FDA Plans to ‘Radically Increase Efficiency’ in Drug Approval Process Using AI

The FDA has unveiled a new strategy to expedite the approval process for drugs and medical devices by harnessing the power of AI, while also focusing on improving food safety and rebuilding public trust.

The New York Times reports that in a recent article published in the Journal of the American Medical Association (JAMA), FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the agency’s division overseeing vaccines and gene therapy, outlined the agency’s key priorities moving forward. Central to their plan is the implementation of AI to “radically increase efficiency” in the decision-making process for approving new drugs and medical devices. The FDA aims to accelerate the final stages of drug and medical device approval, reducing the process to a matter of weeks.

The FDA, which plays a crucial role in advancing the agenda of HHS Secretary Robert F. Kennedy Jr., is also set to review “concerning ingredients” that are present in U.S. food products but not in those of other developed nations. This move is in line with the agency’s recent push for food manufacturers to remove artificial food dyes from their products.

According to the JAMA article, the FDA’s focus will be on “delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust.” These objectives highlight the Trump administration’s efforts to facilitate major industries by streamlining processes to ensure products reach pharmacies and store shelves promptly.

However, some aspects of the proposed plan have been met with skepticism, particularly the notion that AI can significantly reduce the time required for the meticulous examination of applications submitted by companies seeking approval for drugs or high-risk medical devices. Stephen Holland, a lawyer who previously advised the House Committee on Energy and Commerce on healthcare matters, expressed his reservations, stating, “I don’t want to be dismissive of speeding reviews at the FDA. I think that there is great potential here, but I’m not seeing the beef yet.”

The FDA’s new strategy comes amid a Trump-driven reduction of nearly 2,000 employees, prompting agency officials to explore innovative solutions like AI to enhance efficiency and maintain the organization’s effectiveness in the face of diminished resources.