The Food and Drug Administration has failed to protect the nation's meat, milk and egg supply from contamination with potentially hazardous drug residues, including an antibacterial chemical that could cause an incurable type of anemia in one of every 40,000 Americans exposed to it, a House committee charged yesterday.
The House Government Operations Committee, in a unanimous report on the first investigation of animal-drug law in more than a decade, said the FDA has "lost sight of its mission" by putting the interests of veterinarians and the livestock industry ahead of its responsibility to protect public health.
According to the report, 90 percent of the 20,000 or more newanimal drugs on the market have not been approved as safe and effective, and FDA officials routinely look the other way when drugs are used on animals for which they are not intended.
The result is that neither the FDA nor any other federal agency knows what residues may be in the nation's food supply or whether those residues pose a health hazard, the report said.
"The committee believes that nothing short of a major agency commitment is likely to bring this massive problem under some semblance of control," said the report, which stemmed from a six-month investigation by the panel's intergovernmental relations and human resources subcommittee.
The inquiry found the FDA "has consistently disregarded its reponsibility," said subcommittee Chairman Ted Weiss (D-N.Y.). "The law requires, and consumers deserve, far more public health protection than the agency has provided."
A copy of the report was delivered to the FDA a week in advance of its release yesterday. An FDA spokesman said the agency had no formal response.
Among the examples the committee cited was chloramphenicol, a potent antibacterial drug approved for use only on dogs and cats. Its use on food-producing animals, such as beef and dairy cattle, poultry and hogs, is forbidden because the drug is capable of causing aplastic anemia in susceptible humans.
FDA inspectors confirmed that the drug is being widely used on cattle and hogs despite the restrictions, but the agency took no action against the chemical until July, shortly before Weiss convened the first of two hearings on animal-drug practices.
Lester Crawford, then director of FDA's Center for Veterinary Medicine, testified at that hearing that chloramphenicol, in any amount, is capable of inducing aplastic anemia in those susceptible to the drug, or one in 40,000 persons. The disease, he said, is "irreversible, untreatable and inexorably fatal."
An FDA spokesman said last week the agency has decided to ban an oral form of chloramphenicol, thought to be the most widely misused, but will leave the drug on the market in tablet and capsule form.
The committee said it was concerned that the drug still will be subject to misuse, noting that agency scientists have protested the FDA's approval of 2-gram and 2.5-gram tablets, which are considered too large to use on even large dogs.
Among the report's findings:
*The FDA has failed to remove several potentially carcinogenic animal drugs from the market. Among them are nitrofurans, chemicals proposed for withdrawal more than 14 years ago but just scheduled for a formal hearing last year.
*The FDA "fostered the illegal marketing" of methylene blue to treat nitrate poisoning in cattle, despite evidence that the chemical is a mutagen and potential carcinogen. According to FDA documents, Crawford notified the manufacturer that it could make the unapproved compound available to veterinarians. Later, the FDA sent a bulletin to veterinarians telling them where they could get the chemical.
*In an effort to speed the approval of new drugs, the FDA dissolved its human food safety program and merged its staff with the drug approval office. The actions were taken despite two internal reports warning that the moves would subordinate safety concerns to the agency's drive to get new drugs on the market.
*The FDA is unable to control the widespread, illegal sale of veterinary prescription drugs. The committee cited an FDA investigator who, in a two-week trip across Iowa, was able to buy prescription drugs illegally over the counter in 40 out of 43 tries.
*The agency knowingly circumvented the law by granting emergency approval for the use of a parasite-killing drug for cattle and sheep. Tests later confirmed the agency's suspicions that the drug caused cancer, but the "temporary" designation kept it on the market for almost five years, until another parasite-killing drug could be approved to replace it.