HPM Continues Coverage of the U.S. Sentencing Commission’s Proposed Sentencing Guideline Revisions

Over the past several weeks, FDA Law Blog has closely followed issues concerning the United States Sentencing Commission’s proposed changes to the Sentencing Guidelines that are applicable to certain FDA criminal offenses. In our most recent post, we reported on a February 13, 2008 public briefing session during which representative from FDA and Hyman, Phelps & McNamara, P.C. (“HPM”) testified before the Commission on the proposal. 

In the March 2008 issue of Thompson Publishing Group’s FDA Enforcement Manual, HPM’s Douglas B. Farquhar provides additional information and analysis on the proposal.  In the article, titled “Heightened Chance of Prison Time for Executives?,” Mr. Farquhar discusses how the Commission’s proposal “would dramatically increase the chances that an individual being sentenced for an FDA violation would be sentenced to prison time.” According to Mr. Farquhar, FDA’s suggestion at the February 13, 2008 public briefing session that all adulterated and misbranded drugs and medical devices are worthless “would dramatically increase prison sentences imposed on individuals convicted of felony violations of federal law on the manufacture of drugs and devices.”

We will continue to update you on this important and interesting issue as we learn additional information.