What the Legal Challenges on the Future of FDA Regulations Mean: A Two-Part Series

By David Jaworski Senior Advisor, PDA

May 7, 2024

This article is the first of a two-part series to help the industry in understanding the potential reversal of Chevron vs NRDC and its impact on the regulatory landscape.

In a snapshot, potential major impacts include:

·????? Courts may more actively evaluate the scientific basis used to create regulations impacting FDA’s health and safety decisions which could lead to patient harm because poor interpretations of scientific data could be made by judges who do not have the education or knowledge to make such decisions.

·????? The FDA may then be forced to step up legislation requests to reduce ambiguity in the FDCA, Public Health Service Act, and other governing Acts.

An Understanding of Regulatory Development and Deference

Introduction

We’re doing a deep dive on recent developments that may impact FDA Regulations. But first, let’s start at the beginning when regulations were first introduced in the United States. In the late 1800s the railway industry was in growth mode and railroads were being built at a rapid pace, yet there were no national standards. Each railroad company had its own way of operating which prevented standardized, efficient, and safe operations across state lines. To remediate this unworkable situation, Congress passed laws to regulate the railroad industry. Soon, other parts of the government adopted the use of regulations to interpret the laws that Congress passed into workable, standardized solutions.

Regulations are a responsible ongoing practice used by the Food and Drug Administration to enforce its enabling laws. In 1970 the first Title 21 regulations were published to consolidate various regulations related to food and drugs.

Chevron Deference

The current issue at hand is the debate about the foundational 1984 case of Chevron U.S.A., Inc. v. Natural Resources Defense Council (Chevron) affirmed by the Court. This case is now referred to as the Chevrondeference doctrine.[1] The core principle states that when a legislative delegation to an administrative agency on a particular issue or question is not explicit, but rather implicit, a court may not substitute its own interpretation of the statute for a reasonable interpretation made by the administrative agency.

Simply stated, federal courts in general must defer to an agency's reasonable interpretation on points where a statute leaves room for an agency to fill in details or has more than one reasonable interpretation.

Where we are today is there are two cases before the US Supreme Court (Loper Bright Enterprises v. Raimondo) and Relentless Inc. v. U.S. Department of Commerce that challenge the Chevron deference doctrine. Depending on the court’s decision, there may be potential impacts on FDA regulations. The case is focused on the fisheries industry, but it may end up affecting any regulation used by the Executive Branch to enforce the laws that Congress approves and the President signs.?

A Case History

In the1970s, fisheries along the US coastlines were in jeopardy of serious shortages. At the time, many of the fisheries along the Atlantic were being overfished leaving local fishermen without anything to catch and decimating a natural resource. In response, Congress passed the Magnuson-Stevens Fishery Conservation and Management Act of 1976 (MSA) which governed the jurisdiction and management of US fisheries within 200 miles offshore. ?The primarily objective was to prevent foreign fishing companies from overfishing the territorial waters of the US.

Needless to say, fishing companies and local fishermen at the time welcomed the law since they were represented at the regional fishery management councils which still have the authority to establish management plans to prevent overfishing and thereby replenishing fish stocks within the region. These plans were sent to the National Marine Fisheries Service (NMFS), a branch of the National Oceanic and Atmospheric Administration (NOAA) under the Department of Commerce. NMFS is responsible for establishing regulations needed to enforce the management plans and law. [2]

File and Appeal

The current legal challenge intends to retract enforcement of regulations established in 2018. The regulations stipulate that fishing firms pay for onboard federal observers. The observers are responsible for ensuring the “firm” is compliant with the regulations. These particular regulations apply to boats fishing for herring and those using specific fishing methods -- but could have more widespread ramifications.

Loper Bright Enterprises, a collective of commercial Atlantic herring fishing firms headquartered in Southern New Jersey, opposed this regulation since it would increase the cost of operating their commercial fleets. The Loper Bright Case was originally filed with the US district court in 2019 and again in 2021 when it sued Wilbur L. Ross, Jr. the then-head of the Department of Commerce. At the appeals court, Loper Bright went on to challenge the legality of the Chevron deference in its applicability to their case.

As the Loper Bright case worked its way through the appeals process, Relentless Inc., a Rhode Island based herring fishing enterprise that operates a high-capacity freezer trawler, filed a similar case against the US Department of Commerce in 2021. Relentless lost and appealed. Loper Bright then filed their own appeal to the US Supreme Court in November 2022 bringing the Chevron deference back into the picture.

Loper asked the Court to address the following topics:

·???????? Whether the MSA implicitly grants NMFS the power to force domestic vessels (Fishing Firm) to pay the salaries of the federal observers they must carry based upon Chevron.

·???????? Whether the Court should overrule Chevron or clarify that statutory silence does not constitute ambiguity requiring deference to an agency when controversial powers are expressly, but narrowly, granted elsewhere in a statute.

·???????? Determine the proper scope of the MSA and its interpretation.

Relentless filed their next appeal with the US Supreme Court in June 2023 and asked the Court to address the following topics.

·???????? Whether the Court should overrule Chevron or clarify that statutory silence does not constitute ambiguity requiring deference to an agency when controversial powers are expressly, but narrowly, granted elsewhere in a statute.

·???????? Whether the phrase “necessary and appropriate” in the MSA augments agency power to force domestic fishing vessels to contract with and pay the salaries of federal observers they must carry.

Then on October 13, 2023, the US Supreme Court accepted the appeals of both Loper Bright and Relentless and combined both cases into one mutual case. The Supreme Court agreed to hear only one petition: whether the Court should overrule Chevron [U.S.A. Inc. v. NRDC, Inc., 467 U.S. 837 (1984),] or at least clarify that statutory silence concerning controversial powers, expressly but narrowly granted elsewhere in the statute, does not constitute an ambiguity requiring deference to the agency.

Potential Impacts of the Supreme Court Case for FDA Regulation

Let’s go back to the 1984 Chevron case to understand the potential impacts on FDA regulations. The Supreme Court created a legal test for lower courts to determine if a court can grant deference to an agency’s interpretation of a statute that it enforces.

The Chevron two-step test asks:

·????? Has Congress directly spoken to the precise question before the court; and

·????? Is the agency’s interpretation based upon a permissible construction of the statute?

Highlights of the Briefs

?The saga continues to get more complex. Prior to oral arguments at the Supreme Court, there was significant interest in the case. In fact, 86 briefs were filed supporting all parties in both cases. In a wrinkle in time moment, one brief made comparisons to what prompted drafting the Declaration of Independence when New Englanders rebelled against George III because he “erected new Offices and sent hither swarms of Officers to harass them and eat out their substance.” It further asserted, “the respondents have revived cause for similar grievance by promulgating a regulation that requires at-sea monitors to be paid for by the very fishing vessels forced to carry them.”[3]

Read the second article.

[1] Chevron Deference: A Primer, Congressional Research Service (2017) https://crsreports.congress.gov/product/pdf/R/R44954/3

[2] Good general reference article: https://www.fisheries.noaa.gov/leadership-message/governance-fish-forty-years-under-magnuson-stevens-act

[3] Petition for a Writ of Certiorari, RELENTLESS, INC., et al., Petitioners, v. U.S. DEPARTMENT OF COMMERCE, et al., Respondents. https://www.courthousenews.com/wp-content/uploads/2023/10/chevron-part-2.pdf