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Case Detail


In re FDA Delay of “Intended Use” Regulation
On February 5, 2018, WLF filed formal comments with the Food and Drug Administration (FDA), applauding FDA’s proposal to indefinitely delay the effective date of amendments to the existing medical product “intended use” regulations. FDA adopted the amendments in the waning days of the Obama Administration, and they were scheduled to take effect in March 2018. WLF argued that the January 2017 regulations should never be permitted to take effect, and should eventually be repealed, because their adoption was both procedurally and substantively defective. In particular, WLF argued, the regulations would criminalize truthful manufacturer speech about off-label uses of FDA-approved medical products, in violation of the First Amendment rights of both manufacturers and the recipients of their speech.
Case Status:
Awaiting decision.
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