Washington Post Examines ‘Controversy’ over Rx Drug Information Leaflets
The Washington Post health section today examines the "controversy" over prescription drug information leaflets, which "often contain the only detailed information consumers receive about the risks, benefits and side effects" of their prescriptions. A review released in mid-July by the FDA Drug Safety and Risk Management Advisory Committee found that the leaflets "omit important information and are often printed in such small type that they are nearly impossible to read." The committee recommended that consumer advocacy groups and medical and pharmacy organizations "hammer out" standards for "legible and consistent" prescription drug information and said that "[f]ailure to do so could lead to FDA regulation" of the leaflets. In the past, FDA efforts to standardize the leaflets have met "intense opposition" from doctors and pharmacists, and as a result, the agency has "left the content to private vendors," the Post reports. Larry Sasich, a pharmacist and spokesperson for the Health Research Group at Public Citizen, a consumer advocacy group, said, "The private sector has shown a consistent inability over the years to produce useful drug information." However, Carmen Cantizone, executive director of the National Association of Boards of Pharmacy, said, "If we force [private vendors] to standardize, some or all may say that there is no longer anything that distinguishes them from each other, and that will hurt their ability to market their product." She added that pharmaceutical companies could write and distribute the leaflets. Anne Trontell, director of the division of surveillance, research and communication support in the FDA Office of Drug Safety, said that the agency will decide whether to proceed with efforts to develop leaflet standards this fall (Lunzer Kritz, Washington Post, 8/13).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.