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What Will FDA Do If Supreme Court Curtails Chevron Deference?

 
• By Brenda Sandburg

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.

FDA lawsuit
Supreme Court case could curtail FDA advantage in litigation • Source: Shutterstock

The US Food and Drug Administrative may have a harder time winning lawsuits challenging its interpretation of statutes it administers if the US 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 you could expect that “the agency’s administrative record is going to be much, much more robust in terms of justifying its positions,” Freddy Jimenez, senior vice president and general counsel of Celldex Therapeutics, Inc

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