Drop in FDA warning letters points to shift in enforcement.

FDA warning letters to industry dropped by half in the last 10 years, according to a June 6 report in "The Wall Street Journal."

In 2002, FDA changed its policies and required that all warning letters go through FDA's chief counsel office, a move designed to strengthen the letters and make them legally consistent and credible.

In fiscal year 2001, the year before this change took effect, the agency issued 1,032 warning letters. In 2006, FDA sent 538 letters, and in 2007 it sent 471, FDA data show.

Some members of Congress, FDA staffers and former FDA officials have criticized the change, suggesting it favored industry. Since taking control of Congress in 2007, Democrats have stepped up attacks on what they charge is the Bush administration's tendency to tolerate lax regulatory enforcement at FDA and a number of other government agencies.

"The number of warning letters has always been one of the surrogate measures of FDA's enforcement performance," said David Kessler, M.D., who was FDA commissioner from 1990 to 1997 under President Bill Clinton. "It's not the only measure, but any significant drop raises significant questions of what's going on."

Dan Troy, former FDA general counsel and an architect of the policy change, said the legal review process was aimed at making the letters consistent and legally credible and countering industry sentiment that FDA didn't always follow through on the warnings.

The current FDA commissioner, Andrew von Eschenbach, acknowledged the drop in warning letters, but said the agency sends them now for more serious deviations rather than minor ones, the Journal reported.

David Elder, director of FDA's office of enforcement, warned against measuring the agency's enforcement success by counting warning letters.

The decline in warning letters came as FDA changed warning letters to separate companies for similar violations, FDA alerts the industry via press releases and other forms of communication when it notices a trend of problems, he said.

This method, Elder said, results in "more widespread" compliance than an individual warning letter

FDA also has ordered more product recalls, agency data show. From 1996 to 2000, the agency recalled an average of 3,500 products annually. From 2001 to 2006, that average rose to 4,700 a year.

Other measures of FDA enforcement paint a mixed picture of enforcement success.

Foreign and domestic plant inspections by FDA have fallen in the last five years, data from the agency's Web site show. In 2003, FDA conducted 22,543 inspections. In 2004, that figure was 21,805, in 2005 it was 19,803 and in 2006, the agency inspected 17,641 plants.

The agency has come under heavy criticism from House lawmakers for its infrequent inspection of plants abroad in the wake of contamination problems with heparin, a widely used blood thinner that has been linked to hundreds of allergic reactions and 81 deaths.

The agency has acknowledged it doesn't have enough resources to conduct foreign inspections and recently received $20 million to beef up its presence abroad.

A review of FDA enforcement by a government watchdog blamed the new chief counsel's office review process for slowing down another type of regulatory warning to industry.

A 2006 Government Accountability Office report, which examined regulatory letters, found the chief counsel's review lengthened the time it took for FDA to send out letters to companies about misleading direct-to-consumer television ads.

The GAO hasn't studied how the policy change has affected warning letters in general. Elder said he doesn't believe the chief counsel's review has much effect on the number of letters going out or the time frame for sending them.