FDA Officials Outline Rules for Oversight Board, Drug Safety Initiatives
Members of FDA's new Drug Safety Oversight Board will be subject to strict conflict-of-interest requirements under rules outlined on Friday by Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, the Philadelphia Inquirer reports. At present, members of many FDA advisory committees are sometimes allowed to issue recommendations on a drug even if they have worked on its development or had accepted money from the manufacturer. Galson said, "It's been very controversial that we often waive these conflict-of-interest (rules) for advisory committees. We will not be doing that for this board."
Galson and other FDA officials, speaking via "live Internet hookup" with drug industry representatives and journalists, also on Friday addressed FDA's new drug safety initiatives, the Inquirer reports. Under the new rules, drug companies will not be allowed to edit or challenge safety information in advance of its posting on the FDA's Drug Watch Web site, according to FDA Office of New Drugs Director John Jenkins. In addition, authority over which warnings will be posted on the Web site will be given to members of the drug safety oversight board, some of whom were announced Wednesday. Jenkins said that if such a system had been in place earlier, it might have affected the events surrounding the withdrawal of Merck's COX-2 inhibitor Vioxx and the warning of a possible increased risk of suicide in adolescents taking antidepressants.
Jenkins said, "I think it's likely that (Vioxx) would have been on" the Drug Watch site, "although I don't know how the oversight board might have altered events as they played out." The Drug Watch Web site currently lists risks for more than 200 prescription drugs (Ginsberg, Philadelphia Inquirer, 5/21). The safety information posted on the Web site also emphasizes risks posed by off-label use of drugs.
Galson called listing off-label risks "a very important aspect" of the site. He added, "As you know, we don't regulate the practice of medicine. We have no way of preventing physicians from using drugs off label.'' However, Galson said the agency has an obligation to inform consumers of off-label risks (Young, Knight Ridder/San Jose Mercury News, 5/21).
Drug Watch is "about more information, better information, faster information. It's not about getting people to take fewer drugs," Galson said (Philadelphia Inquirer, 5/21). The American Medical Association and the Pharmaceutical Research and Manufacturers of America did not comment on the new rules but said they are evaluating the Web site and will submit formal comments to FDA. Larry Sasich of Public Citizen's Health Research Group said, "I don't think they had the political courage even a few years ago to take these kinds of steps" (Knight Ridder/San Jose Mercury News, 5/21).