Drugs - Food, Drug and Cosmetic Act Violations

Favorable and Noteworthy Decisions in the Supreme Court and Federal Appellate Courts

United States v. Caronia, 703 F.3d 149 (2d Cir. 2012)

The Second Circuit holds that prosecutions based on “off-label” promotion violates the First Amendment. The defendant’s were charged with promoting the off-label use of certain drugs (i.e., promoting the use of a drug that was approved by the FDA for one purpose, but advocating its use for another purpose). While it is perfectly legal for a doctor to prescribe a drug approved for a purpose other than the use for which the FDA approved the drug, it is not legal for the drug manufacturer to promote the drug’s use for any purpose other than the approved purpose. The Second Circuit held that this violates the First Amendment.

United States v. Smith, 573 F.3d 639 (8th Cir. 2009)

On-line pharmacy prosecution. Discussion of relationship between doctor’s reasonable exercise of judgment and the mis-branding regulations in 21 C.F.R. § 1306 and other issues related to on-line pharmacies.

United States v. Goldberg, 538 F.3d 280 (3rd Cir. 2008)

The defendant was a veterinarian who sold drugs to animal owners, contending that they qualified as “vets” under state law and could receive drugs that he sold to them. The decision contains lengthy anlyses of § 331(k) (misbranding) offenses. The court concluded that the defendant was guilty of misbranding, but only a misdemeanor, because there was no intent to defraud. He did what he did openly and without deception.

United States v. Geborde, 278 F.3d 926 (9th Cir. 2002)

Prior to the time that GHB was outlawed as a controlled substance, the defendant manufactured the drug and gave it to a minor, who died. The government prosecuted him for violating 21 U.S.C. § 331(p), operating an unregistered drug manufacturing facility. This is a misdemeanor, unless the government proves an intent to defraud (i.e., an intent to defraud by failing to register), in which case the defendant may be prosecuted for a felony. There was no proof of this intent, however, and the defendant’s felony conviction was reversed. In addition, the government charged the defendant with a violation of 21 U.S.C. § 331(k), which makes it a federal crime to misbrand a drug that is “held for sale.” However, the drug in this case was not “held for sale” and the convictions on these counts, too, were reversed.

United States v. Watkins, 278 F.3d 961 (9th Cir. 2002)

The felony offense of misbranding under the Food, Drug and Cosmetic Act (21 U.S.C. § 333(a)(2)) requires proof that the misbranding was “material.” It is not enough to simply prove that the statement is false.