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Compliance In Focus
Posted by Ellisyn Scott on Tue, Feb 18, 2020

FDA’s Progressive Approval Pathway: Pros and Cons

PathwayThe Food and Drug Administration (FDA) proposed a conditional progressive approval pathway for medical devices in April 2019. The proposal has met resistance by lawmakers and there are still unanswered questions.

The FDA intends for this approval system to be used in cases to treat life-threatening or irreversibly debilitating diseases particularly in children and other underserved populations. For a device to stay on the market, manufacturers would have to collect post-market data through real-world data via registries and electronic health records in order to have oversight of the device’s safety and efficacy. The proposal is not intended for all human medical devices, but for ones geared towards populations in need of clinical trial attention. The goal is to conditionally approve these devices for patients to receive some type of intervention instead of none. It has been questioned what efforts have taken place to implement this approval process and the FDA has reassured lawmakers that no steps have been put into action because they have not gained the authority to do so yet.

Democrats Elizabeth Warren of Massachusetts and Patty Murray of Washington State are both members of the Senate Health, Education, Labor and Pension committee and have taken lead in following-up and questioning the FDAs proposal. Their main concern is how the FDA plans to maintain device safety and efficacy using this progressive regulatory pathway. “Progressive approval would weaken initial approval standards and allow certain medical devices onto the market before… completely demonstrating the devices safety,” Warren and Murray wrote in one of their letters to the FDA. They also expressed their disappointment in the agency for not standing by former commissioner Scott Gottlieb’s commitment that the ‘FDA does not believe this pathway would be suitable for human medical products.’

The senators responded to the FDA on November 4th, 2019 with many follow-up questions focused around the eligibility criteria, how the FDA plans to secure quality of data collection, and the ability to exercise removing medical devices from market after they have been provisionally approved.

What questions do you have regarding the proposal? Do the benefits outweigh the risks or should initial approval standards remain in place regardless of the population?

Executive Summary

photo credit: djk_paulus Subtle Island via photopin (license)

Topics: Medical Devices, FDA Approval Pathway

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