Lawmakers Call on HHS to Probe Reports of Plan B Memo

Two Democratic senators have asked HHS Secretary Michael Leavitt to launch an investigation into reports that a conservative member of an FDA advisory committee was asked to write a "minority report" explaining why the agency should reject OTC status for the emergency contraceptive Plan B.

Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) said a memo written by David Hager, a physician appointed by President Bush to the FDA Advisory Committee for Reproductive Health Drugs, raises new concerns that the FDA' decisionmaking process is being driven by ideology over science.

Hager was one of only four FDA advisers in December 2003 to vote against recommending OTC status for Plan B (levonorgestrel), which prevents pregnancy after sexual intercourse. Despite the 23-4 favorable vote, the FDA in May 2004 rejected the application submitted by Barr Laboratories. Barr resubmitted its OTC application in July 2004 with a revised marketing strategy. The application is still pending, despite the passage of a January 2005 deadline under the Prescription Drug User Fee Act.

According to reports in The Washington Post and The Nation, Hager was asked to write a memo after the advisory panel vote, Clinton and Murray noted in their recent letter to Leavitt. "If substantiated, these allegations seem to leave little doubt that the process for considering Barr Laboratories' application was based not on science, but on personal beliefs," Clinton and Murray noted.