The Food and Drug Administration is looking to cut down on the time to bring new products to market, two of the agency’s top officials said on June 10.
FDA reviews that usually took a year were completed in weeks during the COVID-19 pandemic, which is “clear demonstration that rapid or instant reviews are possible,” Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a viewpoint published by the Journal of the American Medical Association.
A pilot program will look to speed up the timeline by taking steps such as asking companies to submit much of their paperwork to the FDA before they file their final application, which will enable FDA staff “to examine the manufacturing plans, draft labels, and packaging before a clinical trial is complete,” the officials added.
Makary and Prasad also said that there are antiquated processes, such as the requirement that companies submit monographs, or recipes for drugs, which they said have resulted in no changes to the recipe for infant formula since 1998, with the exception of adding selenium.
“We will rapidly usher to market new products with transformational potential,” they wrote.
In a video discussing the article, Makary said that it’s typically assumed that it takes 10 years from the development of a drug to when it can be sold.
“If you had the cure for breast cancer, do we really think it should take 10 years or even six years for that product to come to market?” he asked.
Still, the officials said they wanted to make sure to keep some requirements in place.
“If you lower the regulatory hurdle to have no barrier whatsoever—that is, you have no process—then you have snake oil out there, and you have people who pay a lot of money for false hope,” Makary said.
The viewpoint summarized priorities for the FDA under new leadership. Makary, nominated by President Donald Trump, was sworn in on April 1. He later hired Prasad, a professor and researcher, to lead the FDA center that evaluates vaccines and other biological products following the resignation of Dr. Peter Marks.
The FDA in recent months has already enacted a number of changes, including ramping up the use of artificial intelligence and moving to end the use of artificial dyes in foods and beverages.
Makary and Prasad said the availability of health data is another key to their vision of an improved FDA, which will no longer rely solely on data from randomized clinical trials to make decisions.
“Advances in causal inference in nonrandomized data, including the use of target trials, which attempt to balance confounding and time zero, have potential to yield actionable causal conclusions, in many cases at lower cost,” they wrote.
“Moreover, postapproval monitoring in Big Data will allow the FDA and researchers to see safety signals in real time and evaluate effectiveness in the real world. This is particularly important for products addressing rare diseases, where premarket randomized trials may not be feasible. Leveraging Big Data may also enable a broad move from a requirement for 2 pivotal clinical trials used by FDA regulators for many products in the past down to 1.”
The pivot will involve becoming an FDA that is more “user-friendly” and “partners with industry rather than takes a receive-only posture,” Prasad said in the video.
The officials also said they would take care not to become too close to pharmaceutical companies, which “has characterized the agency in the past and led to allegations of industry capture,” he added.