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Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley
Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley
Margaret Gilhooley
1/11/10
PREPUBLICATION VERSION
DRUG SAFETY AND COMMERCIAL SPEECH:
TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES
By Margaret Gilhooley©
ABSTRACT
This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …
Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley
Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley
Margaret Gilhooley
1/11/10
PREPUBLICATION VERSION
DRUG SAFETY AND COMMERCIAL SPEECH:
TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES
By Margaret Gilhooley©
ABSTRACT
This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …