FDA Enforcement Activities Protect Public : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Neither firm had performed any studies to demonstrate the drug's safety, nor did either apply for a new drug approval for E-Ferol. FDA inspected both Carter Glogau Laboratories and OJF, both of which refused to provide information on the development of the drug. The agency, however, was able to secure evidence, in part from a civil litigation involving E-Ferol, and it brought the case before a grand jury.

In July 1987 both firms, their presidents, and one vice president were indicted on 25 felony counts, including conspiracy, mail and wire frauds, and misbranding and unapproved drug charges. The presidents of the firms were each sentenced to $130,000 fines and nine years in jail (all but six months of each sentence was dismissed), and one vice president was fined $12,000 and sentenced to eight years in jail (all but six months was dismissed). The two firms were sentenced to pay a total of $260,000 in fines and $215,000 for the cost of the government investigation.

Mexican Steroid Smuggling Ring

In the fall of 1986, FDA's national steroid coordinator learned about the existence of manufactured counterfeit prescription steroid drugs on the black market. Following leads supplied by the Phoenix police department, FDA investigators found evidence that the drugs were manufactured in Mexico and smuggled into the United States.

At FDA's request, U.S. Customs provided dozens of agents to assist in an investigation that in 1987 resulted in the indictment of the owner of a multimillion-dollar pharmaceutical firm in Mexico and of a ring of smugglers who brought into the United States millions of dollars worth of counterfeit prescription steroids. Although the Mexican citizens who were involved could not be apprehended, all 30 individuals charged in the case pleaded guilty and were sentenced to up to seven years in jail.

Heptachlor-Treated Seed

FDA inspection of a gasohol plant operated by J.E.W. (Jack E. White), Inc., established that the firm produced feed from high-moisture grain and seeds treated with heptachlor, a pesticide toxic to humans, which left violative residues in the milk of cows that consumed it. FDA analysis showed heptachlor levels 1,000 times the allowable limit in feeds and more than 120 times the amount permitted in milk.

As a result, 11 firms recalled their milk and dairy pro-ducts, and, under FDA's coordination, the Federal Bureau of Investigation, U.S. Department of Agriculture, Environmental Protection Agency, and the Arkansas State Health Department launched an investigation into the violations.

Based on the collected evidence, a federal grand jury indicted four individuals, including Jack E. White, on 52 counts, including racketeering, mail fraud, and FDA felony counts of contamination of feed. White and two other defendants were convicted and sentenced to prison terms of from one to three years and fined up to $7,500 each. The fourth defendant was fined $5,000 and placed on three years' probation.

Bulk Veterinary Drugs

In January 1987 FDA forwarded to the Department of Justice a recommendation for a criminal investigation involving bulk veterinary drugs. The possibility of violations had been under investigation for nearly three years by six FDA district offices.

The evidence collected by FDA and the grand juries revealed smuggling, conspiracy, adulteration, and misbranding of animal drugs in 15 states and foreign countries, including West Germany, the Netherlands, Canada, and the Grand Cayman Islands. More than 32 tons of adulterated, misbranded or smuggled drugs worth $800,000 were seized in Illinois and Nebraska and by U.S. Customs.

So far, 41 individuals in six firms have been convicted in connection with the case and sentenced to fines, imprisonment or both. Jeffrey A. Engel, president of Custom Feed Blenders, was sentenced to three years in jail (all but six months suspended), a $10,000 fine, and 1,500 hours of community service. Two importers, Heinz G. Dall and Robert M. Clack, were sentenced to two years in prison and a $40,000 fine each. (For more information on this case, see the Investigators' Reports section in this issue.)

Clinical Studies

Following an FDA inspection of clinical investigations by Robert Fogari, M.D., of Jersey City, N.J., of a drug for arthritis, a grand jury subpoenaed more than 50,000 documents bearing on his previous studies. It was suspected that the studies were not in compliance with applicable laws and FDA regulations.

An FDA compliance officer interviewed more than 200 patients, study assistants, and representatives of the nine drug companies that had paid Fogari close to $2 million for his clinical work. As a result, Fogari was charged with conspiracy and 15 counts of submitting false documents in support of applications for approval to study a new drug in humans and to market new drugs. The data supplied by Fogari were excluded from approval applications submitted to FDA.

Fogari was tried and halfway through the trial changed his plea to guilty. He was sentenced in February 1989 to three years in prison, a $2 million fine, and $1.8 million in restitution to compensate the drug firms he had defrauded. He also received two lesser jail sentences to run consecutively and probation for five years. A month later, the New Jersey Board of Medical Examiners revoked Dr. Fogari's medical license.

Falsified Tests

The case resulted from a major FDA investigation of Industrial Bio-Test (IBT), which revealed systematic false reporting of drug toxicity in animals and animal health status. The company had its employees replace dead or dying animals to falsify results of studies conducted for drug and cosmetic companies. The toxicity reports were later filed by product sponsors in support of their applications for FDA product approval.

After a six-month trial in Chicago, three IBT officials were convicted of mail fraud, wire fraud, and of making false statements about animal studies involving a deodorant ingredient and an anti-inflammatory drug. One defendant was sentenced to a year in prison and four years' probation. Two were sentenced to six months in jail each and two years' probation.

These examples — as well others that have appeared in the Notices of Judgment (now Summaries of Court Actions) and Investigators' Reports sections of this magazine — show that FDA takes seriously its mandate of a scientifically based law enforcement agency. Despite scarce resources, the agency has not spared effort to meet its twin responsibility of safeguarding public health and ensuring honesty and fair-dealing between the regulated industry and consumers.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.