[{"innerBlocks":[],"name":"core\/freeform","postId":1515,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"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<\/b>: FDA looks to bolster regulatory decisions using real-world data<\/a>

The new funding for NEST will help to \u201cadvance a more rapid build-out\u201d of the system, according to the FDA, providing the ability to more rapidly detect \u201cemerging 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.\u201d

While progress has been made in implementing NEST, the regulatory agency contends that the system requires additional funding to achieve its full potential.

\u201cFor NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential,\u201d said FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA\u2019s Center for Devices and Radiological Health, in a written statement.

\u201cIndeed, funding is the principal barrier to establishing this system,\u201d added Gottlieb and Shuren. \u201cTo bridge the gap, the President\u2019s 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.\u201d

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\u2019s skeptical that Congress will \u201ccough up\u201d the millions of dollars in additional funding the agency says it needs for the system.

\u201cThey try to sell this on the basis of being able to bring products to market quicker if they have a better safety net,\u201d observes Thompson. \u201cI\u2019m not sure how many people are actually buying into that promotional claim by FDA.\u201d

Earlier this month, the NEST Coordinating Center (NESTcc)\u2014created in 2016 with a $3 million FDA award to the Medical Device Innovation Consortium\u2014initiated 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.

\u201cEnsuring the safety of medical devices on an ongoing basis requires a multi-layered effort,\u201d said Gottlieb and Shuren, who added that the FDA is \u201cseeking 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.\u201d

What is particularly troubling to Thompson is the FDA\u2019s stated desire to increase its power with regard to ordering post-market corrective actions, including recalls.

\u201cAfter 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,\u201d he adds. \u201cRecall 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.\u201d
","saveContent":"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<\/b>: FDA looks to bolster regulatory decisions using real-world data<\/a>

The new funding for NEST will help to \u201cadvance a more rapid build-out\u201d of the system, according to the FDA, providing the ability to more rapidly detect \u201cemerging 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.\u201d

While progress has been made in implementing NEST, the regulatory agency contends that the system requires additional funding to achieve its full potential.

\u201cFor NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential,\u201d said FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA\u2019s Center for Devices and Radiological Health, in a written statement.

\u201cIndeed, funding is the principal barrier to establishing this system,\u201d added Gottlieb and Shuren. \u201cTo bridge the gap, the President\u2019s 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.\u201d

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\u2019s skeptical that Congress will \u201ccough up\u201d the millions of dollars in additional funding the agency says it needs for the system.

\u201cThey try to sell this on the basis of being able to bring products to market quicker if they have a better safety net,\u201d observes Thompson. \u201cI\u2019m not sure how many people are actually buying into that promotional claim by FDA.\u201d

Earlier this month, the NEST Coordinating Center (NESTcc)\u2014created in 2016 with a $3 million FDA award to the Medical Device Innovation Consortium\u2014initiated 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.

\u201cEnsuring the safety of medical devices on an ongoing basis requires a multi-layered effort,\u201d said Gottlieb and Shuren, who added that the FDA is \u201cseeking 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.\u201d

What is particularly troubling to Thompson is the FDA\u2019s stated desire to increase its power with regard to ordering post-market corrective actions, including recalls.

\u201cAfter 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,\u201d he adds. \u201cRecall 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.\u201d
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FDA seeks $46M to fund National Evaluation System for Health Technology

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