Harsh sentences coming for strict liability FDA misdemeanor offense

Mar 29, 2011   

The FDA has recently expressed that it intends to bring more criminal prosecutions for strict liability offenses under the Food, Drug & Cosmetic Act (FDCA) under the “Park” Doctrine. As we previously discussed, the FDCA makes it a criminal misdemeanor to violate the FDCA even if a person had no knowledge of a violation, did not commit fraud, and did not intend to violate the law. This is known as a “strict liability” misdemeanor, as opposed to criminal offenses that require a defendant to knowingly commit an offense.

On January 19, 2011, the United States Sentencing Commission (The Commission) issued a Federal Register Notice regarding amendments to the Federal Sentencing Guidelines which would require many persons convicted and sentenced under the misdemeanor, strict liability provisions of the FDCA to be sentenced under more serious guidelines for fraud rather than for regulatory offenses. The impact of these proposed changes is that strict liability, or “Park” misdemeanor offenses could receive the same guideline score as a felony offense requiring intent to defraud, and consequently a similar sentence, i.e. prison terms. The Commission proposal would amend the Guidelines with regard to “persons convicted of Federal health care offenses involving Government health care programs.” As currently noticed, the proposal would not contain a limitation with regard to the health care offenses and government health care programs to which increased sentences would apply. Therefore, they would apply to strict liability misdemeanors under the FDCA that involve health care offense and government health care programs.

What is left open to debate is how directly connected to a government health care program a FDCA offense must be to trigger the proposed guidelines. As seen from recent “off-label” use cases, the Department of Justice believes that such uses implicate government health care programs. As such, a wide swath of proscribed conduct under the FDCA regarding manufacturing, adulteration and misbranding may come under the purview of the new proposed Guidelines. Under the current proposals, there may be considerable litigation regarding the applicability of the enhanced Guidelines to strict liability misdemeanors if there is not further clarification or amendment by the Commission after the comment period.

Lawyers at Fuerst Ittleman concentrate their practices on defending individuals and corporations accused of FDCA offenses in administrative, civil and criminal cases. If you are in need of legal advice regarding the FDCA, criminal investigations or prosecutions regarding the FDA or require guidance on complying with the FDCA, Fuerst Ittleman can assist you.