FDA gives OK to over-the-counter Plan B

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

By Victoria Stagg Elliott, AMNews staff. Sept. 11, 2006.

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.