American Journal of Law & Medicine

Articles from Vol. 37, No. 2/3, 2011

Can Speech by FDA-Regulated Firms Ever Be Noncommercial?
I. INTRODUCTIONFor over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products.1 The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and...
Commercial Speech and Off-Label Drug Uses: What Role for Wide Acceptance, General Recognition and Research Incentives?
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...
No Need for More Regulation: Payors and Their Role in Balancing the Cost and Safety Considerations of Off-Label Prescriptions
I. INTRODUCTIONIn 2009, health care expenditures in the United States totaled $2.5 trillion and accounted for almost eighteen percent of the national Gross Domestic Product (GDP).1 Rising health care costs are an increasing concern in the national health...
Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech
I. INTRODUCTIONOff-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...
Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection
I. INTRODUCTIONIn 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...
Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications
1. INTRODUCTIONThe pharmaceutical industry is a competitive business. Companies spend billions of dollars researching and developing new drugs.1 Many drugs never make it to market. For the limited drugs that make it through the experimental, regulatory,...
The Ban on "Off-Label" Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis against False or Misleading Commercial Speech?
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 Commercial Speech Doctrine in Health Regulation: The Clash between the Public Interest in a Robust First Amendment and the Public Interest in Effective Protection from Harm
I. INTRODUCTIONHistorically, government has been given more leeway when invoking its interests in safeguarding the public health than when asserting other state interests. Thus, for example, when considering a constitutional challenge to mandatory smallpox...
The Money Blind: How to Stop Industry Bias in Biomedical Science, without Violating the First Amendment
The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions-the decisions that drive an increasingly large portion of the American...
You Can't Say That on Television: Constitutional Analysis of a Direct-to-Consumer Pharmaceutical Advertising Ban
I. INTRODUCTIONIn one year, you will watch roughly sixteen hours of pharmaceutical advertisements.1 Sometime during those sixteen hours, you may recognize in yourself the symptoms portrayed in the advertisements. You may even wonder whether you would...
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