Image

By: Robert M. Califf, M.D., Commissioner of Food and Drugs

At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential. Some in the nonscientific community may be surprised by the seemingly sudden amount of attention on AI. But for scientists and regulators, this issue is not new—we’ve seen it coming for a long time, and I’d like to catch up with you today on this exciting topic.  

AI Enables Extraordinary Advances in Medical Products and Food

AI has the potential to enable major advances in the development of more effective, less risky medical products and more nutritious food. To give you an idea of its impact, consider that since 1995 the FDA has received over 300 submissions for drugs and biological products with AI components, and more than 700 submissions for AI-enabled devices.  

Submissions have included aspects related to drug discovery and repurposing, enhancing clinical trial design elements, dose optimization, endpoint/biomarker assessment, and postmarket surveillance. These submissions also cover a growing diversity of medical devices that leverage AI to improve clinical workflows and patient experiences or outcomes in addition to sophisticated prediction algorithms. 

And the areas of nutrition and food safety are on the verge of a revolutionary improvement due to the combination of digitization, AI and growth in computing power.  

AI Technologies Facilitate Internal Operations and Regulatory Processes

The FDA is also exploring the use of AI technologies to facilitate our internal operations and regulatory processes, which could benefit both agency experts and the public by streamlining workflows and facilitating high quality, novel medical products more quickly reaching the patients who need them.  

At its most basic, AI can strengthen our operational systems and bring increased productivity, opportunity, and efficiency to our work, helping us process and analyze complex data faster, including data from medical imaging or digital health technologies, for example. We can free up staff by automating repetitive administrative functions and enable them to focus on more complex meaningful activities to weigh the evidence and arrive at better decisions. Our workforce should also have more time to explain those decisions to the public and learned intermediaries in the biomedical and clinical world.  

The AI landscape is expanding every day and there is a lot more to say on this topic. We’ve issued: “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” and I hope you’ll check it out. The paper reaffirms our commitment to promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.

Catch up with you next time.