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Case Detail


In re: FDA Amendments to “Intended Uses” Regulation
On May 19, 2017, WLF filed formal comments with the Food and Drug Administration (FDA), calling on FDA to rescind a January 2017 regulation that expanded the circumstances under which the agency may sanction a drug or medical device manufacturer for allegedly improper promotion of its products for off-label uses. WLF argued that adoption of the new regulation was both procedurally and substantively defective. WLF asserted that the new regulation is invalid because FDA made substantial, last-minute changes to its regulation, thereby denying interested parties a meaningful opportunity to provide comments on the version of the regulation that FDA approved. WLF also argued that the new regulation exceeds FDA’s statutory authority and violates the First Amendment rights of manufacturers to speak truthfully about their products. In March 2017, FDA delayed the effective date of the new regulation until 2018 and requested comments on whether it should rescind the regulation.
Case Status:
Awaiting FDA Response.
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