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.
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 U.S. Food and Drug Administration.
On average, 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. 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.
"There had been issues raised in these past inspections," Stearn said. Some involved manufacturing, he said, but he couldn't say whether that was the reason for the increased frequency.
The FDA and McNeil have declined to release reports of inspections before the one in April that triggered last week's wide-ranging recall.
FDA: Drug maker knew of contamination
A congressional oversight committee called on the FDA Thursday to produce those records and others by May 17 as part of its investigation into what they called "alarming" problems the FDA found in April, especially the use of a bacteria-contaminated ingredient to make medicine. USA TODAY has asked for the release of recent inspections reports since Sunday.
The recall of infant's and children's liquid Tylenol, Motrin, Zyrtec and Benadryl products is the third recall in recent months involving McNeil plants, note Reps. Edolphus Towns, D-N.Y., and Darrell Issa, R-Calif., in their letter requesting documents from the FDA. Towns chairs the House Committee on Oversight and Government Reform; Issa is its top Republican member.
This raises "questions as to the adequacy of FDA's response to repeated problems with McNeil's manufacturing practices," the lawmakers wrote.
McNeil spokesman Marc Boston said the company is addressing the "unacceptable" quality issues the FDA has flagged.
The chance of serious harm is "remote" from drugs in the recall, according to the FDA. In late January, the FDA was at the plant investigating a complaint, but Stearn could not provide details. Before last month, the plant had full inspections in October 2006, February 2008 and May 2009, he said.
Stearn said it's the drugmakers' responsibility to maintain the strength, quality and purity of their medicines. "We try to ensure that that obligation is met," he said.
If it isn't, said Sidney Wolfe at the watchdog group Public Citizen, the FDA must take action: "If (the plants) fail in that responsibility, something drastic should happen."Wild horser
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