Makary Updates First 100 Days Leading FDA

FDA Commissioner Marty Makary issued a statement today (July 10) to update the work that has been accomplished in his first 100 days leading the organization and create a roadmap for future objectives.

“The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American,” he said. “Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science, and common sense.”

The statement then listed dozens of bullet points highlighting the work being done, the majority of which focused on pharmaceuticals and food manufacturing. Under the heading “Administration – Gold-Standard Science & Common Sense,” Makary said the FDA was protecting American consumers by combating illegal vapes. “In collaboration with U.S. Customs and Border Protection, seized nearly $34 million worth of illegal, youth-appealing e-cigarette products originating in China,” it said.

Makary also pointed to the FDA’s implementation of AI to assist all departments in reviewing products, of particular interest to the nicotine industry that has dealt with years of little to no movement regarding vapes and alternative products.

“Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork,” the statement said. “Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes.”

“I’m excited by what the talented FDA team have been able to achieve in 100 days by embracing gold-standard science, radical transparency, and common sense,” Makary said. “This is just the beginning. We’ll continue to introduce initiatives to modernize the agency.”

Read the entire press release here.