Marketing FDA-approved drugs for off-label uses is protected by the right to free speech, according to a ruling by the U.S. Court of Appeals for the Second Circuit in New York (United States v. Caronia). As a note of explanation, when a drug is approved by the FDA, the FDA approves specific medical uses for that drug and those approved uses are generally included in the drugs labeling. Only uses approved by the FDA can be part of the drug labeling. “Off-label use” means using an FDA-approved drug for a medical problem that is not listed in the drug labeling. Medical doctors are allowed to use FDA-approved drugs for off-label uses, but traditionally, pharmaceutical companies have not been allowed to market those off-label uses.
Alfred Caronia was a sales representative for Orphan Medical, Inc. (“Orphan”), now known as Jazz Pharmaceutical. He was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of the Food, Drug and Cosmetics Act (FDCA), specifically 21 U.S.C. §§ 331(a) and 333(a)(1). According to court documents, he promoted the drug Xyrem for “off-label use,” that is, for a purpose not approved by the FDA.
The FDCA prohibits “misbranding,” or “[t]he introduction or delivery for introduction into interstate commerce of any . . . drug . . . that is . . . misbranded” (21 U.S.C. § 331(a)). According to the FDCA, a drug is misbranded if its labeling fails to bear “adequate directions for use” (21 U.S.C. § 352(f)), which FDA regulations define as “directions under which the lay[person] can use a drug safely and for the purposes for which it is intended” (21 C.F.R. § 201.5.4).
The federal government has won convictions against pharmaceutical companies and their representatives for misbranding based on their off-label promotion (see below). The government’s position is that an FDA-approved drug that is marketed for an unapproved use is misbranded because the labeling of such drug does not include ‘adequate directions for use.’ The government has successfully argued that no set of directions can constitute adequate labeling for drug’s off-label use.
According to Second Circuit in this case:
The government has treated promotional speech as more than merely evidence of a drug’s intended use — it has construed the FDCA to prohibit promotional speech as misbranding itself.
Caronia argues that he was convicted for his speech — for promoting an FDA-approved drug for off-label use — in violation of his right of free speech under the First Amendment. We agree.
“The decision is bad for consumers because they will now be exposed to risks not contemplated by the FDA in giving the drug its approval. Moreover, the decision may be the gateway to mass advertising for off-label uses, thus further enhancing the risks.”
Bad or not, it appears that the momentum in the law is toward more commercial free speech rights. This means that the onus is on the FDA to make sure that patients will not be harmed by the marketing of off-label uses for FDA-approved drugs. As the Second Circuit said in this ruling, there are many ways the FDA can protect patients. We, therefore, urge the FDA to lose no time in dealing with off-label use issues arising from this ruling.
You can contact attorneys Fred Pritzker and Eric Hageman for a free consultation here.
Examples of cases where the federal government got judgments against pharmaceutical companies and/or their sales employees for marketing drugs for off-label uses: Judgment, United States v. GlaxoSmithKline, LLC, 12-cr-10206, (RWZ), ECF Doc. No. 13 (D. Mass. July 10, 2012) (Information, GlaxoSmithKline, No. 12-cr-10206 (RWZ), ECF Doc. No. 1 (D. Mass. July 2, 2012)); Judgment, United States v. Merck Sharp & Dohme Corp., No. 11-cr-10384 (PBS), ECF Doc. No. 30 (D. Mass. May 18, 2012) (Information, Merck, No. 11-cr-10384 (PBS), ECF Doc. No. 1 (D. Mass. Nov. 22, 2011)); Agreed Order of Forfeiture, United States v. Abbott Labs., No. 12-cr-26 (SGW), ECF Doc. No. 7 (W.D. Va. May 7, 2012) (as a result of the guilty plea to the Information (Information, Abbott, No. 12-cr-26 (SGW), ECF Doc. No. 5-1 (W.D. Va. May 7, 2012))); Judgment, United States v. Allergan, Inc., No. 10-cr-375 (ODE), ECF Doc. No. 20 (N.D. Ga. Oct. 7, 2010) (Information, Allergan, No. 10-cr-375 (ODE), ECF Doc. No. 1 (N.D. Ga. Sept. 1, 2010)).