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US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

 

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Two US senators have sent a letter to US Food and Drug Administration officials that raises new concerns about the agency’s legislative plan for a conditional progressive approval pathway for medical devices.

Democrats Elizabeth Warren of Massachusetts and Patty Murray of Washington State – both members of the Senate Health, Education, Labor and Pensions (HELP) Committee – said in their 4 November letter that they’re worried about how the agency intends to maintain device safety and efficacy through use of a progressive regulatory pathway.

The FDA in April 2019 proposed the pathway’s creation, which appeared to be “strikingly similar” to a conditional approval pathway for certain animal drugs, the senators told acting FDA Commissioner Brett Giroir and FDA device center director Jeff Shuren in their letter.

The conditional approval pathway lets manufacturers make certain animal drugs available on the market after demonstrating a “reasonable expectation of effectiveness,” rather than the stricter “substantial evidence of effectiveness” standard currently required for full human-drug approval, Warren and Murray said.

“Progressive approval would weaken initial approval standards and allow certain medical devices onto the market before … completely demonstrating the device’s safety,” Warren and Murray wrote. The duo noted that the FDA had cited unmet needs for pediatric medical devices in justifying its proposal – but Warren and Murray raised questions about how the new pathway proposal would address those needs while maintaining safety and efficacy standards for medtech products.

Lawmakers Prod FDA On Postmarket Data Collection
Among the questions that Warren and Murray asked in their letter was what type of oversight the FDA envisions conducting on a progressive approval pathway to ensure safety standards are met, and how the agency would make its postmarket surveillance of progressively approved devices effective. They noted that an independent audit of the agency’s expedited approval pathways by the Department of Health and Human Services (HHS) revealed challenges with the FDA implementing postmarket requirements.

The senators also asked what real-world evidence would be sufficient to demonstrate a reasonable assurance of safety and effectiveness for devices reviewed under the progressive approval pathway, and if the FDA had ever relied exclusively on real-world evidence to support approval or clearance of a device.

Warren and Murray also wanted to know if device registries are sufficiently widespread and well developed so the agency can rely on them for data collection.

They also wrote that they are “disappointed by FDA’s clarification that the agency no longer fully stands by former commissioner [Scott] Gottlieb’s commitment that the ‘FDA does not believe this … pathway would be suitable for human medical products,’” and added that they continue to have questions regarding the eligibility criteria that FDA has in mind to carry out the conditional approval pathway proposal.

Warren and Murray of late have been sending several letters to the FDA regarding its handling of devices and other medical products, including a letter in late October questioning the agency’s regulation of digital devices. (Also see "US Senators Lay Out Concerns On FDA Digital Health Device Precertification Program" - Medtech Insight, 31 Oct, 2019.)

The lawmakers asked the FDA to respond to its progressive approval pathway letter by 13 November.

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