News Brief: Navigating Regulatory Uncertainty

“This is going to be a really interesting and critical next few years as the courts start to re-interpret some of the fundamentals that we have grown to rely on in the food and drug industry in terms of how the industry is regulated and, more broadly, all of the regulatory agencies out there,” said Thomas Cosgrove, Partner at the law offices of Covington & Burling LLP and former Acting Director of U.S. FDA Center for Drug Evaluation and Research’s Office of Compliance.

On September 8th, the PDA Capital Region Chapter hosted, "The Chevron Doctrine Decision and Its Impact Roundtable”, discussion concerning the reversal of the Chevron case that garnered a half-packed room. Thomas took the podium to address everyone in attendance about the case and its impact on the industry and how we — the industry — can move forward. 

Thomas pointed out that the best way to push forward as an industry after the reversal of Chevron would be to “break things down into fundamentals” by figuring out what the rules are, how to anticipate what the rules might be and how they change and how to make sure that not only the products that companies are making are safe for patients but also compliant with regulatory expectations.

Thomas exclaimed that starting from fundamentals are important because the courts are no longer deferring to the regulatory agencies on what the law is — judges will now be deciding what the law is, which can potentially create an era of uncertainty when trying to figure out what it means for a drug to be safe, effective and GMP compliant.

Though Thomas ultimately believes that the courts will make the right decision regarding future rulings, he also believes that in order for the industry to better prepare itself for the future, it would be to continue asking the questions of how certain laws will change and, in what direction.