Barr Laboratories and FDA officials on Friday said the company has resubmitted to the agency an application to provide nonprescription access to its emergency contraceptive Plan B, Reuters reports (Reuters, 8/18). 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 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 letter also requested that Barr make unspecified changes to Plan B packaging and provide a thorough description of the company's plan to enforce the age restriction. The letter says, "If after our discussions we conclude (your) program isn't sufficiently rigorous, ... Plan B will remain [prescription]-only for women of all ages." The company and FDA officials earlier this month met in Washington, D.C., to discuss the application. Barr on Aug. 10 announced that it will amend the age restriction in its application but that it cannot be accountable for pharmacies that do not abide by the restrictions (Kaiser Daily Women's Health Policy Report, 8/16). Barr did not disclose the contents of its resubmitted application. FDA spokesperson Susan Bro did not say when the agency would decide on the application but added that FDA "remain[s] committed to an expeditious review" (AP/Columbus Dispatch, 8/19).

Related Letter to Editor
FDA's delay on Barr's application is a "major issue" because the agency "depart[ed] from past practice to make a decision on the basis of politics and not science," James Trussell, director of the Office of Population Research at Princeton University, and Association of Reproductive Health Professionals President Wayne Shields, write in a Wall Street Journal letter to the editor in response to an Aug. 4 Journal editorial (Trussell/Shields, Wall Street Journal, 8/21). The editorial says that Senate Health, Education, Labor and Pensions Committee Chair Mike Enzi (R-Wyo.) should highlight "the deadly serious consequences" of holding up von Eschenbach's nomination to permanently head the agency to discuss "minor issues" such as the Plan B application (Kaiser Daily Women's Health Policy Report, 8/4). Trussell and Shields write that the application is "minor only to those who have not followed the absurdity of the FDA's actions, or inactions," on the applications, adding that EC access is a "major issue for women who experience a broken condom, are raped or have unprotected sex for any reason, thus facing a potential unintended pregnancy." The authors conclude that while von Eschenbach "has had very little to do with the past decisions" on Barr's Plan B applications, "he is now in the enviable position to take a more positive step" (Wall Street Journal, 8/21).