Co-Author(s):
J. Kaitlin Morrison, PhD
Executive Director Clinical Research, UNC Lineberger Comprehensive Cancer Center
Assistant Professor of Medicine- Hematology, University of North Carolina- Chapel Hill
Aisha Khan, PhD, MBA
Executive Director, Clinical Research Cellular Manufacturing Program
Interdisciplinary Stem Cell, University of Miami Miller School of Medicine
New U.S. administrations often usher in changes as their directions, visions, and strategic goals vary based on the priorities of the political party in power. These shifts can influence a wide range of policies, from economic initiatives to healthcare reforms and environmental strategies. During such transitions, questions frequently arise about the stability and predictability of regulations that govern industries, businesses, and societal operations.
This uncertainty often sparks a critical question: Will the "rules of the road" that provide guidance and structure remain constant, or will they be subject to significant changes? Regulations play a vital role in ensuring consistency, safety, and fairness across various sectors, but they are also tools for addressing new challenges, priorities, and advancements.
Understanding what regulations are and how they function is essential. Regulations are formal rules established by government agencies to implement and enforce laws passed by Congress. They are crafted to provide clear guidelines for compliance, but their creation and modification involve complex processes. Changing regulations typically requires public input, extensive review, and alignment with overarching legal frameworks. However, certain changes can occur more swiftly under executive orders or other administrative directives, leading to debates about how easily or quickly these "rules" can shift with changing administrations.
This dynamic nature of regulations raises concerns about predictability and stability for businesses and individuals alike. Therefore, it is crucial to understand the mechanisms behind regulatory change and the implications such changes may have for different sectors.
What are regulations?
Regulations have the same force and effect as laws. They are how executive branch Agencies such as the FDA enact laws passed by Congress.
Laws provide a framework, and regulations fill in operational details, such as how the law will be implemented and enforced. For example, the Public Health Service Act was enacted in 1944, giving FDA authority over biologics. The act included provisions for the licensing of new biological products through an application process. Regulators at the FDA then developed the process for carrying out the approval of new biological products (as required by the act) and authored 21 CFR Parts 600-680, defining this process. Thus, the FDA had a defined regulation outlining an application process for the approval of new biological products, and this regulation, once finalized, had the power and force of the law it carried out.
How are regulations made?
Regulations are created through a process referred to as “rulemaking” before they become enforceable.
Drafting of the Regulation
The Unified Agenda publishes a list of planned rulemaking activities within the next six months semi-annually. Rulemaking starts with career FDA staff writing and/or revising regulations as directed by laws approved by Congress or applicable court cases.
Review by the Office of Management and Business (OMB)
Once a regulation is drafted, it is typically reviewed by the OMB, which ensures that the President’s vision is upheld and the regulation does not conflict with other Agencies. Additionally, OMB evaluates the economic and regulatory impact of the proposed rule.
Public Comment
Rulemaking is governed by the Administrative Procedure Act of 1946 (APA, 60 Stat. 237), which gives the public the right to participate in the process. New regulations and/or changes in regulations are announced as proposals in the Federal Register. The public can then submit comments for at least 60 days for the FDA to consider prior to the rule's finalization.
Analysis of the Public Comments & Finalization of the Rule
The public comments are then analyzed, and revisions are made as deemed appropriate by the FDA. Of note, not all public comments need to be addressed or incorporated into the final rule. The rule is finalized, and notification is published in the federal register 30 days before it goes into effect. The regulation is released within the Code of Federal Regulations and has the force of law.
Are Regulations Easily Changed by a New Administration?
Regulations are not easily changed with a new administration. Unlike policies that can be altered through executive orders, regulations carry the force and power of law, making them more robust and resistant to political shifts. Changing or repealing regulations requires adherence to formal processes, ensuring regulatory stability.
An agency must follow the rulemaking process outlined in the Administrative Procedure Act (APA) to revise or remove a regulation. This process includes public input, economic analysis, and thorough review to ensure the revised regulation remains consistent with the law approved by Congress. Both the original and revised versions are recorded in the Federal Register, which opens the door to legal challenges based on differing interpretations of the congressional law that authorized the regulation. Regulations must always align with congressional intent and cannot be arbitrarily altered.
However, there is a streamlined path for rolling back recently issued regulations. Congress has 60 legislative days after a regulation is published to vote to disapprove it. If this period extends into a new Congress's term, the clock restarts, allowing the incoming Congress to review the regulation. Regulations published after late May in an election year are particularly vulnerable to disapproval under this mechanism. Even then, the process requires congressional action, presidential approval, or a veto override, underscoring the deliberate nature of regulatory change.
