Sharpless outlines FDA’s key priorities for advancing public health
Four months into his tenure, Acting FDA Commissioner Ned Sharpless sent an email to FDA staff on Tuesday outlining four main priority areas: assuring public health through emerging technologies, investing in the FDA’s next generation expert workforce and infrastructure, modernizing frameworks and promoting and protecting consumer and patient safety.
On the emerging technologies front, Sharpless discussed how the FDA is trying to stay ahead of the curve while encouraging industry to adopt less costly and more reliable advanced manufacturing platforms.
“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,” he wrote.
Sharpless also declared hiring as an “immediate priority,” as other officials have lamented the gaps in the FDA’s workforce.
“We will be deploying the 21st Century Cures hiring authority at much greater scale. Simply put, we need to recruit, develop, and retain world- class people, and will be announcing more specific plans in these areas soon,” he wrote.
On modernizing frameworks, Sharpless touched on the FDA’s work to speed generic drugs and biosimilars to market to lower drug prices and noted work to try to help industry with “the most expensive part of drug discovery and development,” which is the clinical testing.
“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 wrote.
Real-world evidence, a topic discussed last week at an FDA event, will also help with pre- and postmarket adverse event detection and efficacy analyses 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,” he added.
As far as patient safety, Sharpless reiterated the FDA’s interest in strengthening post-market surveillance.
“For instance, novel machine learning algorithms can allow us to prioritize international mail inspections to better detect illicit opioid shipments; blockchain can help us track and trace food outbreaks with greater speed; and augmented track and trace technologies can help us improve the safety of drugs, devices, and veterinary products,” he wrote.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.