott — Posted Sept. 11, 2006

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Nearly three years after two Food and Drug Administration advisory committees recommended that emergency contraception be available over the counter, the agency has approved the switch with certain restrictions.

Plan B, also known as the morning-after pill, will be available from pharmacists, without a prescription, to women 18 and older. A prescription will still be required for those younger. Duramed Pharmaceuticals, the product's distributor and a subsidiary of Barr Pharmaceuticals, has agreed to educate health care professionals and consumers about appropriate use. The company also will set up a toll-free hotline to answer questions, monitor the effectiveness of the age restriction and ensure that the drug is available only through clinics and pharmacies.

"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 chair and CEO.

Debate about this step has been controversial. Because it is unusual for the agency to take so long to act on an advisory committee recommendation, the timeline prompted some women's health activists to accuse the agency of unreasonably delaying its final decision because of politics.

Most major medical societies, including the American Medical Association, support the switch because it would allow more women to access the medication during the 72-hour time window when it is most effective.

"The [AMA] applauds the recent FDA approval of Plan B emergency oral contraceptive as an over-the-counter option," said AMA Trustee Joseph M. Heyman, MD.

Reproductive rights organizations also have promoted OTC status and greater access as a way to reduce unintended pregnancies and abortion.

"This is a historic event in the struggle for women's reproductive health and rights," said Sharon L. Camp, PhD, president and CEO of the Guttmacher Institute.

But opponents lobbied against the status change because they say using the medication can be a form of abortion. They also expressed concerns that repeated long-term use may not be good for women's health. Additionally, some physicians opposed the shift because they say it will result in lost opportunities to provide medical care.

"Removing this high dose of hormones from a doctor's oversight removes a vital safety protection [for] women," said David Stevens, MD, executive director of the Christian Medical Assn.

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