FDA Priorities for FY 22

During Dr. Woodcock’s presentation to the Alliance on April 14, she discussed priorities:

Q: "What major programs are you working to implement this year?"

A: "Well, our tech modernization is really major, both the data modernization and the infrastructure modernization. What are we doing? We are going to try to have enterprise-wide platforms and common data standards so our systems can talk to one another and we are not paying so much for individual siloed platforms."

Q: "Could [AI] provide a fundamental role in transforming our regulatory activities?"

A: "Yes, but first of all, you have to have data that the AI can work on, so that is where the data modernization goes. If we could target risk for imports so we could figure out with a smarter intelligence than human what to target, that would be terrific."

In the FY 21 budget request a year ago, FDA requested just over $10 million for “Artificial Intelligence and Other Emerging Technologies,” with monies directed to CDRH, ORA, CFSAN, and FDA/HQ. We would expect a more far-ranging proposal this year, but last year’s request provides insight into what might be in this year’s request.

MEDICAL PRODUCTS. “AI and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies, and significant improvements in personalized medicine. AI is also being evaluated to improve FDA’s targeting capability of products that may be hazardous to public health.”

FOOD SAFETY/COSMETICS/DIETARY SUPPLEMENTS. “The use of AI in post-market surveillance and signal detection will enhance CFSAN’s ability to detect potential problems associated with CFSAN commodities, including leveraging data to investigate outbreaks and potential issues with chronic, long-term consumption of food constituents and contaminants or long-term use of cosmetics. FDA will ultimately utilize this information to enhance the science that supports our guidance to industry for protecting public health. As a specific example, use of this technology in the post-market space will streamline the review of adverse event reports for foods, dietary supplements, and cosmetics so that FDA can act more quickly to intervene earlier, including by removing unsafe products from the marketplace.”

MEDICAL DEVICES. FDA has developed “a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence algorithms. The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices.”

“AI in medical devices promises to drive growth of the U.S. economy and improve patient safety and quality of life. For FDA to continue to lead the world in its approach for the smart regulation of these bold, new medical devices, it is imperative that…FDA leads the development of appropriate, consensus-based international standards to bring safe products to market in a predictable, efficient, transparent, and consistent manner.”

INSPECTIONS. “In 2019, FDA conducted an evaluation of AI/ML to strengthen FDA's capability to predict which shipments of imported goods, specifically seafood for this evaluation, pose the greatest risk of violation and, thus, increase the effectiveness and efficiency of import review resources. This proof of concept evaluated the performance and effectiveness of AI/ML and big data techniques for improving imports screening/targeting, beyond a traditional rule-based model, and developed recommendations for the future use of AI/ML and rules for screening/targeting.”

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH. “NCTR’s research provides FDA regulatory science to inform standards development, analysis, and decision-making for the safety of FDA-regulated products. NCTR conducts a full range of studies in support of FDA’s product portfolio. Within the area of Enhance Oversight, examples of NCTR research include … Artificial Intelligence …”

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.