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After a controversial year of drug recalls, the FDA was under attack for failing to adequately protect consumers from dangerous drugs. Currently, the FDA has the Adverse Event Reporting System, or AERS, to collect voluntary reports of possible reactions from physicians, pharmacists and patients, but the reporting systems has many inadequacies. (Filing of such reports is mandatory for drug companies.)
Experts have estimated just 10 percent of potential drug side effects are reported, and Public Citizen’s Sidney Wolfe believes though the reports can be helpful, they are too scarce to indicate dangerous trends. The federal agency has also been criticized for sitting on potential drug safety problems for two to three years before acting, allowing an even larger pool of patients to be exposed to sometimes deadly effects.
The FDA will begin a two-day meeting on May 18th with a panel of outside advisers to evaluate and discuss possible improvements for the system. Even the agency admits AERS has flaws. Head of the FDA’s statistical science office, Paul Seligman, referred to the reports flaws in a recent letter to the panelists before the meeting as “often missing important clinical information” and that they “are not systematically collected.”
In 2004, the FDA said it received about 400,000 reports and an estimated three-fourths were related to drugs. The majority of drug reports, 40 percent, were submitted online, with the remaining 60 percent split between mail-ins and faxed paper forms. Some doctors have complained that with time pressures it is difficult to download forms or use the Web site.
FDA officials are currently working on an updated, easier-to-use Web based reporting system that would directly send many reports to the FDA’s database.