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Articles 1 - 3 of 3
Full-Text Articles in Law
Drug User Fees, Health Priorities, Politics, The Deficit And Reform Directions, Margaret Gilhooley
Drug User Fees, Health Priorities, Politics, The Deficit And Reform Directions, Margaret Gilhooley
Margaret Gilhooley
The Food and Drug Administration now depends on user fees paid by drug companies to support more than half the salaries of the medical reviewers who advise the agency on the appropriateness of approving the drug. The funding creates a substantial risk of "capture" of the agency by the industry. Under the program,which started in 1992, drug companies pay a fee that permits the agency to hire additional reviewers to make more timely reviews on whether a drug can be approved. Under the law the agency seeks to meet performance goals for the timing of reviews, giving the program the …
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 …