Pharmaceutical Representative’s Off-Label Promotion of Drug Protected by First Amendment, Court Says


GHB3d.pngA court violated the free speech rights of a pharmaceutical sales representative when it convicted him of conspiring to introduce a misbranded drug into interstate commerce. The Second Circuit held in United States v. Caronia, No. 09-5006-cr (2nd Cir., December 3, 2012), that the defendant’s conviction for off-label marketing of the drug Xyrem was based primarily on his speech. It further held that the U.S. Food and Drug Administration’s (FDA’s) off-label regulations were too broad to further the legitimate interest of ensuring safe and consistent drug labeling.

Pharmaceutical companies must obtain FDA approval for specific uses before they may introduce new drugs to the marketplace. Once a drug is in the market, however, the FDA generally does not regulate how physicians promote it to patients. This is partly based on an understanding that doctors may legitimately prescribe drugs for “off-label” uses specific to their patients. The FDA prohibits “misbranding” of a drug, meaning introduction of a drug by a manufacturer with information that differs from its “intended use,” which includes false or misleading information, or uses that could be “dangerous to health.” Caronia at 7, 7 n. 4. The law imposes criminal penalties on pharmaceutical companies and representatives who misbrand drugs, but it does not expressly criminalize promotion of drugs for “off-label” uses.

Xyrem is a product of Jazz Pharmaceutical, formerly known as Orphan Medical. It is a central nervous system depressant used to treat narcolepsy. Its active ingredient, gamma hydroxybutrate (GHB), is also known as a “date rape drug” because larger doses can cause a person to lose consciousness quickly. Its FDA approval included strict limitations, with only two approved uses for narcolepsy patients.