How we plan to cut FDA drug approval time by months

Marty Makary is the commissioner of the Food and Drug Administration.
For more than a century, the U.S. Food and Drug Administration has been a global leader in advancing medical cures, but in recent years, its regulatory framework has become an obstacle to innovation. Cumbersome requirements, poor communication and regulatory creep have made the United States less competitive in the global race for new drugs and treatments. Meanwhile, countries such as Australia and China, with more streamlined regulations, have become go-to destinations for clinical trials and early drug testing. The shift poses a risk not just to U.S. competitiveness but also to national security. To address it, the FDA must modernize.
That's why I have just announced a pilot program that can slash the FDA's drug review time from 10 to 12 months to just one to two months. The program will make use of the idle time during clinical trials — time needed to see how the drug in question performs. Instead of submitting all the data at the end of a trial, qualifying manufacturers will be able to submit most elements of the application — including manufacturing details and drug labeling — while the trial is underway. The FDA will be able to review the early data and resolve any issues with the manufacturer at that time. Once the trial concludes, final data will be submitted. Then there will be about one month of FDA review, followed by a focused, one-day meeting with FDA scientists to reach a decision. This split-submission approach is entirely feasible — as shown by its success during Operation Warp Speed at the start of the covid-19 pandemic.
This novel program tackles a common pain point voiced during my national listening tour: inaccessibility of FDA reviewers for clarifying questions. Pharmaceutical CEOs repeatedly told me a simple 15-minute call with their reviewer could save months of wasted work. Our new program adopts a real-time communication model, eliminating guesswork. No more mind-reading; drug developers will get straight answers when they're needed.
As a surgical oncologist, I've experienced firsthand the benefits of team-based decision-making as a participant in 'tumor board' meetings where specialists collaborate to make critical decisions. A similar team approach can be applied at the FDA to evaluate the safety and efficacy of new drugs.
In my first 12 weeks leading the FDA, we've made significant strides toward modernizing the agency. One example is the launch of Elsa, a tool powered by artificial intelligence that helps FDA reviewers sift through thousands of pages of data in minutes, instead of days. This tool is already being used by thousands of FDA staff daily, enabling them to focus more on what matters most: scientific expertise. Elsa doesn't replace human judgment but accelerates the review process, making the FDA more efficient and responsive.
We're also speeding up approvals by phasing out outdated animal testing, replacing it with cutting-edge tools such as computational modeling and organ-on-a-chip toxicity testing, where a miniaturized, three-dimensional tissue mimics human function. These techniques are faster, cheaper and better at predicting human toxicity. Notably, about 90 percent of drugs that pass animal studies fail in humans. The FDA has even required animal studies on drugs already approved in Europe. We need both gold-standard science and common sense. Newer methods can be more predictive and humane.
For drug developers, time is money. A previous valuable priority review program for rare pediatric diseases shortened FDA review time from 10 to 12 months to six. The market value of the six-month review was approximately $100 million to the pharmaceutical companies, showing that faster approval processes can be highly valuable. A one-month review process could be significantly more valuable and could incentivize companies to act on national priorities. These could include boosting domestic manufacturing for national security, addressing unmet public health needs or developing products for pandemic preparedness.
The new national priority review program is designed to align speed, science and strategy. It rewards companies working on innovative solutions to real challenges faced by the American public, without sacrificing safety or the FDA's rigorous standards. By modernizing the FDA, we can ensure that the future of medicine is written in the United States.
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