Nonprescription Sales of Contraceptive Approved
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 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 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 science supported approval of nonprescription Plan B access for women and girls ages 17 and older, but 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, 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 letter also requested that Barr meet with FDA within seven days, make unspecified changes to the packaging for Plan B and provide a thorough description of the company's plan to enforce the age restriction (California Healthline, 8/18).
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 Barr proved nonprescription sales of Plan B is safe for women ages 18 and older and that pharmacies effectively can enforce the age restriction, adding that the company did not prove adolescents ages 17 and younger could safely and effectively use the drug without the supervision of someone licensed to administer it.
Barr has said it hopes to have the nonprescription drug on the market by the end of 2006 (Bridges, AP/Yahoo! News, 8/24).