FDA Outlines “Priorities for a New FDA”

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On June 10, Food & Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad an article outlining their “priorities for a new FDA.” The two said that while “the US leads the world in sophisticated cell and gene therapies and other innovative treatments…in terms of the health of the population, [the US] medical system has been a 50-year failure,” citing a rise in chronic disease and a decline in life expectancy. They insist that fresh ideas and innovative approaches are needed to address the root causes of this chronic disease epidemic. To do this, they focus on five key areas:

• Accelerating Cures. FDA will evaluate its review processes and intends to pilot programs that speed up approval for new products “with transformational potential.” They also want FDA to become more “user-friendly,” supporting companies in navigating the federal bureaucracy while guarding against what they describe as “a cozy relationship that has characterized the agency in the past and led to allegations of industry capture.”
• Unleashing AI. FDA will use artificial intelligence (AI) to accelerate product reviews, modernize how it reviews AI-based technologies, and support new technologies that speed up drug development while reducing the need for animal testing.
• Healthier Food for Children. They assert that little research has been done on “arguably the most important potential root causes of chronic disease in the US: our chemically manipulated diet.” To correct this, FDA is conducting an inventory of “concerning ingredients” that are not allowed in other peer countries and will take action to remove harmful chemicals from the food supply and work on defining ultraprocessed foods. Notably, the article signaled that FDA will be taking a closer look at additives, such as talc, that are also used in drug production despite having known safety concerns.
• Harnessing Big Data. FDA will use “Big Data” and cloud computing to investigate the root causes of chronic disease and check for safety signals following product approval.
• Financial Toxicity. While recognizing that FDA is statutorily prohibited from considering price in benefit risk calculations, they promised that FDA “will use its power” to address high prescription drug costs. They also said that FDA is committed to supporting President Trump’s Most-Favored-Nations drug pricing efforts, and they expressed concern regarding direct-to-consumer advertising by pharmaceutical companies.

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