Hi-Tech Prosecution Offers FDA Model For Pursuing Bad Actors – Lawyer
This article was originally published in The Tan Sheet
Executive Summary
The successful prosecution of Hi-Tech Pharmaceuticals for counterfeiting generic Rx drugs should encourage FDA to pursue criminal charges against other companies selling adulterated products, according to food and drug attorney Marc Ullman
You may also be interested in...
FDA Actions Against Food Firms May Predict Aggressive Follow-Through
FDA's use of more serious tools against repeat offender food manufacturers suggests similar aggressive actions could await food and dietary supplement firms testing the agency's patience
Hi-Tech CEO sentenced for fake drugs
Jared R. Wheat is ordered to serve 50 months in federal prison and must forfeit $3 million gained through the production and marketing of counterfeit drugs - including Xanax, Vioxx and Viagra - with other executives from Hi-Tech Pharmaceuticals. Company founder and CEO Wheat, along with his co-conspirators, established a drug manufacturing facility in rural Belize that "complied with none of the sanitary, hygienic or quality-control regulations issued by the FDA," and subsequently sold unauthorized drugs online without a prescription, the Department of Justice says in a Feb. 3 release. Judge Jack T. Camp of the U.S. District Court for the Northern District of Georgia also places the Norcross, Ga.-based supplement firm on five years' probation. A separate case in which Hi-Tech was charged with making false and misleading claims about its supplement products did not play into the criminal prosecution (1"The Tan Sheet" Aug. 25, 2008, p. 7)
ERSP Refers NVE Pharmaceuticals’ AppuLoss Weight-Loss Ads To FTC
The Electronic Retailing Self-Regulation Program referred advertising for NVE Pharmaceuticals' AppuLoss dietary supplement to the Federal Trade Commission after the firm failed to respond to an inquiry