Evaluating Emerging Tech Is a Priority for FDA

Samara Rosenfeld
JULY 24, 2019
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It’s been nearly four months since the U.S. Food and Drug Administration (FDA) tapped Norman Sharpless, M.D., to serve as acting commissioner. Now, there is more clarity on the priorities of Sharpless while in his position.

Among his main priorities include assuring public health through emerging technologies, modernizing frameworks to enhance value for patients and consumers and promoting and protecting consumer and patient safety

“The world around us is changing rapidly, challenging us to adapt to increasingly complex global markets and advanced technologies,” Sharpless wrote in an email to the FDA. “What will not change is FDA’s commitment to protecting and promoting public health, and the priorities I have outlined will enable us to continue to do our jobs with agility.”
 

How the FDA Will Approach Emerging Tech

Health technology and innovations are changing the landscape of healthcare, and development is only going to continue accelerating.

Sharpless said the FDA sees the promise of technologies, including 3D-printed devices and cell-based therapeutics to deliver benefits to public health. The FDA will add more expertise in these areas to ensure optimal review and regulation of solutions developed from cutting-edge technologies.

The FDA will continue to develop frameworks so the agency can assess technologies for their safety and effectiveness. The standards will allow the FDA to look at the benefits and mitigate potential risks associated with such technologies.

The agency will also invest in the development of more modern and integrated information technology systems and advanced analytics. Sharpless said this could help reviewers, managers and investigators perform more efficiently.

And in a continued effort to advance data quality, the FDA will use more real-world and real-time data to better regulate products effectively.


Modernizing Frameworks to Decrease Healthcare Costs

The high costs for drugs and therapeutics limit patients’ access and can lead to rationing, lack of medication adherence and worsen outcomes.

Sharpless said the FDA will continue promoting more innovative clinical trial designs that are more efficient and will lower the cost of running a trial. This includes platform trials, basket studies, adaptive trials and pragmatic randomized controlled trials.

Real-world evidence can also be used for regulatory decision making to improve the generalizability of evidence to populations excluded from traditional clinical trials.
 

Promoting Patient Safety

The agency will use machine-learning algorithms to prioritize international mail inspections to detect illicit opioid shipments. The FDA will also use blockchain to track and trace food outbreaks more quickly. Augmented technologies could help the FDA improve the safety of drugs, devices and veterinary products.

“All the actions I’ve outlined aim to enhance FDA’s ability to execute across our regulatory portfolio with greater efficiency, allowing us to better focus on detecting, mitigating and preventing serious safety issues,” Sharpless wrote.

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