Report blasts FDA’s drug tracking system

The FDA has “bungled” its efforts to build a new Adverse Event Reporting System (AERS) to detect the side effects of marketed medicines, The Wall Street Journal reports. An article in the Journal, citing an undisclosed report commissioned by the agency itself, stated that the FDA continues to rely on its existing “dysfunctional” computer system as a primary tool for tracking the safety of medications sold in the US. 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,” the report, prepared for the FDA by the consulting firm Breckinridge Institute, said. The report, completed in November 2006 but never released to the public, said that FDA experts spend an average of 45 minutes per day dealing with the inefficiencies and snags caused by the current software. The AERS is already overwhelmed by a growing volume of adverse event reports, which exceeds 400,000 a year, according to the Breckenridge report. The FDA has sought to upgrade the technology used in AERS for years, but efforts that date back to at least 2003 haven’t produced the planned successor, dubbed AERS II, the Breckenridge report stated. A new system isn’t likely to be up and running until 2009 and the FDA has already spent an estimated $25 million on its efforts. The Breckenridge report argued that the FDA instead could have had a new system working in 2005 if it had simply relied on off-the-shelf software. The FDA’s track record on drug safety has faced tough scrutiny in the wake of the 2004 withdrawal of Merck’s painkiller Vioxx, which was linked to cardiovascular problems. A document prepared by FDA officials in response to the report, which is marked as a draft, said the Breckenridge report is “riddled with editorial conclusions based on misleading or incorrect facts.” Deputy director of the FDA’s center for drugs Douglas Throckmorton said in the Journal report that the current AERS “is a system that is working” despite “exploding” amounts of data. “Is it the best it can be? Of course not,” he said. The FDA wants to develop a replacement “as quickly as anyone else does, but we want it to be done right.” Meanwhile, the FDA unveiled the final version of its "Drug Watch" system for reporting emerging safety information about prescription drugs for the public. The agency is designating those drugs for which new safety postings are available with a red asterisk next to the drug name, as listed on an index on the CDER section of the FDA Web site ( An asterisk signals the presence of a public health advisory, alert or information sheet for healthcare professional or patient. The format finalizes draft guidance issued last May, in which the agency proposed keeping a “Drug Watch” list. While introducing the new format to reporters last Friday, the FDA took some questions about placing the index page within the CDER Web site as opposed to making it reachable off FDA’s homepage. An official said the agency is evaluating ways to ease navigation. “There are clearly aspects of our Web site that are impenetrable,” said Paul Seligman, associate director for safety policy and communication.

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