Lawful Search and Criminal Charges for Not Registering as a Manufacturer?

Pharmacy Times, February 2017 Infectious Disease, Volume 83, Issue 2

When an individual in the United States imports raw materials to make and distribute items classified as prescription medications, may the government pursue criminal charges against the individual for violation of the Federal Food, Drug, and Cosmetic Act?

ISSUE OF THE CASE

When an individual in the United States imports raw materials to make and distribute items classified as prescription medications, may the government pursue criminal charges against the individual for violation of the Federal Food, Drug, and Cosmetic Act (FDCA) based on evidence secured during a search to which his girlfriend gave consent?

FACTS OF THE CASE

An individual in a Midwestern state imported active ingredients for products containing sildenafil, vardenafil, tadalafil, finasteride, albuterol for use as an antiestrogen medication, and clenbuterol, which is FDA approved only for use in equine patients, not in humans. He marketed and distributed the products from his home using the Internet.

He was indicted and charged with 23 separate counts alleging fraudulent manufacture and sale of pharmaceuticals without being registered with the FDA. The investigation was launched when US Customs and Border Protection agents intercepted 2 packages believed to contain human growth hormone (HGH) that were addressed to the defendant’s residence. HGH is subject to FDA regulation, and the packages had been mailed from China, a major supplier of generic HGH.

Based on the intercepted contraband and on other information developed during an investigation, an agent from the FDA Office of Criminal Investigations obtained a search warrant for the individual’s home. His girlfriend’s apartment in another community was also searched because it was suspected of having a computer with evidence. No search warrant was obtained for this; the girlfriend allegedly gave consent for the search.

Before the criminal trial began, the defendant moved to suppress the evidence obtained in the search of the girlfriend’s apartment, where he was staying at the time. He argued that her consent to the search was involuntary due to coercion by government representatives. A hearing was held regarding the motion to bar the evidence from use during the trial.

THE COURT'S RULING

The evidence collected pursuant to the girlfriend’s consent to a search was permitted to be used at trial. The motion to suppress the evidence was granted.

THE COURT'S REASONING

The court reviewed the circumstances surrounding the consent for the search. The girlfriend and the defendant had been handcuffed when the law enforcement officials entered the residence. She maintained that his activities were perfectly legal and that he did read and sign the consent-to-search form without hesitation. She also expressed a desire to take a phone call she was expecting for an admission interview for a nursing degree program, for which she had recently completed the prerequisites. The authorities granted permission, but an FDA agent testified that there was no quid pro quo for the permission to take the phone call: it was not tied to consent to search the apartment. The FDA investigator testified that if the girlfriend had not given consent, he would have gone to federal court to obtain a search warrant.

The court emphasized that “The question whether a consent to a search was in fact voluntary or was the product of duress or coercion, express or implied, is a question of fact to be determined from the totality of all the circumstances.” The court concluded that she was a credible witness and that the program to which she was trying to gain admission, an accelerated baccalaureate degree program in nursing, was highly competitive. She may well have felt that her consent to the search was a precondition to participating in the admission interview telephone call. The government had the burden of proving that the consent for the search was truly voluntary, but it had not done so, in the view of the judge hearing the motion.

The case proceeded to trial without the additional evidence that would have been obtained from the apartment. FDA witnesses testified about the dangers of the pharmaceuticals being freely available without prescription. The defendant claimed they were being distributed for research purposes, but they were sold on health and fitness websites and were available in various colors and flavors. At the conclusion of the trial, he was convicted of 23 felony violations of the FDCA for operating an unregistered manufacturing facility and acting with intent to defraud the FDA.

Dr. Fink is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.