Off-label drug promotion and marketing yields significant penalties: Part 2 (Misbranding in interstate commerce)

Misbranding can also occur when a product is “held for sale after shipment in interstate commerce.”Say for example, that a business wants to distribute HCG or another drug and is stocking an inventory, yet has its own website making claims about the HCG. This raises both FDA and FTC issues.

There are at least two ways to violate the misbranding proscription of the FDCA: (1) introducing a misbranded drug into interstate commerce, and (2) doing an act which results in the drug being misbranded, while the drug is being “held for sale after shipment in interstate commerce.” The second category—which was at issue in Evers—triggers the question as to whether criminal liability can arise for marketing off-label uses, even if an entity is not involved in manufacturing or distribution. (See Off-label drug promotion and marketing yields significant penalties: Part 1 (Amgen settlement)).

U.S. v. Caronia involved a misbranding charge against a pharmaceutical sales representative who promoted a prescription sleep medication to a physician for fibromyalgia, muscle disorders, chronic pain, and other off-label uses. The representative argued that when he marketed the drug for off-label uses, the drug was not being “held for sale … after shipment in interstate commerce” within the meaning of the misbranding statute (subsection (k)), because the drug “was dispensed only via a central pharmacy … and shipped directly to the consumer.” The trial court disagreed, and determined that the drug was indeed being “held for sale” during the time the manufacturer promoted off-label uses, because the centralized pharmacy acted as a warehouse to store the drug. The court stated:

Pursuant to the FDCA, manufacturers are restricted from marketing so-called ‘off-label’ (i.e., non-FDA approved) uses of a drug. Such off-label marketing results in the drug being ‘misbranded’ in violation of the statute.

Even more significantly, the court noted that a sales representative of the manufacturer can be charged with conspiracy to misbrand a drug, in violation of the FDCA and the federal conspiracy statute.

On appeal, the Second Circuit vacated the criminal conviction of the sales representative, ruling: “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns…. [and’ the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” (Slip. op. 26, 51). Notably, the Second Circuit’s ruling relied on the First Amendment to trump FDA concerns. The Second Circuit noted: “The government has repeatedly prosecuted — and obtained convictions against — pharmaceutical companies and their representatives for misbranding based on their off-label promotion.” This is because “promotional statements by a pharmaceutical company or its representatives can serve as proof of a drug’s intended use.” However, the sales rep was convicted merely for off-label promotion, and according to the Second Circuit, this would not be enough; rather, such promotion would have to be used to show intended use. Thi sis because the “FDCA defines misbranding in terms of whether a drug’s labeling is adequate for its intended use, and permits the goverment to provie intended use by reference to promotional statements.” (p. 32)

The Second Circuit explained that it was construing the FDCA so as to avoid an unConstitutional restriction on free speech:

We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDAapproved prescription drugs. Our conclusion is limited to FDA-approved drugs for which off-label use is not prohibited, and we do not hold, of course, that the FDA cannot regulate the marketing of prescription drugs. We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. (p. 51)

In U.S. v. Torigian Laboratories, Inc., the Court stated: “All articles held for purposes other than personal consumption … are deemed held for sale under the Act.” And in Torigian, articles stored in laboratories were considered “held for sale … after shipment in interstate commerce” for purposes of the misbranding provision in (k). Finally, in Kordel v. U.S., consistent with the language Evers concerning the reach of subsection (k), the U.S. Supreme Court stated that subsection (k) “has a broad sweep, not restricted to those who introduce or deliver for introduction drugs in interstate commerce.” These cases suggest that courts may view misbranding broadly in terms of the chain of individuals or entities involved with the drug.

Although FDA enforcement actions typically have targeted manufacturers and distributors, marketing and promotion by others of off-label uses could conceivably be considered misbranding. For example, the FDA does not distinguish distribution from promotion in warning letters involving unsupported claims for human growth hormone (HGH). And in In re Actimmune Marketing Litigation, a U.S. District Court stated: “The FDCA, through a convoluted series of statutory provisions and regulations, makes it unlawful for any person to advertise, promote or market a drug off-label.” (emphasis added)

The FDA has attempted to resolve the conflict between physician interest in off-label uses and the FDCA’s prohibition on pharmaceutical companies’ promotion of off-label information. In this vein, the FDA has issued several Guidance Documents addressing restrictions on the promotion of off-label uses and industry-supported CME programs. However, these documents leave the FDA’s position still murky, and have resulted in First Amendment challenges. Given confusion over the legal authority of prescription drug manufacturers to promote scientific information concerning off-label use of their products, it is likely that FDA enforcement policies regarding advertisers and promoters other than manufacturers will be similarly inconsistent.

Thus, if you are someone other than a manufacturer or distributor – i.e., an affiliate who merely steers the individual to a drug (such as, for instance HCG) – it is nonetheless worth securing clear legal advice regarding your potential FDA legal exposure.

For more information, contact the Cohen Healthcare Law Group. Our FDA legal team is experienced with misbranding and other FDA legal issues.

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