What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?

Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.

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The US Food and Drug Administrative may have more difficulty winning lawsuits challenging its interpretation of statutes it administers if the Supreme Court eliminates the Chevron deference it has been afforded for nearly 40 years. And the agency will have to be more assiduous in laying the foundation for such legal battles, lawyers say.

If the Supreme Court upsets this doctrine, says Freddy Jimenez, Celldex Therapeutics, Inc., senior vice president and general counsel,...

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