Implications of Loper Bright for FDA-Regulated Products

5 min

Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own reactions.

When our own Jeremiah Kelly and Laura Rich, who collectively have spent over 20 years at the Food and Drug Administration (FDA), including stops at the Office of Chief Counsel, CDER, CBER, and CFSAN, tell stories of their time at the agency, they always talk about how FDA works long and hard to "get it right." Now, without the backstop of Chevron deference to an agency's interpretation of law, the staff may have to work harder to ensure that its administrative record is adequate. This may be the practical legacy of Loper. It is not necessarily that the majority does not trust an agency's experience and judgment; it is that now agencies are going to have to ensure that they have taken the time to adequately explain why their reading of a statute is the "best," which is not necessarily a bad thing.

A recent study of federal appellate court decisions since 2000 found that FDA prevailed in every appellate opinion that applied the two-step Chevron analysis to cases concerning statutory authority claimed by FDA. See Liam Bendicksen, Aaron S. Kesselheim, and C. Joseph Ross Daval, FDA and Chevron Deference: A Case Review. More specifically, in the ten cases in which courts found the relevant statutes to be ambiguous, the court decided in FDA's favor after finding its interpretation reasonable. Id. This makes sense. FDA has historically commanded great respect, and even before Chevron, courts deferred to its expertise. Id. At 372. Now, however, increased litigation against FDA is more likely, and litigants may have a better shot at success.

As we move forward in a post-Chevron world, below are additional thoughts from Venable's FDA Group:

  • FDA's interpretations still matter, but there is greater uncertainty. As stated in the opinion, "An agency's interpretation of a statute 'cannot bind a court,' but may be especially informative 'to the extent it rests on factual premises within [the agency's] expertise.'" Nonetheless, Loper increases the risk that regulated entities may be more willing to turn to the courts when they disagree with FDA's analysis. This in turn may make it difficult for industry to rely on agency interpretation.
  • The real-world impact of Loper remains unclear, but FDA will continue to feel the heat in certain "hot spots." It is unclear how Loper will play out when it comes to important questions concerning FDA's statutory authority under, and interpretation of, the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act. In our view, medical product jurisdictional issues (e.g., combination products, device versus drug determinations, etc.), laboratory developed tests, market exclusivity under the Hatch-Waxman Act or the Biologics Price Competition and Innovation Act frameworks, interchangeable biosimilars, and novel drug or biologics approvals in the orphan drug or cell and gene therapy space could see increased scrutiny post-Loper. Depending on the facts, new challenges to FDA determinations may have increased chances of success. It will be important to actively monitor and evaluate FDA's and competitors' activities and to consider whether they present an opportunity or risk.

    That said, as a practical matter, we also believe Loper will have a minimal impact on matters that fall under the purview of CFSAN and perhaps will also have a minimal impact on those matters that fall under the purview of CVM. Medical foods, new dietary ingredient notifications, and the scope of structure/function claims for foods and dietary supplements may be areas where litigation could develop if the agency takes a restrictive view.

    By way of example, FDA's guidance documents on medical foods and structure/function claims for foods are ripe for review under Loper if FDA continues to read into the statute language that simply does not exist. Indeed, FDA will have a hard time pointing to anything in the Orphan Drug Act that limits medical foods to products intended for patients who have a "limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs." It will also be difficult for FDA to assert that under the FDCA, structure/function claims for foods must be based on the nutritive value of the food when the language of the Act on its face simply does not require it. In the past, it is possible a court may have given deference to the FDA's interpretations of the relevant statute, but under Loper. FDA's interpretation will likely not survive a challenge if FDA attempts to pursue enforcement action against a company marketing one of these products.

  • Decelerating FDA rulemaking. Consider submitting substantive comments when FDA is engaged in rulemaking. If you agree that an intended interpretation of a statute is the "best," you may wish to submit a substantive comment letter supporting it, because doing so may facilitate the agency's ability to build a strong record to support its position. Similarly, if you do not believe FDA has chosen the best possible interpretation when others were available, the agency may now be more open to revisiting its position. One thing seems clear: the rulemaking process will slow down even more. Furthermore, challenging rules already in place where FDA has recognized that it has chosen one permissible statutory interpretation out of several may become easier.
  • Accelerating reliance on FDA guidance. FDA issues more guidance documents—which lack the force and effect of law—than most federal agencies. This is with good reason—the rapidly evolving scientific and technological issues at stake necessitate nimbleness. Post-Loper, we will likely see the agency increasingly rely on FDA guidance documents to explain its interpretation of, or policy on, a regulatory issue. As with rulemaking, this is the time to consider substantive engagement in FDA's guidance development. Now more than ever, robust participation can help shape the regulatory terrain for your company's mission success.

Venable's FDA Group stands ready to help you navigate this evolving landscape with expertise that spans the full spectrum of products that FDA regulates. We look forward to helping your company optimize regulatory outcomes in a post-Chevron world. If you have questions, please contact Todd Harrison, Claudia Lewis, Justin Coen, Jeremiah Kelly, or Laura Rich.