FDA to Review Safety Notification ProceduresFeb 29, 2008 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) is looking at how it tells the public about safety concerns with foods, prescription drugs, medical devices, and other products it regulates, the agency's commissioner said on Thursday. "How we communicate what we do is as important as what it is we are doing," Dr. Andrew von Eschenbach told the first meeting of a new advisory panel on risk communication. "Quite candidly, if one looks at external data there has been an erosion of trust. Some of that is not necessarily because people believe we are doing the wrong thing, but basically because perhaps they need to better understand and appreciate what we are doing," he added.
The FDA issues warnings about drug side effects, recalls of tainted food, and defective medical devices. Often the agency issues press releases to the media or releases statements on its Web site. In recent years, the agency has started making public announcements about potential risks of medicines before officials determine whether the problems are drug-related. Some experts worry that the warnings create confusion or balance is lacking when it comes to information about the product’s benefits. Von Eschenbach said the FDA would consider changing the way it explains product risks to the media and the public.
Meanwhile, the FDA has been criticized for not doing a thorough job protecting Americans from unsafe drugs. Representative Bart Stupak argued this point for years; his concerns became personal when, in 2000, his 17-year-old son, who was using the acne medication Accutane, committed suicide. If Americans "knew how little the FDA did to assure the food and drug supply, if the truth ever came out...people would be marching in the street," he says. "That's just one drug. There are many like that," Stupak said. Now, as the FDA is under fire for mistakes over international inspections and other issues, Stupak—an eight-term Democratic congressman and chairman of the Subcommittee on Oversight and Investigations of the House's powerful Energy and Commerce panel, which has jurisdiction over the FDA—is at the center of an aggressive effort by congressional Democrats to spotlight what they say are problems with the Bush administration's position on consumer-safety issues. Stupak's subcommittee is probing the FDA's ha
ndling of Baxter International Inc.’s heparin, the blood-thinning drug that has been potentially linked to hundreds of patient reactions and four deaths. The subcommittee is also examining Pfizer Inc.'s Lipitor, Vytorin from Schering-Plough Corporation and Merck & Company, and anemia drugs sold by Amgen Inc. and Johnson & Johnson. Ketek, an antibiotic from Sanofi-Aventis SA, has been under review for over a year. Stupak is holding hearings on the safety of imported food, medicines, and medical devices and says he has a bigger agenda adding, that "It's a broken agency."
Stupak called for the resignation of von Eschenbach and other top officials; von Eschenbach, who was confirmed to lead the FDA in late 2006, says they introduced a new food-safety plan, hired a chief information officer to manage information technology issues, and are working to install inspectors in countries including China and India.