Former FDA attorneys say the Supreme Court's recent decision to overturn Chevron deference, a decades-old legal precedent, could stall the development of new drugs and medical devices, Politico reported July 1.
On June 28, the Supreme Court voted 6-3 to repeal the doctrine that has been in place since 1984. The Chevron deference stipulated that when disputes arise over vague or ambiguous laws, judges should defer to federal agencies like CMS and the FDA for interpretations, so long as the interpretation is reasonable. The overturning essentially removes the automatic deference previously given to federal agencies, meaning courts will interpret statutes themselves when disputes arise.
Under the ruling, the FDA's decision-making process may come under greater scrutiny, former officials told the news outlet. It could also affect medical device manufacturing.
"The agency is really going to have to build in a lot more explanation of why it comes to the decisions that it does," Jerry Masoudi, a partner at Covington and Burling and former FDA chief counsel, told Politico.
The Supreme Court's decision is expected to especially affect federal agencies whose policies are guided by science, such as the FDA, former officials at the agency told the news outlet. For example, agencies may be challenged with lawsuits more often as scientific evidence evolves.
The ruling has the potential to affect health policy on numerous fronts, including bringing forth more legal challenges to Medicare payment rates. It also paves the way for challenges over what preventive services are covered under the Affordable Care Act, and additional suits over whether the Emergency Medical Treatment and Labor Act preempts state law where abortion is prohibited and does not make exceptions for the health or life of a pregnant person, Politico reported.