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The medical devices industry has seen a rise in the number of FDA approvals and guidance over the past months, and a prominent health-care attorney expects that to continue due to an agency commitment to speed up device approvals.
Faster device approvals by the Food and Drug Administration will benefit both patients and device makers, while creating minimal safety risks, Chad Landmon, an attorney at Axinn, Veltrop & Harkrider LLP’s Hartford, Conn., office, told Bloomberg Law in an early December video interview.
FDA Commissioner Scott Gottlieb told the Senate Health, Education, Labor and Pensions Committee earlier in December that the agency is on track to approve the highest number of novel medical devices in its modern history.
Landmon, chair of Axinn’s FDA practice group, said both Congress and the Trump administration are responsible for the agency’s new approach.
This administration is more focused on getting devices to market quicker than its predecessor, Landmon said. In draft guidance released in mid-December, the FDA set a new tone for the agency to use the most efficient and least burdensome means possible during the device approval process. The guidance appeared to be part of a larger initiative to change how the FDA handles approvals and clearances, and the agency said its goal is to reduce approval times, reduce costs on device makers, and spur innovation. Most devices reach the U.S. market through a clearance process based on similarity to other technologies, but novel and higher-risk devices need premarket approval.
Landmon said the 21st Century Cures Act, which became law in December 2016, is also to thank for the record number of new devices hitting the market.
“A lot of what we’ve seen with the record number of approvals are from things that were put in place prior to the administration,” he said. The Cures Act “really allowed FDA to staff up and get more people reviewing the products, and getting things to market quickly.”
The Cures Act established the FDA’s voluntary Breakthrough Devices Program to help patients more quickly obtain certain devices for life-threatening or debilitating diseases. Under the program, all submissions for breakthrough devices receive priority review and are placed at the top of the appropriate review queue and will receive additional review resources as needed. The FDA released initial draft guidance for the program in October, and in November it approved FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing-based in vitro diagnostic test that can detect genetic mutations in tumors.
A patient safety advocacy group has expressed concern that by reducing burdens on device makers, the FDA has prioritized quicker reviews over patient safety, and could be increasing burdens on patients and doctors.
“We all agree that FDA reviews should be as efficient as possible and not require extraneous information,” Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, told Bloomberg Law. “But FDA’s vision of reducing burdens to promote innovation too often means that new devices get on the market before there is scientific evidence that they are safe and effective in the short term or the long term.”
Landmon said FDA has not watered down its standards and that approval and clearance criteria may actually be getting more difficult.
“All FDA has done is put its focus on having an appropriate number of people there to do the reviews, on speed and communication back to the industry, and having better dialog with applicants in order to speed their products to market,” he said. “I don’t think that’s a real concern we need to worry about.”
The FDA has argued that more device approvals will mean more and better treatments, but Landmon said manufacturers will also see more money. Landmon mentioned that recently approved cancer therapies, as well as a December guidance on 3D printed (or additive manufactured) devicese, will allow for more precise treatments.
“Having medical devices that are actually tailored to patients just has so many benefits in terms of taking a product off the shelf that might fit depending on what you’re using it for,” he said. “Industry is certainly going to benefit from this as well.”
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