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Hidden Truth: The Perils and Protection of Off-Label Drug and Medical Device Promotion

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Hidden Truth: The Perils and Protection of Off-Label Drug and Medical Device Promotion

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What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it? Sometimes, there is nothing to do but hope. Very often, though, your doctor will be able to prescribe a drug or medical device that has been approved by the Food and Drug Administration (FDA) for a different condition. This practice, called “off-label” prescribing, is perfectly legal, commonly practiced within the medical community, viewed as an essential component of good medical care, and offers greater choice in treatment options for millions of American patients. It is not without controversy, however.

Because the safety and efficacy of off-label uses have not been certified by the FDA, some in government and the public health community have long criticized the practice.  And the FDA has long forbidden drug and device makers from disseminating most information about off-label uses, often making it difficult for doctors and their patients to learn about important therapeutic options.  

No federal statute explicitly forbids manufacturers from promoting or otherwise disseminating information about off-label uses of their drugs and devices. The FDA has, however, extended its authority over product labeling to encompass manufacturers’ speech in other contexts—including print and broadcast advertisements, brochures and pamphlets, websites, conferences and seminars, and face-to-face communication.  The agency bars nearly all speech promoting an off-label use regardless of its veracity, and vigorously enforces this restriction even when the information is not being broadcast to lay audiences, but is provided directly to physicians with sophisticated medical training. 

Ironically, physicians and laymen not paid by a drug or device’s manufacturer are free to tout the benefits of off-label uses in any way and to any listener. Doctors are free, and indeed are often encouraged by the federal government, to prescribe drugs and devices for off-label uses.  But as legal scholars have noted, if two physicians were to provide identical truthful and non-misleading information about off-label uses to an identical audience, one of them can be hailed as a medical pioneer and the other convicted of a federal crime solely on the basis of the second doctor’s financial ties to a drug or medical device com-pany.  Naturally, this inconsistency has raised questions about the constitutionality of the FDA’s treatment of off-label promotion.

Commercial speech is afforded less constitutional protection than pure political or scientific speech. However, the First Amendment forbids the government from regulating truthful and non-misleading commercial speech about lawful conduct in a manner that is more restrictive than necessary to achieve a substantial governmental interest.  The FDA insists that its bar on off-label promotion is necessary to achieve three interrelated governmental interests: protecting public health through its certification of drug and medical device safety, preserving the integrity of the drug and device approval process, and ensuring that physicians and patients do not receive inaccurate or biased information that may influence prescribing decisions.  

If manufacturers may promote medical products for off-label uses, the argument goes, there is no incentive for them to seek approval for these uses. Thus, the agency has no occasion to evaluate the scientific support for such claims, and physicians and their patients may be persuaded to use products that are unsafe or ineffective. FDA and other supporters of the ban recount sordid stories of snake oil salesmen peddling approved products for off-label uses with unproven, exaggerated, or fraudulent health claims, and they argue that eliminating the ban would open the floodgates for such objectionable conduct.

Section I of this paper examines the convention of off-label prescribing, its role in the practice of medicine, and its broad support within the medical community. It also sets out some of the pros and cons of the practice. Section II discusses the evolution of the Food, Drug and Cosmetics Act and the FDA’s role in the drug and device approval process. 

Section III turns specifically to the regulation of medical product labeling and advertising, and discusses FDA’s regulation of off-label speech. In particular, that section examines Congress’s and the agency’s effort to carve out limited exemptions for certain types of off-label speech, and it introduces a discussion of the treatment by federal courts of off-label speech restrictions. Section IV examines three recent court challenges to the off-label promotion ban, one of which was still on-going at the time of publication. 

Section V discusses the scope of permissible commercial speech regulation and analyzes the constitutionality of off-label speech restrictions in light of applicable case law. It finds that the FDA’s current ban on off-label promotion is unconstitutional, but suggests less burdensome alternative restrictions that likely would pass constitutional muster while still advancing the government’s asserted interests.