t from the beginning was aimed at marketing Stratus to deliver Kenalog rather than saline.” With respect to design, the evidence reflected that the size of Stratus’s pores had been calibrated to accommodate Kenalog’s specific viscosity – meaning that Stratus did not even work to deliver saline, which is much less viscous and would rapidly seep out. With respect to sales, the government introduced evidence that Stratus “was promoted with a sales strategy devised to get physicians to associate Stratus with Kenalog and consider using it for drug delivery.” For example, sales trainees were not taught or given marketing materials for Stratus describing benefits of use with saline, and instead focused on the off-label uses related to Kenalog.After a jury trial, Acclarent’s former CEO and former vice president of sales were convicted of 10 misdemeanor counts for distributing an adulterated and misbranded device by failing to submit a required premarket notification under 21 U.S.C. §§ 331(a), 333(a)(1), 351(f) and 352(o). The defendants challenged their convictions on appeal, arguing (among other things) that the convictions violated the First and Fifth Amendments.First Amendment does not preclude use of speech as evidence of intended useThe defendants challenged the government’s use of their promotional speech as evidence to support a misbranding violation, arguing that such use effectively criminalizes the speech itself in violation of the First Amendment.In 1993, the Supreme Court ruled in Wisconsin v. Mitchell that the First Amendment does not generally apply to the “evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” However, the Facteau defendants relied on a 2012 Second Circuit ruling (US v. Caronia), where the court held that a misbranding conviction violated the First Amendment. In that case, “the prosecution repeatedly argued that [the defendant] engaged in criminal conduct by promoting and marketing the off-label use of an FDA-app

ts label describes another.So we read the Marschall case and its treatment of misbranding with some interest. The defendant was a “naturopathic doctor” (which is new to us, but apparently is a licensed professional who treats patients using mainly natural remedies) who had a prior misdemeanor conviction for selling misbranded drugs. Id. at *2. That is a key fact, because when he did it again, the government was able to charge him with a felony under a provision of FDCA reserved for recidivists. (By the way, although not material to the analysis, the doctor was convicted of selling a “Dynamic Duo” of substances with no active pharmaceutical ingredients, to help prevent, among other things, COVID-19. Why is it always something about COVID-19?).There are two ways to commit a misbranding felony. One is to violate Section 331 “with the intent to defraud or mislead”—a formulation of scienter that we all recognize from law school. The second is to violate Section 331 with a prior conviction. 21 U.S.C. § 333(a)(2). The latter is where the government got the defendant in Marschall.The upshot is that the recidivist clause of Section 333(a)(2) does not expressly include the element of scienter, and the Ninth Circuit was unwilling to imply one. Sure, there is a longstanding presumption that criminal laws intend to require that a defendant has a culpable state of mind. But the government rebutted that presumption here. First, the statute defines the recidivist version of the misbranding felony by reference to a prior offense that does not itself require scienter, which is allowed for “statutes that regulate potentially harmful or injurious items.” In other words,Congress has dispensed with the normal requirement of scienter and has instead “impose[d] a form of strict liability through statutes that do not require the defendant to know the facts that make his conduct illegal.” [citations.] Section 333(a)(1), which makes it a misdemeanor to introduce misbranded or adulterated drugs into interstate com

This blog post focuses on the Commission’s proposal regarding the appropriate base level offense for a person who is convicted of knowingly and intentionally adulterating a drug under a newly enacted provision of the FDC Act. As you may recall from HPM’s earlier detailed analysis, section 716 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144 (July 9, 2012), added a new subsection to section 303(b) (21 U.S.C. § 333(b)) of the FDC Act which reads as follows:(7) Notwithstanding subsection (a)(2), any person that knowingly and intentionally adulterates a drug such that the drug is adulterated under subsection (a)(1), (b), (c), or (d) of section 501 and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both.Effectively, this means that the maximum criminal penalties associated with this conduct are much steeper than for violations of most other sections of the FDC Act.

