Sentencing Commission Recommends Two Changes to Sentencing Guidelines for FDC Act Offenses, but Generally Declines to Follow FDA Recommendations

May 4, 2008

As we previously reported (see post here and article here), FDA has been seeking stiffer sentences under the U.S. Sentencing Guidelines for at least the past five years.  For the preceding four years, the FDA’s pleas seemed to fall on deaf ears, but in this past year the Commission included FDC Act offenses in its priorities, held a public hearing, and received public comments with regard to some amendments the FDA asked the Commission to consider.  At the end of the process, FDA got some, but certainly not all or even most, of what it was seeking.

In the amendments to the Guidelines forwarded by the Commission to Congress on May 1, 2008, the Commission made two changes to the applicable Guideline, § 2N2.1.  First, the base offense level for a second FDC Act offense would be ten (10) , up from the current base offense level of six (6).  Under the Guidelines, a base offense level and various other factors determine the sentence imposed.  Under the FDC Act, first offense regulatory (non-fraud) offenses are misdemeanors with a maximum jail sentence of one (1) year.  In contrast, second offenses are felonies with a three (3) year maximum jail sentence.  The proposed amendment reflects this difference in the FDC Act in the Guidelines. 

Second, the proposed amendment expands the scope of conduct that the Guidelines suggest may warrant an upward departure.  Under the Guidelines, there are certain instances in which the Guidelines indicate to the sentencing court that it may be appropriate to depart upwards or downwards from the sentence otherwise calculated by the Guidelines.  To date, the Guideline applicable to FDC Act non-fraud offenses has limited consideration of such an upward departure based upon death or injury to cases in which death or bodily injury actually resulted.  In the proposed amendment, a sentencing court would be instructed to consider an upward departure in any case in which the offense created a “substantial risk of bodily injury or death” (emphasis added).  Unlike an actual death or bodily injury, which either did or did not occur, the proposed amendment would support an upward departure in any case in which the government could convince the sentencing judge that the offense created a “substantial risk” of such harm.  Based on the government’s historical position in FDC Act regulatory offense cases, one can reasonably assume that the government will routinely invoke the “substantial risk” upward departure.

The Commission declined to adopt the following FDA recommendations:

1.  to amend the Guidelines to explicitly cover human growth hormone (hGH) offenses;

2.  to amend the Guidelines to increase the sentences for Prescription Drug Marketing Act offenses; 

3.  to amend the Guidelines so that the value of any FDC Act regulated product (drug, device, food) would be zero if that product were deemed adulterated or misbranded under the FDC Act.

Absent congressional action, these proposed amendments will become effective on November 1, 2008.

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

Categories: Enforcement