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Off-Label Marketing and the First Amendment
Prosecutions for “off-label marketing” by manufacturers have become an important component of the government's health care initiative. “Off-label” usage of prescription drugs and medical devices refers to using a product for a purpose that is not specified in the labeling approved by the Food and Drug Administration (FDA). Manufacturers are prohibited from promoting off-label uses of their products, but health care providers may prescribe or use them as they choose, whether or not the use fits within the FDA-approved “label.” 21 U.S.C. ' 396.
Government fines and criminal prosecutions against manufacturers for promoting “off-label” uses have surged, especially for pharmaceuticals. In 2009 alone, the Department of Justice (DOJ) announced the largest health care fraud settlement in U.S. history ' a $2.3-billion settlement with Pfizer arising from the off-label promotion of certain pharmaceutical products. Eli Lilly, Bristol-Myers Squibb, and Novartis have also entered into multi-million-dollar settlements. AstraZeneca agreed in April 2010 to a $520 million settlement in connection with off-label marketing.
Pharmaceutical and medical device manufacturers have argued that FDA restrictions on off-label promotion infringe their First Amendments rights. While First Amendment defenses are difficult, two recent cases have placed this issue back in the spotlight. United States v. Harkonen, No. C 08-00164 MHP, 2009 WL 1578712 (N.D. Cal. June 4, 2009), a criminal prosecution, and Allergan, Inc. v. United States, No. 09-1879 (JDB) (D.D.C. Oct. 1, 2009), a civil case that is awaiting decision. Further, the expansive interpretation of the First Amendment protections in recent Supreme Court decisions, albeit in different settings, may further re-energize this defense.
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