DRUG SAFETY: A Call For New FDA Monitoring Office
An article in this week's Journal of the American Medical Association argues that the Food and Drug Administration should establish a new office to "evaluate the safety of thousands of drugs." The authors suggests funding the new FDA office with "an industry tax of a penny a prescription," which they say could raise $24 million annually. The article contends that the new office is needed because the FDA "focuses on approving new drugs but spends too little time and money on monitoring side effects after drugs" get marketing approval (Zerwick, Winston-Salem Journal, 5/20). One of the authors, George Washington University health policy analyst Thomas Moore, said: "The FDA doesn't have the money, the manpower or the mandate to do a proper job of monitoring the risks of drugs once they're approved. ... We need an independent Office of Drug Safety to monitor the risks of drugs; to report to the public on the safety of drugs; to recommend actions that would reduce the toll of deaths and injuries" ("World News Tonight," ABC, 5/19).
According to the article, as many as "100,000 people die each year from injuries linked to prescription drugs." The authors recommend that to reduce this number, the FDA should "do a better job of estimating the number of deaths and injuries associated with prescription drugs, and they need a more systematic way of collecting information about adverse side effects." The author also suggest that the FDA improve its system for communicating important news about adverse reactions to physicians and that "regulators need to be more aggressive about monitoring drugs instead of relying on voluntary reports from doctors." Co-author Dr. Curt Furberg, the chair of the public health department at Wake Forest University Medical School, said: "In my view we can probably cut the number of deaths related to drugs by 50%. You have to understand the research, and I think you need some compassion also. I think they're both lacking" (Winston-Salem Journal, 5/20).
Independence Is Key
The JAMA article argues that the FDA office overseeing drugs on the market needs to have "the authority, independence, funds and legal mandate to undertake ... the major tasks that define a basic drug safety monitoring program." The authors note that in Britain, an independent safety office can "order changes in product labeling and even may order outright drug withdrawal." In France, they note, drug safety is monitored by "a well-developed network of 30 regional pharmacovigilance centers, a national database that practitioners can query, and an important drug safety journal." Backing their call for an industry tax to fund the new FDA office, the authors write: "The drug industry should be no less liable for the costs of its safety regulation than the nuclear industry, which pays for the full costs of the Nuclear Regulatory Commission" (JAMA, 5/20 issue).
No So Fast
A statement issued by the head of Pharmaceutical Research and Manufacturers of America said drugmakers are "strongly committed to reducing the number of adverse drug reactions." However, the statement pans the JAMA article's recommendation for a new tax: "another new health-care tax or user fee is not the solution" (Winston-Salem Journal, 5/20).
ABC's John McKenzie looked at one FDA program called MedWatch which encourages health professionals to fill out a form each time a medication might be involved in a patient's death or injury. McKenzie reported, "ABC News has learned there is a backlog of at least 100,000 of these reports which the FDA has yet to process." Part of the problem, McKenzie reported, "is a new computer system at the FDA that's riddled with glitches. Another problem is manpower. For the past decade the FDA has been under increasing pressure to approve new drugs more quickly, so the FDA now has about 1,500 people focusing primarily on approving new drugs and only 52 full-time employees monitoring drugs already on the market. That's 52 people to follow almost 20,000 prescription drugs." Public Citizen's Dr. Sidney Wolfe said, "The public does not fully, or even remotely appreciate the dangers that they're being subjected to more and more every year because of the inadequate performance of the FDA." McKenzie noted that the FDA, in a written response to ABC News, "said 'The FDA is working to improve its reporting systems and scientific infrastructure' and said, 'The most serious adverse events are promptly evaluated and acted upon'" ("World News Tonight," 5/19).
Sen. Jim Jeffords (R-VT), asked by ABC's Peter Jennings about his views on reforming the FDA's drug monitoring functions: "Anytime you get a report that shows that thousands of people are dying as a result of this situation you immediately have to make it a priority and start ensuring that what we do have in place, will it be appropriate and if not we should demand other appropriate action." Asked if he is "utterly convinced" that the monitoring situation at the FDA "has got to be changed and got to be changed immediately," Jeffords said: "There's no question in my mind that we have to examine it and I would say yes, it obviously needs changes if this report is accurate and I have no reason to believe that it's not" ("World News Tonight," 5/19).
Kudos From The L.A. Times
An editorial in today's Los Angeles Times says the JAMA article outlines "a reasonable, effective solution" to the problem of adverse drug reactions. The editorial further states: "Congress and the Clinton administration should not let the FDA be cowed into forgetting oversight of drugs once they have landed on shelves" (5/21).