Drop in FDA warning letters points to shift in enforcement.FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. warning letters to industry dropped by half in the last 10 years, according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. 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 David Kessler may refer to:
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 David Matthew Elder (September 23, 1975 in Atlanta, Georgia), is a professional baseball player who played pitcher in the Major Leagues from 2002-2003. He played for the Cleveland Indians. , 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 heparin (hĕp`ərĭn), anticoagulant produced by cells in many animals. A polysaccharide, heparin is found in the human body and occurs in greatest concentration in the tissues surrounding the capillaries of the lungs and the liver. , a widely used blood thinner blood thinner
A drug used to prevent the formation of blood clots.
blood thinner Vox populi Anticoagulant, see there that has been linked to hundreds of allergic reactions allergic reaction
A local or generalized reaction of an organism to internal or external contact with a specific allergen to which the organism has been previously sensitized. 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 The Government Accountability Office (GAO) is the audit, evaluation, and investigative arm of the United States Congress, and thus an agency in the Legislative Branch of the United States Government. report, which examined regulatory letters, found the chief counsel's review lengthened length·en
tr. & intr.v. length·ened, length·en·ing, length·ens
To make or become longer.
lengthen·er n. 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.