The Government Accountability Office today recommended in report GAO-07-54 that the Food and Drug Administration (FDA) should improve its oversight of direct to consumer prescription drug marketing. A Wall Street Journal article explains that the advertising media for prescription drugs widely vary.
GlaxoSmithKline PLC manufactures a genital herpes treatment called Valtrex, which is a billion dollar seller. According to the Wall Street Journal, while Glaxo does not market the drug to pregnant women and the drug is not FDA labelled for treatment of neonatal herpes, Glaxo is providing funding for doctors who speak at continuing medical education seminars on the benefits of screening all pregnant women for genital herpes.
What makes this interesting is that the Government does not support testing all pregnant women for genital herpes. To the contrary,
The CDC earlier this year said that “insufficient evidence exists to recommend routine” herpes screening of pregnant women, although it said testing should be offered to those whose sexual partners have the disease. A government-appointed panel of experts called the Preventive Services Task Force concluded last year that “there are no benefits associated with screening” asymptomatic women. It said, “The potential harm to many low-risk women and fetuses from the side effects of antiviral therapy may be great.”
The new Congress is expected to take up drug safety issues.