FDA approves nonprescription sales of Plan B for women over age 18

FDA on Thursday approved Barr Laboratories’ application for nonprescription sales of its emergency contraceptive Plan B to women ages 18 and older, the Washington Post reports.

Women purchasing Plan B will be required to show proof of age, according to the Post (Kaufman/Stein, Washington Post, 8/24).

FDA in May 2004 issued a “not approvable” letter in response to an application originally submitted by the pharmaceutical company Women’s Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse.

Barr purchased Women’s Capital during consideration of the application. FDA in the “not approvable” letter cited inadequate data on its use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older.

Former FDA Commissioner Lester Crawford in August 2005 opened a 60-day public comment period on the application, saying that science supported approval of nonprescription Plan B access for women and girls ages 17 and older but that the application presented FDA “with many difficult and novel policy and regulatory issues,” including how to enforce an age restriction.

In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the “appropriate age” to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18.

The company and FDA officials on Friday said the application had been resubmitted to the agency (Kaiser Daily Women’s Health Policy Report, 8/22).

Approval Details

The approval requires Barr to “[m]onitor the effectiveness of the age restriction and the safe distribution of [nonprescription] Plan B to consumers [ages] 18 and above and prescription Plan B to women under 18,” according to an agency release (FDA release, 8/24).

The drug will be sold without a prescription at licensed pharmacies but will not be sold at gas stations or convenience stores, the AP/Yahoo! News reports.

Von Eschenbach in a memo clarifying the age restriction wrote that the company proved that nonprescription sales of Plan B are safe for women ages 18 and older and that pharmacies effectively can enforce the age restriction, adding that Barr did not prove that the girls ages 17 and younger could safely and effectively use the drug without having a physician’s prescription.

Barr has said it hopes to have the nonprescription drug on the market by the end of 2006 (Bridges, AP/Yahoo! News, 8/24).