Off-Label 'Promotion' May Not Be Merely Commercial Speech

2015 ◽  
Author(s):  
Jennifer L. Herbst
Keyword(s):  
Off Label ◽  
Commercial Speech

Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection

2011 ◽  
Vol 37 (2-3) ◽  
pp. 315-357 ◽  
Author(s):  
Coleen Klasmeier ◽  
Martin H. Redish
Keyword(s):  
Prescription Drugs ◽  
Medical Profession ◽  
Scientific Data ◽  
Efficacy And Safety ◽  
Medical Purpose ◽  
Off Label Use ◽  
Off Label ◽  
Commercial Speech ◽  
Hand Off ◽  
The One

In order to protect the nation from harmful or worthless drugs and devices, the Food and Drug Administration (FDA or the Agency) is legislatively authorized to restrict the sale of prescription drugs or medical devices to those whose efficacy and safety have been reviewed and approved by the Agency. Drugs and devices are approved for a specific medical purpose. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such “off-label” treatments have proven to be essential to the successful treatment of some very serious illnesses.In these off-label situations, the FDA is faced with a dilemma. On the one hand, off-label use of prescription drug and devices gives rise to a series of major problems for the FDA. While the drug and devices in question have been vetted and approved by the FDA for their designated purpose, at no point has the FDA reviewed the supporting scientific data to determine efficacy for the off-label purpose.

scholarly journals The Indirect Consequences of Expanded Off-Label Promotion

2018 ◽  
Author(s):  
Patricia Zettler
Keyword(s):  
Decision Making ◽  
First Amendment ◽  
Prescription Drugs ◽  
Off Label ◽  
Commercial Speech ◽  
High Profile ◽  
Federal Food ◽  
Legal Challenges ◽  
Drug Promotion ◽  
The U.S

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion—protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority.Citation: Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, 78 Ohio St. L.J. 1053 (2017).

Commercial Speech and Off-Label Drug Uses: What Role for Wide Acceptance, General Recognition and Research Incentives?

2011 ◽  
Vol 37 (2-3) ◽  
pp. 258-277 ◽  
Author(s):  
Margaret Gilhooley
Keyword(s):  
Controlled Study ◽  
Off Label Use ◽  
Off Label ◽  
Commercial Speech ◽  
Abuse Case ◽  
Drug Companies ◽  
Number Of Patients ◽  
Constitutional Protections ◽  
Research Incentives ◽  
Label Use

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures.Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide “truthful information” to doctors about “widely accepted” off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to “widely accepted” uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks.A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies.The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.

The Ban on “Off-Label” Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis against False or Misleading Commercial Speech?

2011 ◽  
Vol 37 (2-3) ◽  
pp. 278-298 ◽  
Author(s):  
Kate Greenwood
Keyword(s):  
First Amendment ◽  
Legislative History ◽  
The Public ◽  
Off Label ◽  
Commercial Speech ◽  
Pharmaceutical Manufacturers ◽  
Drug Promotion ◽  
Pharmaceutical Promotion ◽  
History Of ◽  
The Government

Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal—and beneficial—products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they “usually rest solely on the offensive assumption that the public will respond ‘irrationally’ to the truth.” The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on “truthful speech to physicians” but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.

Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases

2021 ◽  
Author(s):  
Sheng Liu ◽  
Michelle M. Mello ◽  
Aaron S. Kesselheim
Keyword(s):  
United States ◽  
First Amendment ◽  
Study Cohort ◽  
Circuit Court ◽  
Off Label ◽  
Commercial Speech ◽  
Pharmaceutical Manufacturers ◽  
Drug Promotion ◽  
Federal Circuit ◽  
Case Outcome

Abstract Context: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotion was protected under the First Amendment, threatening government enforcement in this area. Methods: The authors extracted cases from the WestLawNext database that mentioned Caronia from 2012 to 2019. They collected information about plaintiff, procedural history, product and manufacturer involved, and case outcome. Cases were categorized as either “follows,” “does not follow,” or “distinguishes” from Caronia. The authors qualitatively reviewed the full text of each case to verify whether Caronia was given substantive discussion for perceptions of off-label promotion, application of commercial speech rights, and how courts interpreted Caronia. Findings: Among 42 cases in the study cohort, 22 (52%) followed Caronia's core holding that truthful, non-misleading off-label promotion was not actionable under FDA rules. By contrast, 20 cases (48%) treated Caronia negatively, either declining to follow (9 cases) or distinguishing it (11 cases). Conclusions: Enforcement on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.

Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech

2011 ◽  
Vol 37 (2-3) ◽  
pp. 225-257 ◽  
Author(s):  
Aaron S. Kesselheim
Keyword(s):  
Public Health ◽  
Prescription Drugs ◽  
Drug Label ◽  
Safety And Efficacy ◽  
Off Label ◽  
Commercial Speech ◽  
The Past ◽  
Health Goals ◽  
The Subject ◽  
The Universe

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use.

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