Good news! Drug approval processes in Western countries are way too long for way too many years.
"The FDA will use AI to “radically increase efficiency” in approving new drugs and devices, per a commentary published in JAMA; the adoption of the technology comes after the agency cut nearly 2,000 employees."
"Why does it take more than 10 years for a new drug to come to market? Why are childhood chronic diseases so prevalent? And how can regulators adapt to meet the challenges facing clinicians today? These questions are at the forefront for the US Food and Drug Administration (FDA).
The US leads the world in sophisticated cell and gene therapies and other innovative treatments, but in terms of the health of the population, our medical system has been a 50-year failure. Forty percent of US children now have a chronic medical condition and 1 in 6 has a neurodevelopmental disorder. Life expectancy has plateaued or fallen and is not commensurate with health care spending.
Over recent decades, obesity, diabetes, colon cancer, depression, and autoimmune diseases have increased in young people, and early-onset Alzheimer disease has increased by at least 300%. Historical and comparative global data do not support a genetic etiology for this rise, nor a deficit in willpower. Fresh new ideas are needed to address root causes and develop innovative approaches.
At the FDA, we will examine the role of ultraprocessed foods, food additives, and environmental toxins, the introduction of which has paralleled the epidemic of chronic diseases. We will transition from a purely reactionary health care system to one that is proactive, intellectually curious about underlying causes, and financially aligned to promote health—not just treat sickness. At the same time, the FDA must have the courage to create new pathways for therapeutic and device developers to respond to the current forest fire that is the worsening health of the US population. We will rapidly usher to market new products with transformational potential.
Here are our priorities for a new FDA. Each incorporates the 2 guiding principles of our philosophy—gold-standard science and common sense.
Accelerating Cures
During the COVID-19 pandemic, review processes that took a year were performed in weeks. We believe this is clear demonstration that rapid or instant reviews are possible. At the FDA, we aim to pilot programs to deliver sponsors a decision in weeks. Our pilot will leverage expertise across FDA divisions and departments. For efficiency, the pathway will ask sponsors to submit much of the arduous paperwork to the FDA in advance of their final application, enabling regulators to examine the manufacturing plans, draft labels, and packaging before a clinical trial is complete. The time from when pivotal trial results are known to when decisions are made must be shortened. This has implications for public welfare and will improve the risk-reward calculation of drug development.
In addition, we must reevaluate legacy processes at the agency that slow down decisions and do not increase safety. For example, monographs (required recipes for products) have stifled innovation in areas such as infant formula. As a result, there have been no changes to the infant formula recipe since 1998, with the exception of adding selenium. Europe and China are surpassing the US in some sectors. Reducing excessive, redundant, or uninformative animal testing is another area of interest.
To reinvigorate innovation, we must become a user-friendly FDA that partners with industry rather than takes a receive-only posture. Such a close relationship can provide guidance and predictability to developers and investors. In the case of small companies, the FDA can provide the regulatory navigation that companies may lack internally. At the same time, the FDA will guard against a cozy relationship that has characterized the agency in the past and led to allegations of industry capture. The scientific evaluation of products will always remain strictly independent.
For this reason, the FDA recently removed industry members of all FDA advisory committees where statutorily permitted. And at the recent Vaccines and Related Biologic Products Advisory Meeting, section 502 waivers (which waive voluntary disclosures) were not granted. The FDA will take conflict of interest seriously. We will never forget one of the worst self-inflicted wounds of US health care—the FDA’s illegal approval of oxycontin for chronic pain based on a 14-day study, the immediate hiring of the former FDA regulator by Purdue Pharma, and a subsequent epidemic that killed approximately 1 million people in the US.
Unleashing AI
The advent of generative artificial intelligence (AI) holds several promises to modernize the FDA and radically increase efficiency in the review process. From day one, we have made it a top priority, and on May 8, 2025, the agency implemented the first AI-assisted scientific review pilot using the latest generative AI technology. We believe AI can make a first-pass review of documentation received by the FDA as part of an application that often exceeds 500 000 pages and aid in generating standardized tables.
The FDA will also modernize how it reviews AI-based technologies. A diversity of use cases and rapid changes in technology make the legacy review mechanism appear byzantine. Rethinking our approach to AI, balancing safety and accuracy while fueling innovation, is a leading FDA priority.
Finally, we have developed a road map to reduce animal testing using AI-based computational modeling to predict toxicity-leveraging chip technology. These new technologies not only have the promise of better predicting toxicities in humans, but they can also speed up drug development and reduce animal waste and cruelty—another top priority. ..."
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