Washington Post Examines Notification Policies for Drug Company-Initiated Recalls

Drug manufacturers initiate approximately 400 recalls each year, but whether people are aware of them "depends largely on manufacturers' and retailers' diligence, consumer vigilance and media cooperation," the Washington Post reports. In general, recalls involve a small subset of a specific product, whereas withdrawals are based on "fundamental problems that lead the FDA or a manufacturer to take a drug off the market." The FDA categorizes recalls into three classes, the most serious of which is Class I. Each year, there are approximately 15 Class I recalls, those that involve problems that can be life-threatening. Class II recalls are based on "errors that could exacerbate the drug's side effects or diminish its effectiveness," and the FDA issues about 250 such recalls each year. Class III recalls involve problems that are unlikely to cause health consequences, and there are about 125 Class III recalls annually.

With the exception of Class I recalls, the FDA has no regulations for notifying customers and only requires drug makers to develop a plan for recalls, according to David Bloch, a food and drug lawyer with the Washington, D.C.-based firm Reed and Smith. According to the Post, with so "few specific steps" from the FDA about how to alert health care professionals and consumers, many are "uninformed." In general, recalls are officially announced by the FDA in weekly "Enforcement Reports" on its Web site; only Class I recalls appear on the agency's home page. In addition, drug makers will alert health care providers by mail, but the messages are often "indistinguishable" from other manufacturer mailings and can therefore remain unopened, according to Susan Winckler, vice president for policy at the American Pharmaceutical Association. To address the issue, some experts are pushing for providers to adopt electronic record-keeping systems, which could help "spee[d] patient notification," the Post reports (Lunzer Kritz, Washington Post, 10/22).

In related news, USA Today examines the issues surrounding recall notification for implanted medical devices, including pacemakers, artificial knees and hips, heart valves and breast implants. Under current law, out of about 240 types of implantable devices, only the 12 "most high-risk" must be tracked by manufacturers, and even for those monitored, there are no provisions for patient notification. University of Buffalo professor of biomaterials Robert Baier said, "If you are the third owner of a Chevy, and they discover something wrong with the brakes, you get a recall notice. You don't get that with [these] devices." To address the problem, some experts are calling for a national data bank to keep records of who has received an implant. However, efforts to create such a data bank have been blocked by concerns about patient privacy. David Feigal, director of the FDA's Center for Devices and Radiological Health, said, "The interest in protecting patient privacy is pretty strong. It isn't even something potentially embarrassing like penile or breast implants. Even people with heart valves or rods in their spines worry about being disadvantaged with insurance or employment (if their records were somehow made public)" (Appleby, USA Today, 10/22).