Comment: First Amendment and Consumer Privacy Concerns in the Pharmaceutical Industry: Analyzing the Courts Protection on Commercial Speech Regarding Pharmaceutical Marketing, and How the Courts Have Expanded This Interpretation to Off Label Marketing and Pharmacy Compounding and the Results These Decisions Have on Consumer Privacy

2014 ◽  
Author(s):  
Ronald Bakay
Keyword(s):  
Pharmaceutical Industry ◽  
First Amendment ◽  
Pharmaceutical Marketing ◽  
Privacy Concerns ◽  
Consumer Privacy ◽  
Off Label ◽  
Commercial Speech

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).

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.

Mobile Commerce and Consumer Privacy Concerns

2013 ◽  
Vol 53 (4) ◽  
pp. 31-38 ◽  
Author(s):  
Ruidong Zhang ◽  
Jim Q. Chen ◽  
Ca Jaejung Lee
Keyword(s):  
Mobile Commerce ◽  
Privacy Concerns ◽  
Consumer Privacy

Usage of smartphone for financial transactions: from the consumer privacy perspective

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Sheshadri Chatterjee ◽  
Ranjan Chaudhuri ◽  
Demetris Vrontis ◽  
Zahid Hussain
Keyword(s):  
Structural Equation ◽  
Service Providers ◽  
Equation Modeling ◽  
Moderating Effects ◽  
Content Type ◽  
Privacy Concerns ◽  
Consumer Privacy ◽  
Novel Approach ◽  
Privacy Calculus ◽  
Financial Transactions

Purpose This study aims to empirically examine how consumer privacy concerns (CPC) impact smartphone usage for financial transactions. The study also investigates the moderating impact of regulations on this action. Design/methodology/approach With the inputs from literature and related privacy theories, a theoretical model was developed. The model was later empirically validated using the partial least squares structural equation modeling technique with 367 respondents from India. Findings The study finds that CPC significantly impacts on consumer behavior in using smartphones for financial transactions. The study also highlights that regulation has a moderating impact on consumer usage of smartphones for financial transactions. Research limitations/implications This study provides valuable inputs to smartphone service providers, practitioners, regulatory authorities and policymakers on appropriate and secure usage of smartphones by consumers, ensuring privacy protection while making financial transactions. Originality/value This study provides a unique model showing the antecedents of CPC to impact the behavioral reaction of smartphone users mediated through the ingredients of privacy calculus theory. Besides, this study analyzes the moderating effects of regulation on the use of smartphones for financial transactions. This is also a novel approach of this study.

scholarly journals Can Speech by FDA-Regulated Firms Ever Be Noncommercial?

2011 ◽  
Vol 37 (2-3) ◽  
pp. 388-421
Author(s):  
Nathan Cortez
Keyword(s):  
Drug Administration ◽  
First Amendment ◽  
Free Speech ◽  
Regulatory Scheme ◽  
Commercial Speech ◽  
Federal Food ◽  
Regulated Firms ◽  
The Supreme Court ◽  
Regulated Firm ◽  
Free Speech Rights

For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and Cosmetic Act “depends on the use of words” and that its requirements can “explicitly limit speech.” For seventy years, the FDA had little reason to worry about First Amendment constraints. But since 1976, when the Supreme Court reversed its longstanding position that the First Amendment does not protect commercial speech, the Agency has had to confront–perhaps more than any other federal agency–the free speech rights of regulated firms.But how far do those rights extend, and what room do they leave for regulators like the FDA? The answer largely depends on another question: Is the speech commercial or noncommercial? The distinction is paramount. If speech by a regulated firm is commercial, then the FDA can ensure that it is not false or misleading; the Agency can require or compel certain speech; it can impose prior restraints; and it can even limit truthful speech, all within certain parameters.

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