FDA Policy/General

FDA Watching SCOTUS Auer Case

FDA, along with many other federal agencies, is watching how the Supreme Court handles a case testing the long-standing notion that courts should defer to federal agencies in the agencies’ interpretation of their own regulations. Although the case before the high court involves veterans’ benefits, observers say the decision will have broader impacts on other agency litigation.

An E&E News online report says the question the court will debate is whether it should drop Auer deference, “the standard that directs judges to defer to an agency’s reasonable interpretation of its own ambiguous regulation.” The standard is named for a 1997 precedent.

Auer has long been a target for political conservatives, the report says, who claim that it helps fuel an unwieldy administrative state that acts more like a legislative body and isn’t accountable to voters.

Typical of the comments quoted in the article, the National Federation of Independent Business Small Business Legal Center’s Karen Hamed said during a Federalist Society call that under Auer agencies “get to write the law and then they get to interpret it.” As a result, she said, agencies can easily change their interpretations of regulations and create uncertainty for companies that have to follow the rules.

E&E News reports that the court received “dozens” of amicus briefs calling for an overhaul of the Auer standard, compared with just two briefs asking that it remain in force.

Although the article does not mention FDA specifically, the agency often receives deference from the courts and would clearly be affected if Auer is changed.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome