Sean Patrick Maloney: “I am sure that the majority of this body agrees, like the expert panel and the FDA staff, that American women deserve…”

“I am sure that the majority of this body agrees, like the expert panel and the FDA staff, that American women deserve the most safe and effective contraceptives available. Supporting this amendment is a vote in support of healthy women and evidence-based science. A perfect example of inserting politics into science is the recent decision by the FDA to deny over-the-counter status to Plan B or the morning after pill. On December 16, 2003, a joint panel of the FDA's Reproductive Health Drugs Advisory Committee and Nonprescription Drugs Advisory Committee voted 28 to 0 that Plan B could be safely sold as an over-the-counter medication. It then voted 23 to 4 to recommend that the FDA approve the application to make Plan B available over the counter. Yet on May 6, 2004, the FDA rejected over-the-counter status for Plan B. The Washington Post, dated June 18, 2004, reported that a top agency scientist dismissed the reasoning that was used to justify the rejection as unfounded. Officials at FDA wrote that Acting Center Director Stephen Galson was introducing a different standard for evaluating Plan B than the FDA had applied to other contraceptives. Politics and ideology have been allowed to influence science, endangering the reputation of the FDA and having a direct and irreversible effect on the health and well-being of thousands of women. The Maloney-Waxman amendment ensures that the FDA will not deprive American women of safe and effective contraceptives on ideological grounds.”