Industry Groups: FDA’s ‘Intended Use’ Proposal Violates First Amendment

By Beth Wang / January 4, 2021 at 3:03 PM
The drug and device industries are pushing back against FDA’s plans to finalize a rule this month that will amend the definition of “intended use,” alleging the rule would violate the First and Fifth Amendments. The arguments are highly similar to those posed by the regulated industries in 2017, when the agency last tried to amend the definition before being brought to a standstill amid pushback from Congress and stakeholders. FDA’s 2017 proposal said the agency would factor “the totality...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.