The United States Sentencing Commission, which sets the guidelines that are usually followed by federal judges sentencing defendants convicted of federal crimes, has issued proposed Sentencing Guidelines that would greatly enhance the criminal penalties applied to some criminal violations of the Federal Food, Drug and Cosmetic Act.
Last year Pfizer paid a $35 million fine for its growth hormone Genotropin, based on the information I had provided to the justice department and the FBI in United States ex rel. Rost v. Pfizer, Inc., and a few months ago, Specialty Distribution Services, which is a unit of Express Scripts, and was the manager of Pfizer/Pharmacia's Genotropin Bridge Program, agreed to pay a $10.5 million fine for illegally supplying patients with HGH.
Clearly the Sentencing Commission doesn't feel this was enough.
The proposed amendments to the Guidelines do the following with respect to HGH:
Adds 21 U.S.C. § 333(e) - distribution of HGH - to the list of offenses to which § 2D1.1, the general controlled substance Guideline, applies.
Makes a defendant convicted of an HGH offense subject to a two level enhancement under § 2D1.1(b)(6) for “mass marketing [HGH] by means of an interactive computer service.” This existing specific offense characteristic currently applies to only controlled substances, which HGH is not.. Application Note 23 provides guidance regarding how this provision is applied as well as the definition of “interactive computer service.”
Adds 21 U.S.C. § 333(e)(2) - distribution of HGH to a person under 18 years of age - to the § 2D1.2 Guideline, which presently applies to controlled substance offenses involving protected locations (e.g., schools) or pregnant or underage persons.
The notice also identifies various issues for comment regarding HGH offenses.
The FDA Law blog has the complete news.
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