Thomas Bader, a licensed Colorado pharmacist, lost his human growth hormone (HGH) conviction appeal before the Tenth Circuit Court of Appeals this week, but succeeded in getting a $4.8 million forfeiture order overturned.
Bader owned and operated College Pharmacy, a compounding pharmacy located in Colorado Springs. (Though the Tenth Circuit never resolved what a "compounding" pharmacy is, PharmWatch.org described College Pharmacy as "one of several [pharmacies] that supply nonstandard products to offbeat physicians who do chelation therapy, mesotherapy, and other dubious treatments.")
Bader was convicted in February 2010 of importation and distribution of anabolic steroids and Chinese-manufactured HGH, reports ABC-7. The charges against Bader even alleged that some of Bader’s HGH went to minors.
In Spring 2004, Bader instructed Kevin Henry, a College Pharmacy sales representative, to locate an economical source of HGH for purchase and distribution. College Pharmacy subsequently began to order and import HGH in bulk quantities from the Genescience facility in China. Employees of College Pharmacy were then directed to repackage the imported HGH into smaller vials for distribution.
Under College Pharmacy’s repackaging protocol, employees copied the relevant HGH drug instruction guides from a Food and Drug Administration (FDA)-approved version of HGH known as Saizen, and included them with College Pharmacy’s own HGH drug, which they labeled and sold as Somatropin. If asked whether Somatropin was FDA-approved, College Pharmacy employees were instructed to explain that the FDA did not have jurisdiction in China, and to reassure customers that the imported HGH was manufactured in an FDA-approved Chinese facility. College Pharmacy also issued several promotional letters and advertisements which implied that Somatropin had been approved by the FDA.
The plan, as Bader’s conviction would suggest, ultimately back-fired.
On Thursday, the Tenth Circuit Court of Appeals affirmed Bader’s convictions for distribution of HGH, but reversed his convictions for possession and distribution of steroids and knowingly facilitating the sale of HGH illegally imported into the United States, and conspiring to do so. (The latter reversal was based on an instructional error.)
In light of the reversals, the Tenth Circuit remanded the forfeiture judgment to the district court for reconsideration.
- U.S. v. Thomas Bader (Tenth Circuit Court of Appeals)
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- Report: Limited FDA Survey of Compounded Drug Products (FDA)