Introduction
In the complex landscape of governance, federal agencies wield significant authority in executing and enforcing laws enacted by Congress. These agencies, however, are subject to oversight through administrative law, which provides a structured framework for individuals and entities to contest agency decisions. This article aims to explain some foundational principles of challenging federal agency decisions, including specific examples and references to relevant statutes.
Understanding Administrative Agencies
Administrative agencies, established by legislative mandate, are entrusted with implementing and enforcing the specific laws implemented by Congress. Federal agencies are creatures of statute, and such Congress (if it does so) may limit the authority of the agency. Once so established, typically, these agencies can possess quasi-legislative, executive, and judicial powers, enabling them to promulgate regulations, enforce compliance, and adjudicate disputes within their jurisdictional bounds. Notable examples include the Food and Drug Administration (FDA), responsible for regulating food and drug safety, and the Environmental Protection Agency (EPA), tasked with environmental protection and regulation.
Types of Agency Actions
Federal agencies engage in various actions, including rule-making, adjudication, and issuing orders and licenses. Generally, there are three sources of authority for agency rule-making. First, Congress can expressly confer rule-making to the agency, with the force of law, as outlined in the Administrative Procedure Act (APA), [5 U.S.C. Section 553]. Second, rule-making come from agency discretionary activities such promulgating internal procedural requirements, or through adjudication. Adjudication encompasses the resolution of disputes through administrative proceedings, governed by procedural rules established by each agency. Third, agencies issue orders, licenses, permits, and other administrative decisions that significantly impact individuals and businesses. And tied with the third prong is judicial review in the courts.
Grounds for Challenging Agency Decisions
Pharmaceutical companies are often at the receiving end of FDA decisions. There is an implicit perception in the industry that one “shall not challenge the FDA in court” because the aggrieved company fears losing a good working relationship with FDA personnel and a further fear that if FDA is called out on its actions or challenged in court, FDA will be punitive in future interactions. Pharma companies can challenge agency actions on several grounds, including:
1. Procedural Errors: Agencies must adhere to procedural requirements specified by law, as mandated by the APA, [5 U.S.C. Section 706(2)(D)]. Procedural errors may include failure to provide notice and an opportunity to be heard, arbitrary decision-making, or a lack of substantial evidence. For example, if FDA intends to withdraw approval of an approved drug, the law requires due notice and opportunity. And fights may occur regarding the sufficiency of the notice and process. See, John D. Copanos and Sons, Inc. v. Food and Drug Admin., 854 F.2d 510 (DC Cir. 1988).
2. Substantive Errors: Agency actions must comply with governing statutes and avoid arbitrariness, as outlined in the APA,[5 U.S.C. Section 706(2)(A)]. Substantive errors may occur when agencies exceed their statutory authority, misconstrue the law, or act unreasonably. Genus Medical Technologies LLC v. United States Food and Drug Administration, 994 F.3d 631 (DC Cir. 2021)(FDA’s interpretation that a product was a drug, not a device, was wrong. It was a device.). And whether the agency activity is within the bounds of the implementing statute is a function of whether the implementing statute is clear or ambiguous. If the statute is ambiguous then the question arises of whether the agency’s activity is given deference under the typical Chevron standard. The Supreme Court is set to issue a decision in the 2024 Loper case on the scope of Chevron deference, if any, to be afforded.
3. Constitutional Violations: Agency actions that infringe upon constitutional rights are subject to judicial review, as guaranteed by the U.S. Constitution. In Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the Supreme Court struck down an FDA regulation restricting the promotion of compounded drugs on First Amendment grounds.
4. Ultra Vires Acts: Agencies must operate within their delegated authority, as defined by statute and judicial precedent. Actions beyond this authority are considered ultra vires and may be challenged in court. For instance, in Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), the FDA could not regulate tobacco as a drug product.
5. Abuse of Discretion: Courts may review agency decisions for abuse of discretion, as per the APA, [5 U.S.C. Section 706(2)(A)]. An abuse of discretion may occur when agencies act irrationally, arbitrarily, or contrary to the evidence. See e.g., Teva Pharmaceuticals v. FDA, 514 F.Supp.3d 66 (DC DC (2020)(FDA did not act arbitrarily in classifying protein drug as a “drug”); but see Purepac Pharmaceutical v. Thompson, 354 F.3d 877 (DC Cir. 2004)(FDA acted arbitrarily in requiring ANDA filer to file Para. IV certification).
Administrative Remedies and Exhaustion
Before seeking judicial review, litigants typically must exhaust administrative remedies, as required by the APA [5 U.S.C. Section 704]. This entails pursuing all available avenues of relief within the agency, such as filing appeals or petitions for reconsideration. Exhaustion ensures that administrative agencies have the opportunity to correct errors and develop a factual record before judicial review. See, e.g., Association of American Physicians v. FDA, 358 Fed.Appx. 179 (DC Cir. 2009)(not fully exhausted because plaintiffs failed to file citizen petition). And whether the company has exhausted its options includes the question of whether there is final agency action. A Complete Response Letter (CRL) is not final agency action. Nostrum Pharmaceuticals, LLC v. FDA, 35 F.4th 820 (DC Cir. 2022)(we represented Nostrum to challenge the FDA’s CRL as being final agency action).
Should I Challenge the FDA?
There is the misperception that one is not allowed to challenge the FDA. Pharma companies can challenge the FDA in myriad circumstances. FDA makes decisions on the work needed to get a drug approved; whether to approve the drug based on existing evidence or require even more work; withdrawing approved drugs; classifying drugs and determining if approved drug products warrant any data or market exclusivity; etc. A resounding YES that one can challenge the FDA. FDA is also not a punitive agency that will “hold it against” the company for the challenge. Indeed a challenge may be the only way FDA will act in accordance with law.
Conclusion
Administrative law serves as a vital mechanism for holding federal agencies accountable and safeguarding individual rights. By understanding the basics of challenging agency decisions and the relevant statutes, individuals and entities can effectively assert their interests. As guardians of the rule of law, the judiciary plays a crucial role in ensuring that administrative actions align with legal principles and statutory mandates, including within highly specialized agencies like the FDA.
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