martes, 11 de octubre de 2016

FDA Law Blog: Court Rejects Prosecution of Pharmacists Due to Lack of Fair Notice in FDC Act

FDA Law Blog: Court Rejects Prosecution of Pharmacists Due to Lack of Fair Notice in FDC Act



Posted: 10 Oct 2016 06:24 PM PDT
By Andrew J. Hull –

There has been an interesting development in the ongoing prosecution of a slew of former officers and employees of the New England Compounding Center (NECC). As you may recall, the NECC was responsible for shipping allegedly contaminated compounded steroid epidural products nationwide, allegedly resulting in widespread sickness and death (see our previous posthere).

Last week, the federal district court in Massachusetts (Stearns, J.) dismissed the indictment as it pertained to two former NECC employees, Kathy Chin and Michelle Thomas. The indictment charged them with felony counts of dispensing drugs into interstate commerce without a valid prescription.  Under 21 U.S.C. § 353(b)(1), a drug is deemed misbranded while held for sale if it is dispensed by a pharmacist without a valid prescription.  The felony charge requires an intent to defraud or mislead.

The controversial aspect of indicting Chin and Thomas is that they were not pharmacists dispensing prescriptions in the way most people would understand that description. Rather, they were actually in charge of the final check of prescription drug packages for accuracy as to name, address, and contents.

The indictment alleged that Chin and Thomas had to know these prescriptions were phony because the patient names were so unlikely, including celebrities, famous athletes, and fictional characters (e.g., “David Letterman,” “Jay Leno,” “Dale Earnhardt,” “Tony Tiger,” “L.L. Bean,” and “Filet O’fish”). The government took the position that their incidental role in checking the packages for the phony prescriptions made them just as guilty of the crime as the pharmacists who dispensed the drugs without a valid prescription.

The court, however, held that the FDC Act did not provide fair notice to the defendants that their activities would constitute “dispensing.” The court noted that the FDC Act does not define the word “dispensing,” and held that the word should be given its meaning in common parlance within the statutory context:

In the world of pharmacology, a pharmacist engages in the act of dispensing when she “fill[s] a medical prescription.” Stedman’s Medical Dictionary (28th ed. 2014).  In other words, a pharmacist dispenses a drug when she acts in her role as a licensed professional authorized to fill (put together) a medical prescription for delivery to a patient.
Order at 8.

Absent the constitutional due process that fair notice provides to defendants informing them that their activities are covered under a criminal statute, the court ruled that the indictment, as it pertained to Chin and Thomas, failed. Specifically, the court held that because the defendants’ conduct was only “incidental” to the activity of dispensing, the FDC Act did not provide them with fair notice that their conduct violated the FDC Act:

Returning to basics, the issue in this case is one of fair notice. Would a reasonable person, even a reasonable pharmacist, understand from the indictment that by matching orders to packages prior to their being shipped, she was criminally liable for participating in the filling of a prescription that she had never approved (or is even alleged to have seen), and as a result was guilty of dispensing (misbranding) the prescribed drug with the intent to defraud?  The answer, as best as I can determine, is that she would not.  Absent allegations of conduct amounting to fair notice of a crime under the [FDC Act], the indictment fails.
Id. at 11-12.

Criminal cases entertaining constitutional due process challenges of fair notice under the FDC Act are rare. See, e.g.Kordel v. United States, 335 U.S. 345, 348-49 (1948); United States v. Zenker, No. 94-50616, 1996 WL 468614 (9th Cir. Aug. 16, 1996).  We could only locate a single case in the long history of the FDC Act that actually dismissed criminal charges under a “fair notice” due process theory. United States v. Geborde, 278 F.3d 926, 932 (9th Cir. 2002) (holding that the FDC Act’s “held for sale” provision did not provide fair notice to a doctor that his conduct of providing friends with homemade (i.e., misbranded) drugs for free was covered under the FDC Act). 

Recent Supreme Court case law has expanded the “fair notice” concept as a check against government regulation and prosecution of people in the regulatory context. See generally FCC v. Fox Television Stations, Inc., 132 S. Ct. 2307 (2012).  We anticipate there may be other challenges to FDA enforcement cases on this ground.