Another way to change regulations is through new or revised legislation. This requires Congress to pass a law signed by the President. Once the law is enacted, agencies must follow the rulemaking process to implement the new regulation. This time-consuming and intricate process ensures that regulations remain grounded in legal authority and subject to public and expert scrutiny.
Court cases also influence the evolution of regulations. New administrations, through the Justice Department, may choose how rigorously to defend the previous administration’s regulations in court. These legal challenges can determine whether a regulation remains in effect, is modified, or is repealed.
By design, the regulatory system prioritizes consistency and adherence to the law, minimizing the potential for abrupt or politically motivated changes. This deliberate process ensures that regulations serve the public interest and adhere to congressional intent rather than being swayed by the priorities of a single administration.
The Reach of Executive Orders in Regulatory Change
Executive orders, while powerful tools for directing federal agencies, have limitations in their reach and scope when it comes to altering existing regulations. Unlike regulations, which carry the force of law under the APA, executive orders cannot override laws passed by Congress or regulations already in effect. Instead, they primarily serve to:
- Direct Agency Priorities: Executive orders can influence how federal agencies prioritize enforcement of existing regulations or allocate resources to specific initiatives. For example, a new administration may issue an order focusing regulatory attention on specific public health concerns or environmental protections.
- Suspend or Delay Implementation: In some cases, executive orders can delay the implementation of recently finalized regulations pending further review. However, these delays are temporary and require the formal rulemaking process for permanent changes.
- Set Policy Agendas: Executive orders often establish new priorities or frameworks for future regulatory actions, signaling the administration's vision without directly changing existing rules.
While executive orders can initiate shifts in how regulations are enforced or interpreted, substantive changes to the regulations themselves must still go through the formal rulemaking process. This ensures that regulatory modifications remain consistent with statutory authority, subject to public input, and compliant with legal standards.
By maintaining this structured and deliberate process, the regulatory framework ensures stability and adherence to the law, even during periods of political change. Understanding the interplay between executive orders and the regulatory process helps clarify their respective roles and limits, fostering trust in the system’s ability to balance flexibility with the rule of law.
What is the Chevron Doctrine, and what does it overturn mean?
The Chevron Doctrine originates from a 1984 Supreme Court decision, which granted federal agencies significant deference in interpreting ambiguous laws passed by Congress when designing regulations. Under this doctrine, as long as an agency's interpretation of a law was reasonable, courts were expected to defer to the agency's expertise during litigation.
An overturn of the Chevron Doctrine shifts this dynamic, granting courts the authority to interpret laws passed by Congress rather than relying on federal agencies' interpretations. This change increases the likelihood of litigation against agencies like the FDA, potentially leading to more regulations being challenged, revised, or overturned through court rulings.
Conclusion:
While regulations can be revised or disapproved, the process to adjust or remove them remains lengthy and complex, reflecting their legal weight. This system provides stability and consistency across administrations, even during times of political transition. It is precisely this structured and deliberate process—requiring input and approval from Congress, the President, and the public—that sets the United States apart from other nations. This transparency and rigor inspire trust in the regulatory framework, ensuring it remains a dependable backbone for governance and public confidence.
References
- U.S. Government Publishing Office. (n.d.). Administrative Procedure Act (5 U.S.C. Subchapter II). Retrieved from https://www.govinfo.gov/
- U.S. Government Publishing Office. (n.d.). Administrative Procedure Act, 5 U.S.C. § 551. Retrieved from https://www.govinfo.gov/
- U.S. Government Publishing Office. (n.d.). Administrative Procedure Act, 5 U.S.C. § 552. Retrieved from https://www.govinfo.gov/
- U.S. Government Publishing Office. (n.d.). Administrative Procedure Act, 5 U.S.C. § 553. Retrieved from https://www.govinfo.gov/
- Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).
- Schonfeld, Z. (2023, May 4). Chevron case: Supreme Court could take a sledgehammer to agency power. The Hill. Retrieved from https://thehill.com/regulation/court-battles/3986610-chevron-case-supreme-court-could-take-sledgehammer-to-agency-power/
- Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842 (1984).
- National Association of Pharmaceutical Manufacturers v. FDA, 637 F.2d 877, 887 (2d Cir. 1981); see also 21 U.S.C. § 371(a).
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