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2025-01-23| LicensingPolicy

Drug Promotion, Nonprescription Pathways, and Advanced Manufacturing: FDA’s Key Focus Areas in 2024 and What’s Next for 2025

by Bernice Lottering
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FDA on drug development and regulation, with a focus on misinformation, nonprescription drugs, and advanced manufacturing technologies. Image: Getty Images

Each new year brings its own challenges, from navigating fresh innovations to revisiting familiar issues in new forms. As 2025 begins, reflections on the FDA’s 2024 activities in drug development include key areas such as administrative changes, clinical trial design and expedited programs. While the Trump administration may shape these outcomes, the extent of its influence remains uncertain.

Most recently, executive orders have directed federal health agencies, including the FDA, CDC, and NIH, to pause external communications, such as scientific reports and health advisories. Amid these directives, the focus shifts to the FDA’s expected outlooks, emphasizing developments independent of presidential influence for now.

An Ongoing Push for Progress in Drug Development

The FDA continued its regulatory activities in 2024, even amid the transition to new leadership. While many tasks like reviewing applications and enforcing regulations proceeded as usual, certain activities, such as the publication of new regulations and guidance documents, slowed down temporarily. For example, the new guidance on addressing misinformation about medical devices and prescription drugs, published in 2024, reflects growing concerns over how medical products are communicated.

However, the agency made significant progress in drug promotion and regulation throughout 2024, setting the stage for key developments in 2025. It finalized guidance on “Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products,” first released as a draft in 2023. While the guidance clarified some areas, it left the enforcement zone for certain unapproved uses undefined. Future enforcement actions may reveal the scope of this zone and its practical implications.

Guidance on Unapproved Uses, Nonprescription Drugs, and Advanced Manufacturing Initiatives

The FDA also finalized its guidance on the communications from firms to healthcare providers regarding unapproved uses of approved medical products. This guidance clarifies the FDA’s stance on when it will enforce rules related to unapproved uses. However, the exact scope of the enforcement “zone” remains unclear, and future enforcement actions will likely provide more clarity.

In the nonprescription drug space, the FDA finalized a regulation that establishes a pathway for approving nonprescription drugs with additional safety measures, known as Additional Conditions for Nonprescription Use (ACNUs). This rule could open the market for nonprescription drugs with added safety precautions, though full industry and FDA implementation is still unfolding.

Additionally, the FDA finalized guidance for its Advanced Manufacturing Technologies Designation Program, which supports novel manufacturing processes.  Another guidance on the platform technology designation program allows sponsors to request the designation of certain technologies as platforms for future drug applications. These initiatives aim to streamline drug manufacturing processes. Both programs show the agency’s drive to incentivizing advanced manufacturing and technology adoption. These initiatives highlight a continued focus on innovation in drug development and regulation, a trend likely to persist in the coming years.

Balancing Traditional Practices with Emerging Methodologies: FDA’s 2024 Guidance on Drug Development

Then, the organization adopted Annex 2 to ICH E6(R3) on Good Clinical Practice, addressing decentralized and real-world data trials. Following, the FDA issued a draft guidance on Diversity Action Plans to increase underrepresented population participation, ensuring stronger and more generalizable evidence. The agency also emphasized the importance of race and ethnicity data to assess population-specific drug responses.

FDA’s oncology-specific guidance on core patient-reported outcomes highlights the importance of disease-related symptoms and physical function in trials. It reflects a broader trend of incorporating patient experience as trial endpoints, particularly in cancer. Traditional clinical trial guidances, like those on informed consent and data integrity, focus on ensuring high-quality, reliable data.

FDA’s draft guidance on multiregional oncology trials advises on using foreign populations for US disease state representation. The guidance aligns with FDA’s broader move toward global clinical trial coordination. In the combination products space, FDA issued guidances on drug delivery devices and use-related risk analysis, underscoring the complexity of modern products.

Overall, FDA’s 2024 guidance efforts strike a balance between traditional clinical practices and emerging methodologies. The agency provided more detailed guidance on established GCP areas while offering clarity on innovative approaches for data development. This trend is expected to continue as FDA explores the use of AI in drug development and works toward more efficient clinical trial designs.

Current and Anticipated Measures in FDA’s Expedited Programs

The recent guidance on “Accelerated Approval – Expedited Program for Serious Conditions” outlines conditions for the initial approval, including endpoints, evidentiary thresholds, and confirmatory trials. The agency has updated its procedures for withdrawing products approved under accelerated pathways, with a focus on confirmatory trial outcomes. However, the guidance does not specify when FDA might exercise discretion in withdrawing products when trials fail to meet endpoints, despite an increasing number of such trials.

Looking ahead, the FDA plans to publish a guidance on the evidentiary framework for biomarker qualification, expanding the use of accelerated approval beyond oncology and infectious diseases. The agency is also working on two more guidances: one on priority review voucher programs, aiming for transparency and consistency, and another on the Qualified Infectious Disease Product (QIDP) designation, which incentivizes the development of antibacterial and antifungal drugs.

Leadership Shifts and Policy Changes: Examining How the Presidential Transition and FDA Departures Could Impact Drug and Biologics Regulation in 2025

The ongoing presidential transition is bringing changes to the FDA’s leadership and operational dynamics. While most FDA staff remain unchanged during transitions, appointed roles like FDA Commissioner often shift between administrations. These positions are filled temporarily until formal appointments and Senate confirmations are completed, which can take weeks or months.

Key leadership changes have already occurred within the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Longtime leaders, including CDER Director Dr. Patrizia Cavazzoni and Deputy Directors Dr. Celia Witten and Dr. Douglass Throckmorton, have recently departed. Their departures leave critical roles unfilled, raising questions about future leadership and potential structural shifts in these centers.

While core FDA activities like application reviews and inspections continue, some processes, like issuing new guidance, may temporarily slow. For instance, in 2024, the FDA released guidance on addressing misinformation about medical devices and prescription drugs. This document highlights priorities like ensuring accurate product information amid evolving communication channels, reflecting Commissioner Robert Califf’s focus on combating misinformation.

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