Meeting Highlights: DIA Global Annual Meeting 2023
A Year’s Worth of Progress: Insights from the FDA Town Hall 2023
Tamei Elliott
DIA
Sorcha McCrohan
DIA
F

DA has recently met several significant milestones which underline its commitment to public health and safety. This commitment was highlighted by the 1,000th label change made by the Office of Pediatric Therapeutics (within the last year) to ensure safe and effective medical products for children. FDA has also prioritized updating labels for opioids to provide greater clarity for when and how they should be used. FDA is also working to expand over-the-counter sales of hearing aids, drugs with conditions for nonprescription use, and other products.

In June 2023, FDA representatives RADM Richardae Araojo, Jacqueline A. Corrigan-Curay, Andi Lipstein Fristedt, and Hilary Marston convened at DIA’s Global Annual Meeting 2023 to discuss their respective centers’ priorities. Their discussion focused on several topics including a reflection on their past year’s accomplishments; global collaborative initiatives; efforts towards enhancing diversity, equity, and inclusion in clinical trials; the role of artificial intelligence (AI) and digital health technologies (DHTs); diagnostics; and what they see on their future horizons.

Global Collaborative Initiatives

Africa: FDA is determining how to best engage in the development of the African Medicines Agency (AMA), a specialized agency of the African Union (AU) established to harmonize medical product regulations and improve access to safe and effective products across Africa, and more broadly looking at unmet medical needs globally. AMA has announced its headquarters and operations in Rwanda and is working to establish a governing board and recruit a director general.

EU-US Health Task Force: The European Union (EU) and US have collaborated to form a task force focused on joint efforts in cancer research, addressing global health threats, and fortifying supply chains and infrastructure. As part of their strategic approach, two working groups have been formed: one targeting pediatric and young adult cancer; and another focusing on lung cancer prevention, detection, and treatment.

Mutual Recognition Agreements: FDA’s Office of Global Policy and Strategy has been engaged in expanding the oversight of products that the FDA regulates, including medical products, and advancing harmonization and global policy priorities. In 2017, FDA established a mutual recognition agreement (MRA) with the European Medicines Agency (EMA) on pharmaceutical good manufacturing practices (GMP) and recently expanded it to veterinary drugs. In February 2023, FDA entered into an MRA with Switzerland which offers the opportunity to leverage both agencies’ expertise. Thanks to MRAs, FDA was able to defer 300 inspections due to travel restrictions and deliver efficiencies to overcome other challenges of the pandemic.

Diversity, Equity, and Inclusion (DEI)

FDA’s Office of Minority Health and Health Equity (OMHHE) has threefold objectives for its Equity Initiatives: (1) enhancing equity in clinical trials by supporting the advancement of diversity within them; (2) maintaining equitable data efforts to increase research studies among diverse populations; and (3) promoting equity of voices to bolster the FDA’s communication with diverse populations and inform stakeholders about their efforts to better understand their perspectives, preferences, and unmet needs. With the passing of new legislation under the 2022 Food and Drug Omnibus Reform Act, the 2022 draft guidance on diversity plans, and (more recently) the August 2023 draft guidance on post-marketing approaches to obtain data on populations who have been historically underrepresented in clinical trials, there has been increased attention, momentum, and visibility for the imperative to increase diversity in clinical trials. Notable FDA priorities regarding DEI include:

Artificial Intelligence and Digital Health Technologies

FDA also highlighted the revolutionary potential of AI and machine learning (ML), particularly in improving drug development and manufacturing. By advancing two discussion papers (Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing) as part of its Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative, FDA aims to foster stakeholder dialogue and collaboration regarding best practices for AI and ML integration. These documents cover safety protocols, ethical challenges, and potential risks/rewards of using AI and ML in the biomedical field. FDA’s risk-based approach to AI and ML in drug development considers:

  • Human-led governance, accountability, and transparency;
  • Data quality, reliability, and representativeness; and
  • Model development, performance, monitoring, and validation.

Diagnostics

Diagnostics provide a cornerstone for effective medical decision-making, with the Centers for Disease Control and Prevention (CDC) reporting that diagnostics influence 70% of medical decisions. This significant impact makes the need for a contemporary framework for the oversight of laboratory developed tests (LDTs) quite evident. The VALID (Verifying Accurate Leading-edge IVCT Development) Act emerged to establish a modern regulatory framework for LDTs. As diagnostics continue to drive medical advancements, FDA is actively collaborating with legislators and the diagnostics industry to reform LDTs, ensuring that regulatory standards align with the evolving healthcare landscape.

Future Efforts for 2023 and Beyond

As outlined in FDA’s Unified Agenda-TRACK, which maintains an updated agenda of the FDA’s upcoming rulemaking, the FDA’s future efforts include regulations for over-the-counter drugs, biologics modernization, and oversight of direct-to-consumer prescription drug advertisements. A broader FDA priority is addressing misinformation and disinformation. Marston noted that the historical precedent of the FDA’s establishment in many ways was a response to misinformation. Compounded challenges of the COVID-19 pandemic and social media have only augmented this issue, articulated by FDA Commissioner Robert Califf as the “most significant public health threat of our time.”
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