Sharpless Outlines Key Priorities for FDA
FDA acting commissioner Ned Sharpless has outlined key agency priorities that include supporting emerging technologies, investing in the agency’s next generation expert workforce and infrastructure, and promoting and protecting consumer and patient safety. In a 7/23 FDA-wide email, Sharpless said the agency’s guiding principles continue to be “that our efforts should rely on and be guided by science. Second, when wrangling with the complex issues the agency faces, we will keep top of mind our mission of protecting and promoting public health...”
With emerging technologies, Sharpless said FDA will focus on developing and applying “modern regulatory approaches for emerging technologies that protect consumers and patients while fostering timely access to important innovations. We see the promise of technologies like 3D-printed devices, cell-cultured food, cell-based therapeutics, and intentional genomic alterations to animals and plants to deliver enormous benefits to public health. As these fascinating technologies are developed, however, the FDA will also need to augment its expertise in these areas to afford optimal review and regulation of products derived from cutting-edge technology.”
Sharpless said the agency will develop scientific standards and tools needed to assess benefits and mitigate potential risks associated with emerging technologies, and will “encourage industry adoption of less costly and more reliable advanced manufacturing platforms, which can help prevent drug shortages and bring high-paying manufacturing jobs to the U.S.” To support cutting edge regulatory frameworks, he said FDA is investing in state-of-the-art and better integrated IT systems and advanced analytics to help reviewers and investigators perform their duties more efficiently. “This includes greater use of real-world and, in some cases, even real-time data to strengthen our ability to regulate innovative products effectively throughout the product life-cycle,” he said.
Additionally, Sharpless’ email said FDA will work to help industry with improving the clinical testing phase. “To expedite development of effective therapeutics and diagnostics, we will continue to promote the use of innovative clinical trial designs such as platform trials, basket studies, adaptive trials, and pragmatic randomized controlled trials that are more efficient and will lower costs of running trials,” he said. “We will also continue to promote the use of real-world evidence, both for pre- and postmarket adverse event detection as well as for efficacy analysis for clinical situations where randomized clinical trials may not be feasible. Enhanced use of real-world evidence for regulatory decision making will improve the generalizability of evidence to patient populations that may be excluded from traditional clinical trials.”