HPM Attorneys Testify Before the U.S. Sentencing Commission on Proposed Sentencing Guidelines

We previously reported on the United States Sentencing Commission’s (“Commission”) proposed changes to its Sentencing Guidelines (“Guidelines”) that would likely greatly enhance the criminal penalties applied to some criminal violations of the FDC Act, including those added by the Prescription Drug Marketing Act of 1987 (“PDMA”).  On February 13, 2008, the Commission announced that a public briefing session will be held on February 13, 2008 from 9:30 AM to 11:30 AM to discuss the proposed Guideline changes.

Hyman, Phelps & McNamara, P.C. attorneys John R. Fleder and John A. Gilbert were selected to participate on the panel testifying before the Commission regarding the proposed Guideline changes concerning FDC Act and PDMA violations.  Both attorneys testified on February 13, 2008 with respect to § 2N2.1 of the proposed amended guidelines, which is titled “Violations of Statutes and Regulations Dealing With Any Food, Drug, Biological Product, Device, Cosmetic, or Agricultural Product.”  According to the Commission’s proposal issued in the Federal Register:

[T]he proposed amendment [to § 2N2.1] adds a specific offense characteristic at § 2N2.1 that applies if the defendant committed any part of the instant offense after sustaining a conviction of an offense under 21 U.S.C. § 331.  Because PDMA offenses at 21 U.S.C. §§ 353 and 381 are incorporated into the FDCA at 21 U.S.C. § 331 the proposed specific offense characteristic also is applicable to a second or subsequent violation of the PDMA. The proposed amendment also amends the commentary to § 2N2.1 to include substantial risk of bodily harm or death as a basis for an upward departure. In addition, there is an issue for comment regarding violations of the FDCA and PDMA.

Both Mr. Fleder and Mr. Gilbert take the position in their testimony (available here and here) that § 2N2.1 appears to be working as intended and that there is insufficient evidence for the case that the § 2N2.1 Guideline needs to be revised at this time.