The American Medical Association House of Delegates on Monday during its annual meeting in Chicago approved a resolution opposing FDA's decision to deny Barr Laboratories' application for over-the-counter status for its emergency contraceptive Plan B, the AP/Las Vegas Sun reports (Burghart, AP/Las Vegas Sun, 6/15). FDA in May issued a "not approvable" letter to Barr, citing inadequate data on the use of Plan B among girls under age 16. The agency's decision was unusual because it contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B -- which can prevent pregnancy if taken within 72 hours of sexual intercourse -- be sold without a prescription. In addition, Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said he made the decision to reject the application on his own and did not follow the recommendations of his staff (Kaiser Daily Reproductive Health Report, 6/9). AMA delegates approved the resolution without debate after the measure received "wide support" at a committee meeting on Sunday, according to the AP/Sun (AP/Las Vegas Sun, 6/15). Dr. Ronald Davis, head of the AMA committee that considered the resolution, said that FDA's "own advisory committee determined emergency contraceptive pills were safe." He added that doctors could "pre-write" prescriptions for patients to make EC "more readily available and encourage ways to quickly respond to women who want it," Reuters reports (Reuters, 6/14).

Medical Students Support Resolution
The resolution was brought to the AMA House of Delegates by its medical student members, Reuters Health reports. Hilary Faerbrother, a third-year medical student at Emory University who spoke before the AMA House of Delegates committee considering the resolution, said that FDA's decision amounted to "unprecedented action that refutes evidence-based medicine and creates a politically driven barrier to safe, affordable and effective access" to EC. American College of Obstetricians and Gynecologists President Dr. Vivian Dickerson, who spoke in support of the resolution, said that allowing Plan B to be sold without a prescription could "reduce the number of abortions by as much as 50%." She called Galston's decision an "egregious abuse of power" and added that the AMA should take action "because we can't allow the FDA to be co-opted by politics" (Peck, Reuters Health, 6/14). Dickerson said, "The overwhelming data is that [Plan B] is safe, effective and usable across age groups" (AP/Las Vegas Sun, 6/15). AMA delegates also approved a resolution calling for the Bush administration to restore funding for United Nations family planning programs, Reuters reports (Reuters, 6/14).