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Federal Court Rules FDA Can’t Restrict Off-Label Marketing by Drug Makers


In a landmark ruling of enormous potential significance but, for now at least, questionable applicability nationwide, a federal district court in New York has held that the Food and Drug Administration (FDA) cannot restrict drug makers’ efforts to market pharmaceuticals for indications not approved by the agency. While doctors are permitted to prescribe drugs for non-FDA-approved (or “off-label”) uses, drug manufacturers themselves have long been prohibited from marketing their products off-label on the theory that such promotion could harm consumers. Patients, the reasoning behind the ban held, might be swayed by advertising into pressing their doctors for prescriptions to treat maladies where there was little scientific evidence supporting the effectiveness and safety of such uses.

On August 7, 2015, however, a federal district court judge sitting in Manhattan ruled that the federal government could not proscribe off-label marketing, citing the First Amendment as the basis of his decision. While misleading commercial speech may generally be barred by the government, truthful commercial speech enjoys greater protection. The court held that off-label marketing constitutes protected commercial speech so long as it is truthful and not misleading.

The implications of this decision are sizable. For years, pharmaceutical companies have faced the specter of heavy government fines for marketing off-label, while the False Claims Act authorized “whistleblowers” within the industry to bring private civil claims (called qui tam actions) for violating the ban. Should off-label marketing be accepted as legal, such enforcement actions and private causes of action will disappear. Consumers are those most likely to suffer, given that drug makers will lose the incentive to seek rigorous scientific support for product uses in soliciting FDA approval. Instead, they will be permitted to bring drugs to market and promote them through billion-dollar ad campaigns so long as those ads are “not misleading”-a far lower bar than the FDA approval process demands.

At present, the trial court’s decision is of limited effect, constituting dispositive law only in the case to which it applies and persuasive authority in other matters even within the same jurisdiction. The precedent on which it was based, however, is a Second Circuit decision that had vacated the conviction of a pharma sales representative who was prosecuted for violating the FDA’s ban on off-label promotion. There, the appellate court extended the First Amendment’s protection of truthful advertising to off-label marketing in the criminal context, which the district court judge above applied in a civil matter. It thus appears likely that, in the Second Circuit at least, a sea change has occurred. Whether courts elsewhere agree remains to be seen.

The lawyers at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner have been protecting the rights of consumers and patients for over 65 years. If you or someone you know has been harmed by a defective product or dangerous drug, please call us today at 713-396-3964 or toll free at 800-594-4884.

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