FDA seeks $46M to fund National Evaluation System for Health Technology
Agency says money needed to fully gather real-world evidence to make medical devices safer for patients.
The Food and Drug Administration is seeking $46 million in its fiscal year 2019 budget request to better enable its active post-market data monitoring system to gather real-world evidence for medical devices.
The National Evaluation System for health Technology (NEST), which leverages data from patient registries, Medicare claims, and electronic health records, is meant to provide critical information for assessing the safety and effectiveness of medical devices using real-world evidence.
Also See: FDA looks to bolster regulatory decisions using real-world data
The new funding for NEST will help to “advance a more rapid build-out” of the system, according to the FDA, providing the ability to more rapidly detect “emerging safety signals through active surveillance, supporting timely evaluation of these signals to determine if they represent a real risk to patients, and ensuring timely responses to new and increased risks.”
While progress has been made in implementing NEST, the regulatory agency contends that the system requires additional funding to achieve its full potential.
“For NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential,” said FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a written statement.
“Indeed, funding is the principal barrier to establishing this system,” added Gottlieb and Shuren. “To bridge the gap, the President’s budget for fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as to conduct FDA-sponsored post-market studies that address device-specific safety concerns. If this funding becomes a reality, the FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term.”
However, Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, believes this is a tough political climate for the FDA to raise as much money as they are requesting for NEST.
He’s skeptical that Congress will “cough up” the millions of dollars in additional funding the agency says it needs for the system.
“They try to sell this on the basis of being able to bring products to market quicker if they have a better safety net,” observes Thompson. “I’m not sure how many people are actually buying into that promotional claim by FDA.”
Earlier this month, the NEST Coordinating Center (NESTcc)—created in 2016 with a $3 million FDA award to the Medical Device Innovation Consortium—initiated eight test case demonstration projects using real world data for post-market surveillance. The test cases include testing the feasibility of using patient registries and claims data to evaluate the safety and effectiveness of total joint and knee replacement surgeries.
“Ensuring the safety of medical devices on an ongoing basis requires a multi-layered effort,” said Gottlieb and Shuren, who added that the FDA is “seeking new authority for faster and more efficient imposition of post-market safety mitigations and efforts to further assure the safety and effectiveness of devices reviewed under the 510(k) process.”
What is particularly troubling to Thompson is the FDA’s stated desire to increase its power with regard to ordering post-market corrective actions, including recalls.
“After doing this work more than 30 years, while I have seen much frustration in industry about slow and difficult new product approvals, I've seen far greater damage done to companies when FDA decides that a recall is necessary when the company doesn't believe it,” he adds. “Recall decision-making is still very subjective, and FDA takes an extraordinarily cautious view at times. To give FDA greater power in this area is to give them the power to destroy companies for very little reason. As such, I am very afraid.”
The National Evaluation System for health Technology (NEST), which leverages data from patient registries, Medicare claims, and electronic health records, is meant to provide critical information for assessing the safety and effectiveness of medical devices using real-world evidence.
Also See: FDA looks to bolster regulatory decisions using real-world data
The new funding for NEST will help to “advance a more rapid build-out” of the system, according to the FDA, providing the ability to more rapidly detect “emerging safety signals through active surveillance, supporting timely evaluation of these signals to determine if they represent a real risk to patients, and ensuring timely responses to new and increased risks.”
While progress has been made in implementing NEST, the regulatory agency contends that the system requires additional funding to achieve its full potential.
“For NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential,” said FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a written statement.
“Indeed, funding is the principal barrier to establishing this system,” added Gottlieb and Shuren. “To bridge the gap, the President’s budget for fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as to conduct FDA-sponsored post-market studies that address device-specific safety concerns. If this funding becomes a reality, the FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term.”
However, Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, believes this is a tough political climate for the FDA to raise as much money as they are requesting for NEST.He’s skeptical that Congress will “cough up” the millions of dollars in additional funding the agency says it needs for the system.
“They try to sell this on the basis of being able to bring products to market quicker if they have a better safety net,” observes Thompson. “I’m not sure how many people are actually buying into that promotional claim by FDA.”
Earlier this month, the NEST Coordinating Center (NESTcc)—created in 2016 with a $3 million FDA award to the Medical Device Innovation Consortium—initiated eight test case demonstration projects using real world data for post-market surveillance. The test cases include testing the feasibility of using patient registries and claims data to evaluate the safety and effectiveness of total joint and knee replacement surgeries.
“Ensuring the safety of medical devices on an ongoing basis requires a multi-layered effort,” said Gottlieb and Shuren, who added that the FDA is “seeking new authority for faster and more efficient imposition of post-market safety mitigations and efforts to further assure the safety and effectiveness of devices reviewed under the 510(k) process.”
What is particularly troubling to Thompson is the FDA’s stated desire to increase its power with regard to ordering post-market corrective actions, including recalls.
“After doing this work more than 30 years, while I have seen much frustration in industry about slow and difficult new product approvals, I've seen far greater damage done to companies when FDA decides that a recall is necessary when the company doesn't believe it,” he adds. “Recall decision-making is still very subjective, and FDA takes an extraordinarily cautious view at times. To give FDA greater power in this area is to give them the power to destroy companies for very little reason. As such, I am very afraid.”
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