The FDA and incompetence or even corruption? Who woulda thunk-it? One would almost suspect the incompetence was intentional so as to prop up the profits of the FDA's master: the pharmaceutical industry. Doing a heckuva job there, Douglas Throckmorton (deputy director of the agency's drug center).
Report Blasts FDA's System to Track Drugs The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself.As a result, the agency must continue to rely on its existing “dysfunctional” computer system as a primary tool for tracking the safety of medications sold in the U.S., according to the November 2006 report, which hasn't been made public.
The situation is “frustrating and undermining...the post-marketing drug safety work” of its staff “because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements,” says the report. It was prepared by the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo.
The FDA's drug-tracking system, called the Adverse Event Reporting System, consists of a database and other software and hardware that amass and help sift reports of potential side effects that have been filed by drug makers, doctors and others. The data are the FDA's main way to detect drug-related hazards, and can lead to changes in label warnings or even withdrawals of drugs from the market.
But, the report says, FDA safety experts waste time -- an average of 45 minutes per day -- dealing with the inefficiencies and snags caused by the current software. The Adverse Event Reporting System is overwhelmed by the growing volume of adverse-event reports, which exceeds 400,000 a year, the report says.
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Echoing other recent outside examinations of the FDA, the Breckenridge analysts say the “root cause” of the problems can be found in the culture of the agency's drug regulators. More specifically, the report largely blames a “lack of effective leadership and management” by the center's Office of Information Technology, which it says mishandled the initiative through bureaucratic infighting, flawed planning and duplicative work performed by outside contractors.
Mark Bodnarczuk, executive director of the Breckenridge Institute, said he stands by the contents of the document. After it was completed, the FDA asked him to delete much of it, he said: “What they asked me to do was gut the report, and I refused to do it.” The FDA's Dr. Throckmorton said he believes Breckenridge was asked by FDA to extend its work, at no cost, which would have “given us an opportunity to talk about those misunderstandings, those inaccuracies.
FDA contracting practices, as well as the agency's handling of drug safety, are already the focus of congressional investigations. Senate Finance Committee Chairman Max Baucus, a Montana Democrat, and ranking Republican Charles Grassley of Iowa have sent a letter to the FDA about the computer-system issue. Mr. Baucus said the report raises ”troubling questions,“ and Mr. Grassley said the report is evidence of a ”broken-down process“ at the agency. In the House Energy and Commerce Committee, Democrats John Dingell and Bart Stupak, both of Michigan, are also examining FDA contracting.
Tags: FDA, /incompetence, /Pharmaceuticals
