WSJ: FDA’s Drug-Safety Computer-Tracking System Flawed

The U.S. Food and Drug Administration’s (FDA) is facing serious technological issues related to its drug-safety computer-tracking system, according to a story in the Wall Street Journal. The Journal’s claim is based on a classified report commissioned by the FDA and produced by a consulting firm called the Breckenridge Institute.

According to the Journal’s interpretation of the report, the FDA has “bungled its effort to build a new system for detecting the side effects of medicines after they go on the market” and “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.” The paper quoted the report as saying that the flawed system is “frustrating and undermining the post-marketing drug safety work.”

The report implies that much of the problem stems from the FDA’s desire to build its own software technology, as opposed to using “off-the-shelf” software. The agency intends to implement a new software system, but the development of that system is years behind schedule, meaning that a new system will probably not be in place for at least two years possibly more.

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