Plan B: Waxman wants House hearings

Medical Marketing and Media, Jan 2006 by Dickinson, James G

REP. HENRY Waxman (D-CA) has asked that the House Government Reform Committee to hold hearings on the manipulation of science for political purposes by the Bush administration, especially as it pertains to the PDA's decision not to approve OTC status for Barr Laboratories' Plan B emergency contraceptive.

In a letter to committee chairman Tom Davis (R-VA), Waxman reviewed findings in a Government Accountability Office (GAO) report that found "unusual" the high FDA management involvement in the Plan B decision, and noted particularly that all FDA managers who normally would sign off on such a decision were opposed to it and did not sign off.

The FDA says it disagrees with the GAO finding that high-level agency management was more involved in the decision not to permit an OTC switch for the Plan B emergency contraceptive than usual. The agency also didn't agree with the GAO's conclusion that the rationale presented by then-acting director of drugs Steven Galson for denying the application was novel.

Meanwhile the CBS News program 60 Minutes on November 27 reported that a single physician's fear that the Plan B "morning after" contraceptive would promote underage teen sex may have governed the PDA's controversial decision.

The physician, former FDA Reproductive Health Drugs Advisory Committee member W. David Hager, an evangelical Christian ob-gyn practitioner in Lexington,Ky.,wrotea"minority report" to the FDA in terms later used by Galson in his Plan B approval denial.

Hager told 60 Minutes, "I was concerned about 10-, 11-, 12year-old girls buying this product."-J.G.D.