TY - JOUR
T1 - Tip of the Iceberg II
T2 - How the intended-uses principle produces medical knowledge and protects liberty
AU - Robertson, Christopher
AU - Laurion, Victor
N1 - Publisher Copyright:
© Joe Christenden, Inc.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
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M3 - Article
AN - SCOPUS:85051458438
SN - 1930-5044
VL - 11
SP - 770
EP - 802
JO - New York University Journal of Law and Liberty
JF - New York University Journal of Law and Liberty
IS - 2
ER -