24) 21 U.S.C. § 331(a), (c), (g), (k) (emphases added). 25) 21 U.S.C. § 333(b) (If any person “commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.”). 26) Id. § 333(a).

The standard felony provision under the FDCA authorizes 3 years imprisonment and a $10,000 fine, but the enhanced penalty is 10 years imprisonment and a $250,000 fine. See 21 U.S.C. § 333(a)(2) (establishing general penalties for violations of the FDCA committed with the intent to mislead or defraud and second offenses under the FDCA); see also 21 U.S.C. § 333(b)(6) (establishing enhanced penalties for manufacturers and importers who knowingly fail to comply with Section 804(e)). Notably, the Proposed Rule explicitly emphasizes that “the obligations on manufacturers” are enforceable under Section 301(aa).

.8Park, 421 U.S. at 673.9 21 U.S.C. § 331(a), (b), (k) (2016).10 21 U.S.C. § 333(a)(1) (2015).11 21 U.S.C. § 333(a)(2).12Id.13 Section 331 of the FDCA lays out dozens of prohibited acts, including (1) introducing or delivering into interstate commerce an adulterated or misbranded drug or device, (2) making or dispensing counterfeit drugs, (3) altering or removing any food or drug label, if the product is for sale and removing the label results in the product being adulterated or misbranded, (4) operating a food processing or holding facility with foreseeable hazards, or the owner fails to implement and monitor preventative controls.14See United States v. Park, 421 U.S. 658 (1975) (finding the CEO of a national grocery store chain liable for food safety violations at a company warehouse, even though the CEO was generally unaware of the violations); United States v. Purdue Frederick Co., Inc., 495 F. Supp. 2d 569 (W.D. Va. 2007) (holding that three executives who were not personally aware of Purdue’s misbranding of OxyContin pleaded guilty to violating the FDCA). See also The Cr

By way of example, only, the Acknowledgment form asserts that entities and individuals that received adulterated and misbranded drugs, or deliver such drugs violate the law and can face criminal penalties. The form omits any discussion of Section 303(c) of the Act (21 U.S.C. 333(c)), which specifically states that the penalties of section 303(a)(1) of the Act (21 U.S.C. 333(a)(1) do not apply in certain circumstances. While one can understand why OCI might want to utilize such a form to achieve “voluntary” compliance, regulated persons and entities should think carefully about the consequences of signing this form.

At least since United States v. Park was decided by the United States Supreme Court in 1975, there has been substantial debate about the level of responsibility at a corporation that should subject an individual to a criminal prosecution. The government’s position has been understated but basically consistent since this writer was in the government between 1973 and 1992: Any person, no matter what his/her level of responsibility, is theoretically subject to criminal prosecution under 21 U.S.C. 333(a)(1) because: (1) that person directly committed a prohibited act under 21 U.S.C. 331; (2) the person “caused” a prohibited act to have occurred or aided and abetted in such an act by his/her employer; or (3) the person was in a position of authority to prevent Section 331 violations from occurring. On January 14, 2016, the United States Court of Appeals for the Eighth Circuit affirmed the convictions of three individuals convicted of selling misbranded synthetic drugs.

Additionally, what are the impacts of these decisions on the False Claims Act? Finally, the question remains to what extent drug and device manufacturers will change their promotional strategies, and the degree to which the FDA will be willing to work with the regulated industry to ensure promotional practices are truthful and not misleading.26 Off-label promotion is an evolving area of law fraught with opportunities and pitfalls, including substantial fines and criminal sanctions.1 Amarin Pharma, Inc. v. U.S. Food and Drug Administration, 1:15-cv-03588-PAE (SDNY 2015).2 See 21 U.S.C. § 333(a)(1).3 Id.4 See 21 U.S.C. § 333(a)(2)5 See 21 U.S.C. § 352(f).6 21 C.F.R. § 201.5.

By taking these steps, physicians can reduce the likelihood that they are purchasing illegal medications.Endnotes1 21 USC §§ 333(a), 352(o) (2012).2See Press Release, FDA, FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies (June 27, 2013) (available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358794.htm).