Senators Ask for Results of Investigation on FDA Delay of Plan B Decision
Thirteen senators have urged the Government Accountability Office to release findings from its ongoing investigation into FDA's indefinite postponement of a decision regarding Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 17 and older, CQ HealthBeat reports. Twelve Senate Democrats and Independent Sen. Jim Jeffords (Vt.) made the request following the resignation of FDA Assistant Commissioner for Women's Health Susan Wood, who stepped down last week after the agency's announcement of the delay.
"The turn of events leaves the strong impression that concerns about politics have overridden concerns about public health in this process," the senators wrote.
GAO said it is nearing completion of its investigation and will release the findings to the senators soon. The office launched the investigation in June at the request of the senators (CQ HealthBeat, 9/6).
The Washington Post on Tuesday examined the debate generated by FDA's action to delay a decision on Barr's application. Opponents name safety issues as a concern against allowing nonprescription sales of EC, citing a lack of research that shows it is safe for use by adolescents.
However, several "mainstream" medical groups -- including the American Medical Association and the American Academy of Pediatrics -- have voiced their support for Plan B, saying that it is both safe and effective, according to the Post. The American College of Obstetricians and Gynecologists estimates that if EC were widely available without a prescription, it could prevent about two million pregnancies and about 500,000 abortions annually (Payne, Washington Post, 9/6).
The Chicago Tribune on Wednesday featured an interview with Wood, in which she discusses her resignation from FDA and her thoughts on the agency's action regarding Plan B.
According to Wood, the delay "is not technically a denial, but by going off on this particular issue of teens and separate prescription status and nonprescription status, ... you're essentially denying access to all women of all ages to this product when it's most effective, which is immediately." She added, "In my mind, it's a denial to all women to something that could prevent unintended pregnancies and ultimately abortion" (Neumer Lara, Chicago Tribune, 9/7).