FDA Comment Period on Application for OTC Plan B Ends
The 60-day public comment period on whether to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B expired on Tuesday with up to 10,000 comments submitted to FDA, the Washington Post reports.
FDA spokesperson Julie Zawisza said the agency will review the comments "and decide how to proceed," but the agency did not indicate when it might make a decision (Kaufman, Washington Post, 11/2).
FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription, citing inadequate data on Plan B use among girls under age 16. Barr submitted another application that would allow Plan B to be sold without a doctor's prescription only to women ages 17 and older.
Former FDA Commissioner Lester Crawford in August announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it (California Healthline, 10/14).
Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) on Tuesday submitted a petition signed by more than 9,800 supporters to acting FDA Commissioner Andrew von Eschenbach, saying the agency's delayed decision is "virtually unprecedented."
Murray urged the agency to make its decision "based on science and efficacy, not on public pressure" (Lumpkin, AP/San Francisco Chronicle, 11/1).
The Philadelphia Inquirer on Tuesday examined how media coverage of FDA's delayed decision has helped advocates' efforts to promote EC. The number of annual prescriptions for Plan B have doubled to 1.6 million during the two years since Barr first applied for nonprescription Plan B sales.
The application "has generated a ton of publicity, and that almost surely has a consequence of increasing awareness, and awareness is still the biggest barrier to use," James Trussell, a Princeton University economist and proponent of EC, said.
Some conservatives say that making Plan B available without a prescription would enable rapists to "cover up their abuse," expose women to medical problems and encourage increased "risky" sexual behavior, the Inquirer reports (McCullough, Philadelphia Inquirer, 11/1).