FDA Enforcement Actions Fall, Yet Violation Reports Haven’t

Food and Drug Administration enforcement actions targeting safety problems, quality lapses and misleading claims have fallen sharply even though violations have not, according to statistics released Monday by Rep. Henry A. Waxman (D-Los Angeles).

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

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

“FDA can’t do its job when its enforcement arm is tied behind its back,” Waxman said.

But an FDA spokesman said the statistics did not take into account the agency’s strategy of focusing scarce enforcement resources on big cases.

Last year, according to the agency, it ordered the seizure of Paxil antidepressants and Avandamet diabetes medication by GlaxoSmithKline; intravenous infusion pumps by Baxter Healthcare Corp.; and hospital beds by Vail Products Inc. because of manufacturing or performance problems. And in 2002, it obtained a $500-million penalty against Schering-Plough Corp. 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 (R-Wyo.) and Edward M. Kennedy (D-Mass.) would require the agency and drug manufacturers to develop a safety plan for every new drug and to follow FDA approval with studies and monitoring.

The report found fewer warning letters issued by each of the FDA’s five centers, which together are responsible for a range of products, including drugs, medical devices and foods. Warning letters are an intermediate enforcement measure, less dire than criminal prosecution, civil fines or product seizures. The letters require written response from the company; failure to correct violations can have serious consequences.

“I think there is a public health problem here,” said Dr. Michael Wilkes, vice dean for medical education at the UC Davis medical school.

Wilkes reviewed several dozen cases collected by Waxman’s investigators in which inspectors had recommended action but headquarters disagreed or did not act promptly.

The report identified 138 cases in which headquarters did not take enforcement actions recommended by inspectors. Many involved medium-sized 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 ingredient that could prompt dangerous side effects, particularly in children. Another involved a hangover remedy that contained toxic levels of caffeine and had sent three people to the emergency room. In both cases, FDA headquarters did not send warning letters within specified timeframes.

In another case, the agency ultimately did not take 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.