Sentencing Commission to Consider Amendments to Food and Drug Guidelines

December 4, 2007

For the first time in over a decade, the United States Sentencing Commission (the “Commission”) is considering amending the Sentencing Guidelines that are applied to individuals and organizations convicted of criminal violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 72 Fed. Reg. 51884 (Sept. 11, 2007). Interestingly, on July 31, 2007, when the Commission solicited public comments on its tentative proposed priorities for the upcoming amendment cycle (ending May 1, 2008) for the Guidelines, amendments to the Food and Drug Guideline were not among those priorities. See 72 Fed. Reg. 41795. Six weeks later, when the Commission published its notice of final priorities, “the treatment under the guidelines of . . . human growth hormone (HGH), Prescription Drug Marketing Act of 1987 (Pub. L. 100-293) offenses, and other food and drug violations . . .” was among those final priorities.

In the notice, the Commission has specifically identified two discrete aspects of the interplay between the FDCA and the Guidelines, but also broadly signaled that is examining whether the existing Guidelines for FDCA offenses are adequate to promote the goals of the Commission (just punishment, deterrence, incapacitation, and rehabilitation). It seems a safe bet that the Commission did not sua sponte decide that the Guidelines need to be watered down. Rather, it would appear the federal government, and, in particular, the U.S. Food and Drug Administration’s (“FDA”) Office of Criminal Investigations (“OCI”) are pushing for “stronger” guidelines for FDCA offenses. Apparently the FDA’s push for amendments is not new, but those efforts gained some traction this year, based–at least in part–on the increased visibility of HGH in the headlines.

With respect to HGH and the PDMA, it’s relatively clear why, if the Commission is going to look at the existing Food and Drug Guideline, 2N.2.1, those topics would be called out. For HGH, the Guidelines are clear–at present, there is no guideline for HGH. See Guidelines Manual § 2N2.1 Application Note 4 (“The Commission has not promulgated a guideline for violations of 21 U.S.C. § 333(e) (offenses involving human growth hormones).”). For PDMA offenses, the statutory maximum for those offenses in section 333(b) is 10 years, as compared to the 3 year statutory maximum for a felony under 333(a)(2), but 2N2.1 does not explicitly take account of the PDMA’s higher statutory maximum.

Recently, three attorneys from our firm met with five members of the Staff from the Commission to share our impressions of the FDCA Guidelines generally, and have gained valuable insights into the issues. It seems likely that the Commission will take some action with respect to the several FDCA Guidelines issues identified in the Federal Register notice. The window of opportunity to potentially affect the course that the Commission may take is closing quickly.

The Commission must submit Guideline amendments to Congress no later than May 1, 2008. An amendment requires a public Commission meeting, which would have to take place in April at the latest, and could come up for a vote in March. The Commission typically allows at least 60 calendar days for public comment on proposed amendments once those proposed amendments have been published. Therefore, a Commission vote on proposed amendments to the FDCA is likely in January 2008. Of course, we would expect that the Commission’s Staff will submit options to the Commission regarding these issues well in advance of that vote.

While participation in the public comment period, through comments or testimony at a likely public hearing, can influence Commission action on proposed amendments, there is an opportunity to influence the amendment process before the Commission votes to publish proposed amendments. Accordingly, interested persons hoping to influence the proposed amendments that the Commission will consider (likely in January) have very little time to provide the Commission with information that could affect the Commission’s decision.

By John R. Fleder, Douglas B. Farquhar and J.P. Ellison.

Categories: Enforcement