Report shows steep decline in FDA enforcement actions

Number of violations about the same

agency says it focuses on big cases

June 27, 2006|By RICARDO ALONSO-ZALDIVAR | RICARDO ALONSO-ZALDIVAR,LOS ANGELES TIMES

WASHINGTON -- Food and Drug Administration enforcement actions targeting safety problems, quality lapses and misleading claims have fallen off sharply even though violations have not, according to statistics released yesterday by Rep. Henry A. Waxman, a California Democrat.

In 2005, FDA headquarters issued 535 "warning letters" to companies, a 54 percent decline from 1,154 such notices issued in 2000, according to a report by the House Government Reform Committee's Democratic staff.

However, over the same period, the number of violations reported by FDA inspectors in the field barely budged, dipping just 1 percent - from 6,334 in 2000 to 6,268 in 2005.

"FDA can't do its job when its enforcement arm is tied behind its back," Waxman said.

But an FDA spokesman said the statistics do not consider the agency's strategy of focusing scarce enforcement resources on big cases.

Last year, according to the agency, it ordered the seizure of Glaxo- SmithKline's Paxil antidepressants and Avandamet diabetes medication, Baxter Healthcare Corp.'s intravenous infusion pumps, and Vail Products' hospital beds because of manufacturing or performance problems. And in 2002, it obtained a $500 million penalty against Schering-Plough for manufacturing problems involving a number of drugs, including Claritin, an allergy medication.

"FDA enforcement cannot be properly judged by counting the number of actions taken by the agency," said David Elder, the agency's head of enforcement. "FDA has increasingly used an enforcement strategy, based on efficient risk-management principles, that focuses on combating the greatest public health risks and maximizing our deterrent effect against potential violators."

Waxman's report comes as influential lawmakers in the Senate are drafting legislation to strengthen the FDA's drug safety program. The proposal by Sens. Michael B. Enzi, a Wyoming Republican, and Edward M. Kennedy, a Massachusetts Democrat, would require the agency and drug manufacturers to develop an individual safety plan for every new drug and to follow through with studies and monitoring after approval.

The report found a decline in the number of warning letters issued by each of the FDA's five centers, which together are responsible for a broad range of products, including drugs, medical devices and foods.

Warning letters are an intermediate type of enforcement measure, less dire than criminal prosecution, civil fines or product seizures. The letters require a written response from the company, and failure to correct the violation can have severe consequences.

"I think there is a public health problem here," said Dr. Michael Wilkes, vice dean for medical education at the University of California, Davis, medical school.

Wilkes reviewed several dozen cases collected by Waxman's investigators in which inspectors had recommended action but headquarters disagreed or failed to act in a timely manner. The report identified 138 cases in which headquarters failed to take enforcement actions recommended by inspectors.

Many involved medium-size or small companies selling over-the-counter remedies, not pharmaceutical giants. "I can't explain why the FDA is taking a position where they are being passive," Wilkes said.

One of the cases Wilkes reviewed involved an over-the-counter asthma medication containing an active ingredient that could prompt dangerous side effects, particularly in children. Another involved a hangover remedy containing toxic levels of caffeine that sent three people to the emergency room. In both cases, FDA headquarters failed to act within specified time frames for sending warning letters.

In another case, the agency ultimately failed to take any enforcement action against an Ohio medical gas supplier after a nitrogen tank mislabeled as oxygen was connected to a nursing home's oxygen delivery system. Four patients died as a result.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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