FDA Expected To Announce Review of Direct-to-Consumer Prescription Drug Advertisements
FDA as early as Tuesday plans to announce a review of direct-to-consumer prescription drug advertisements, the Wall Street Journal reports. FDA and the pharmaceutical industry are facing pressure to alter advertising practices for drugs, with agency research showing that many physicians and consumers think drug ads exaggerate benefits and do not adequately disclose risks.
FDA's last broad review of pharmaceutical industry advertising led to revised guidelines in 1997 that "set off a surge in ads," the Journal reports. The agency is expected to announce that it will hold a public meeting to gather information and opinions about DTC drug ads, according to people with information on the issue. Such sessions typically "serve as the first formal step in setting new rules," according to the Journal.
FDA is likely to consider "whether drug advertisements provide balanced information about the risks and benefits of specific medications" and will "probably ask whether it needs to adjust the current requirements for disclosure of drugs' side effects," the Journal reports. The review might encompass promotions of medical devices as well. The agency also might review advertising in digital media.
Approval from Congress likely would be necessary for FDA to be able to require drug makers to submit their advertisements for scrutiny or to establish a moratorium on advertisements for new products, the Journal reports.
In related news, the Pharmaceutical Research and Manufacturers of America on Tuesday is scheduled to announce voluntary drug advertising guidelines (Wilde Mathews, Wall Street Journal, 8/2).