The FDA Is Showing How to Deliver on the Promise of AI, Says ITIF

WASHINGTON—Following the Federal Drug Administration’s (FDA) announcement to unleash AI and harness big data as core new priorities, the Information Technology and Innovation Foundation (ITIF), the leading think tank for science and technology policy, released the following statement from Senior Policy Manager Hodan Omaar and Vice President for Global Innovation Policy Stephen Ezell:

The FDA’s new approach to AI and data exemplifies what it means to make AI work for the American people.

America lags in health outcomes, not because it lacks health innovation, but because breakthrough treatments get stuck in red tape, become unaffordable by the time they reach patients, and existing systems for tracking effectiveness in the real world haven’t kept up with the tools now available to do the job better.

The FDA's approach isn’t just using AI to improve how medical innovation is developed, it’s using AI to fix the broken pipeline that prevents those innovations from benefiting patients. It’s using generative AI to speed up how it reviews new treatments, so promising drugs don’t get stuck in bureaucratic limbo. It’s using AI modeling to replace slow and expensive animal testing, which helps make lower-cost versions of existing drugs easier to develop. And it’s applying real-world data tools to better monitor treatment outcomes after approval. By directing AI toward the longstanding bottlenecks that have prevented world-class medical breakthroughs from improving lives, the FDA is setting a clear example of what it looks like to set AI priorities squarely on public benefit for everyday Americans. This approach should serve as a blueprint for other agencies seeking to mobilize AI for tangible progress across the nation.

However, even with these advances, the affordability of medicines remains a critical, unresolved policy challenge. The FDA is correct that other OECD nations are not paying their fair share for innovative medicines. But the answer is not to adopt a “lowest-common-denominator” approach, it's to push other nations to contribute more fairly. At the same time, U.S. policymakers need to recognize that more than 50 cents of every dollar spent on prescription drugs in the U.S. doesn’t go to the companies driving innovation and manufacturing, but to other stakeholders in the value chain. Policymakers need to forge solutions that promote the affordability of medicines without depriving industry of the revenues needed to undertake the risky, uncertain, multi-billion-dollar enterprise of innovating new-to-the-world drugs.

Contact: Nicole Hinojosa, [email protected]