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Key Regulatory issues to monitor for clinical trials in 2024 and beyond

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Blog

DATE
January 31, 2024

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The regulatory landscape surrounding clinical trial data is undergoing continual expansion and complexity, necessitating vigilant attention from clinical researchers as they navigate evolving regulations. Influential policy recommendations and guidance documents are starting to surface against this dynamic backdrop in important countries like the US, the EU, Canada, and beyond. These projects have the potential to significantly impact how clinical trials gather data in the coming year and beyond.

The pharmaceutical industry in 2024 is shaped by notable legal and regulatory developments that transpired in 2023. The Supreme Court, in a pivotal move, addressed the standard for enablement in the context of antibody genus claims and refrained from overturning Federal Circuit decisions related to written description and induced infringement concerning skinny labels. Simultaneously, the current administration unveiled new regulatory objectives impacting the pharmaceutical sector. These include announcements regarding the integration of artificial intelligence (AI) in drug development, coupled with joint efforts from the White House and the Federal Trade Commission to curtail prescription drug costs. This involves challenging the propriety of patents listed in the FDA Orange Book and leveraging “march-in” rights under the Bayh-Dole Act.

AI Integration and Regulatory Objectives

In response to these developments, the FDA introduced initiatives on artificial intelligence and machine learning in drug development. The agency issued discussion papers as part of its communication strategy with stakeholders, aiming to explore considerations for the use of AI/ML in developing drugs and biologic products. While lacking specific policy proposals, these papers underscore the FDA’s acknowledgment of the pivotal role AI/ML will play in drug development. Furthermore, the FDA expressed its commitment to adopting a flexible risk-based regulatory framework that fosters innovation with AI while ensuring patient safety.

Executive Order on AI and Intellectual Property

President Biden’s executive order on artificial intelligence in October 2023 outlined broad initiatives aimed at enhancing safety and security in the rapidly evolving AI space. This includes directives to the US Patent and Trademark Office (USPTO) director to provide guidance on inventorship in AI use and address other considerations at the intersection of AI and intellectual property within specified timeframes. Consequently, the industry anticipates requested guidance in February and July, providing stakeholders with an opportunity to review and comment, actively contributing to the shaping of USPTO regulations involving AI.

Federal Initiatives on Drug Costs

In parallel, federal agencies focused on reducing drug costs in 2023. The Federal Trade Commission, in September, announced objectives to combat improper Orange Book listings, which it views as barriers to generic drug manufacturers entering the pharmaceutical market. Subsequently, the FTC challenged over 100 patents through an FDA regulatory process in November 2023, alleging improper listing in the Orange Book. Responding to this, Senator Elizabeth Warren and Representative Pramila Jayapal urged targeted companies to address the allegations and voluntarily delist challenged Orange Book patents. As the industry awaits outcomes, the FTC is contemplating next steps for companies ignoring warning letters.

Policy Objectives and the Bayh-Dole Act

December 2023 brought new policy objectives from the Biden Administration, aiming to reduce prescription drug prices, partly through the utilization of the Bayh-Dole Act. This legislation allows certain entities to retain title and commercialize patents resulting from federally funded research, subject to specific criteria. Simultaneously, the National Institute of Standards and Technology (NIST) released a draft inter-agency framework for “march-in” rights, allowing agencies to consider price and terms in determining whether to license patents from federally funded research.

Conclusion

Judicial interpretations of the conditions for patentability in 2023 influenced the composition of pharmaceutical patent claims. Moreover, many governmental and regulatory initiatives focused on AI advancements and attempted to lower prescription costs. It is recommended that interested parties keep an eye on proposed rules in both areas and communicate with relevant authorities to actively influence laws that affect the pharmaceutical sector.

The U.S. FDA revised its position on the use of electronic systems, records, and signatures in clinical studies in 2023 and released guidelines for the planning and execution of Decentralized Clinical Trials (DCTs). In addition to developing guidelines, the FDA set up a broad framework that included internal mechanisms for evaluating decentralized and virtual trials, workshops, demonstration projects, stakeholder participation, and a dedicated website.

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