The U.S. Food and Drug Administration (FDA) recently issued draft revisions of pharmaceutical industry guidelines regarding “off-label” promotion of drugs. “Off-label” refers to information about uses of a drug that have not been formally approved by the FDA and are not included in its approved labeling. The agency has treated off-label promotion as “misbranding,” which can carry both civil and criminal penalties under the Food, Drug, and Cosmetics Act (FDCA). The Second Circuit Court of Appeals struck down the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, finding that the off-label promotion rule violated his First Amendment right to free speech. United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012). The FDA’s proposed revisions, published in the Federal Register at 79 FR 11793 (Mar. 3, 2014), seek to apply a narrower set of restrictions on off-label promotion.
The FDCA generally prohibits “misbranding” of an approved drug. In a “Guidance for Industry” document published in January 2009, the FDA addressed the distribution of medical literature and other scientific publications regarding off-label uses of approved drugs. The FDA has strict labeling requirements for all approved drugs, including risks of side effects and complications and instructions for use. Off-label marketing of a drug, the FDA stated in the guidance document, constitutes unlawful misbranding of a drug because the drug’s label does not include “adequate directions for use,” as required by the FDCA. 21 U.S.C. § 352(f), 21 C.F.R. § 201.100(c)(1).
The defendant in Caronia was charged with conspiracy to introduce a misbranded drug, and introducing a misbranded drug, into interstate commerce. 21 U.S.C. § 331(a). If a defendant had the “intent to defraud or mislead,” the offense carries a maximum penalty of three years in prison, a $10,000 fine, or both. 21 U.S.C. § 333(a)(2). The case involved Xyrem, a central nervous system depressant with only two FDA-approved uses. The drug contains GHB, a powerful depressant commonly known as the “date rape drug,” making it one that the FDA closely watches.
A jury found the defendant guilty of the conspiracy charge. On appeal, the defendant argued that restrictions on “truthful and non-misleading promotion” of approved drugs are unconstitutional. Caronia, 703 F.3d at 160. The Second Circuit found that the defendant’s speech was the sole issue in the government’s case. The FDA’s interpretation of the FDCA’s rules for off-label marketing, the court found, was not narrowly-tailored to a government interest, and therefore violated the defendant’s free-speech rights.
The new draft guidelines reiterate the FDA’s concerns over the impact on public health of promoting uses for drugs and medical devices that have not gone through the formal review and approval process. It took into account, however, the Second Circuit’s remarks in Caronia about “truthful and non-misleading” information. The guidelines continue to allow distribution of peer-reviewed scientific and medical journal articles and texts by drug manufacturers, and the revisions add clinical practice guidelines. The FDA will take the “truthful and non-misleading” issue into account, however, in determining whether it believes a manufacturer intends to misbrand a drug.
The pharmacy error injury attorneys at Lebowitz & Mzhen can assist people in Maryland and Washington DC who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule a free and confidential consultation to discuss your case, please contact us today online or at (800) 654-1949.
Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices (PDF file), U.S. Food and Drug Administration, February 2014 (source)
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