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The Short- and Long-Term Impact of Chevron’s Rejection on the FDA
(Thursday, July 18, 2024) A couple of weeks back I speculated if we need an independent oversight of the FDA to rein in the seemingly unaccountable power its leadership holds over the industry it regulates. The same week, the US Supreme Court reversed a decades-old legal doctrine that gave government agencies, like the FDA, such power. There are divergent opinions on what it could mean for the industry. Nevertheless, this ruling will have far-reaching impacts on how the FDA works, not all of it are negative. The “Chevron Doctrine” was created by another Supreme Court ruling from 1984 which asked the courts to defer to a government agency’s interpretation of a law it administers when Congress has not directly addressed a question about the law at the center of a dispute. The fact that the courts could not use an independent interpretation of the law, meant that it was almost impossible to challenge an Agency’s interpretations of the laws it administers. The Chevron Doctrine was cited in more than 18000 count decisions in the 40 years since its creation. Although, the original Doctrine stated that “a court was required to uphold the agency’s interpretation of the statute as long as it was reasonable”, the courts almost always decided in favor of the Agency being sued, not wanting to go against the conventional practice. And that’s where the concern resides. In a democratic system, giving any agency an unquestionable power could lead to unintended consequences. Let’s look at the FDA’s use of this Doctrine to interpret laws. The FDA has relied on the Chevron Doctrine for several controversial decisions. Regulation of Lab Developed Tests, approval of new products with questionable supporting evidence, and the regulation of autologous stem cell therapies are a few such examples. These decisions are based on the FDA’s interpretation of ambiguous laws. All of these decisions have been challenged in courts but so far the challengers had little hope of a favorable decision. That could change now that the courts can seek independent opinions and make their own assessment of the law. This would require the FDA to present a justification of the reasonableness of its decisions, something it did not have to do so far. The current Supreme Court decision allows the courts to consider the FDA’s interpretation and other evidence in making its ruling. Since it would strengthen the hands of challengers of the FDA in courts, the primary concern expressed by many is the uncertainty it will introduce in the industry. The loss of status quo is never applauded by an industry that has spent years learning the processes. This is a valid concern. However, being able to question the FDA’s decisions at the courts could provide a truly independent venue for stakeholders perplexed by questionable decisions. FDA will not change automatically due to this reversal of the Chevron Doctrine. The court processes are slow and expensive, hence most companies will prefer to resolve issues with the FDA. Only the most controversial decisions pursued by the most motivated and well-funded stakeholders will be likely challenged. So, for most of us this decision, although a regulatory landmark will have limited impact. For those looking to challenge the FDA, this is the silver lining they were looking for. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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