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Case Detail


Report on FDA First Amendment Abuses
(Regulatory Proceeding)
On August 7, 2006, WLF issue a comprehensive report that concludes that FDA regulation of prescription drug promotion is being conducted in a manner that routinely violates both the First Amendment and FDA's statutory mandate. The report is based on WLF's study of all regulatory compliance letters sent by FDA within the past year to pharmaceutical manufacturers. The report concludes that FDA routinely orders suppression of truthful speech, demands that manufacturers engage in "corrective advertising" in the absence of any evidence that consumers have been misled by supposedly misleading advertising, and violates federal administrative law by using compliance letters (rather than established notice-and-comment procedures) to adopt new agency policies regarding product promotion. WLF has submitted its report to FDA in the form of a Citizen Petition, requesting that FDA take corrective action.
Case Status:
Awaiting FDA response.
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