The US Food and Drug Administration, like every federal agency, is entering a new era of uncertainty about the scope of its regulatory authority.
Key Takeaways
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The five-year user fee reauthorization schedule allows Congress a vehicle for dealing with legal decisions impacting its authority, like the uncertainty following the Supreme Court’s overrule of the Chevron doctrine.
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Sen. Bill Cassidy acknowledged the review system will be helpful, but said the FDA must abide by Congress’ decisions
The US Supreme Court’s 28 June decision overturning the so-called “Chevron Doctrine,” which guided judicial review of agency actions for decades, opens up new avenues to challenge FDA policies and practices. At a minimum, the agency can expect more litigation in the coming years and the very real prospect that seemingly settled regulatory precedents may be suddenly unsettled
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