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FDA Official Says Agency Had Increased Inspections of McNeil Plant.

Today’s Medical News From Newspapers, TV, Radio and the Journals Friday, May 7, 2010

Quality and Safety

USA Today (5/7, Young) reports, “The drug manufacturing plant responsible for an international recall of children’s Tylenol and other medicines has been on a stepped-up inspection schedule by federal regulators since 2008.” In fact, the “McNeil Consumer Healthcare plant in Fort Washington, Pa., has been inspected annually since 2008, says Douglas Stearn, an assistant director for compliance at” the FDA. Typically, “because of limited resources, the FDA inspects domestic drug plants only about once every two to three years, Stearn said. The agency uses a risk-based system to set inspection schedules,” and “plants making drugs with greater safety risks, such as blood thinners, are inspected more frequently, as are plants that have a more troubled inspection history.”

Lawmakers ask Hamburg about FDA’s involvement with McNeil. CQ HealthBeat (5/7, Norman) reports, “The chairman and top Republican on the House Oversight and Government Reform Committee wrote Food and Drug Commissioner Margaret Hamburg on Thursday to raise questions about the agency’s actions in connection with a recall of children’s Tylenol medication.” CQ adds, “Chairman Edolphus Towns (D-NY) and Rep. Darrell Issa (R-CA) asked Hamburg about the FDA’s dealings with McNeil Consumer HealthCare, a division of Johnson & Johnson. An FDA inspection of a McNeil plant in Fort Washington, Pa., found numerous problems, including bacteria in raw materials, leading the company to suspend production on Tuesday of children’s over-the-counter medications, which also included Motrin, Zyrtec and Benadryl.” Reuters (5/7) points out that there have been four recalls of J&J OTC drugs over the past year.

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