Tip of the Iceberg II: How the Intended-Uses Principle Produces Medical Knowledge and Protects Liberty
34 Pages Posted: 27 Jun 2017 Last revised: 12 Jan 2018
Date Written: January 12, 2018
In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the FDA’s premarket approval process – and the restrictions on “off-label” promotion in particular – caused the drug company to produce and disseminate knowledge about safety and efficacy for new uses. The law successfully resolved the collective action problem of producing knowledge, even while the law protected the liberty of individual doctors and patients to use the product in ways that the FDA had not considered.
In the second part of the paper, we show a range of other domains, in which Congress similarly uses the actor’s intent, shown by the actor’s own speech, to narrowly define proscribed conduct. By tailoring the law in this way, Congress achieves policy goals while minimizing the infringement of liberty. This broad review helps advance our understanding of both food and drug law as well as the First Amendment doctrine. The law’s use of speech as evidence of intent can produce knowledge while protecting liberty.
Keywords: First Amendment, FDA, pre-market approval, drugmakers, off-label, regulation, commercial speech, regulatory regimes
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