Coalition seeks more clarity from FDA on Cures Act provisions

As the Food and Drug Administration implements provisions of the 21st Century Cures Act, an industry stakeholder organization is urging the agency to ensure that final rules are consistent with congressional intent.



“The passage of the 21st Century Cures Act last year was an acknowledgement that our regulatory processes and statutory structures related to technology and data must be revised to allow innovation to flourish,” wrote Health IT Now, a coalition of patient, provider, employer and payer organizations, in a recent letter to the agency. “Many of these provisions now fall to the FDA to implement in a way that balances the transformative nature of technology with the FDA requirement that products be safe and effective.”

Stakeholders seek implementation of the law that facilitates third party certification of software, development of a process to evaluate real-world evidence and use of new innovations.

For instance, the law sets specific rules for what software functions the FDA can and cannot regulate based on patient safety risks, which will provide clarity for identifying low-risk IT that does not need to be regulated.

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Consequently, Health IT Now applauds an FDA proposal to create a pre-certification process for medical device developers demonstrating best practices; thus, they will be able to market products following a streamlined FDA approval process.

“It is unmanageable from both the developer and FDA perspective to go through the full regulatory process for each update—even just those deemed significant—when the develop and implementation cycle for a new software version is days or weeks, not months or years,” according to the coalition. “Further, it is detrimental to patient safety to delay for FDA approval the implementation of software fixes or upgrades that may improve functionality or fix bugs.”

The Health IT Now letter also noted that the coalition is pleased that the Cures Act establishes a program to evaluate potential use of real-world evidence that can speed new medical treatments.

“What we have lacked, however, has been a clear and consistent process and means to use data collected from sources such as wearables, disease registries or electronic health records in support of research and development. In implementing this provision, the FDA should place emphasis on expanding the scope of existing guidance documents to include the use of real world evidence in post-market surveillance to support new indications for existing products.”

Use of real-world evidence in pre-market regulatory decisions to support new treatments would be transformative, and the value to patients would be worth investments of time and resources, the group says. This would be better facilitated if the FDA promotes a common understanding of factors used to determine the reliability and applicability of real-world evidence. Health IT Now also urges the FDA to work with agencies and stakeholders to create a consistent system of recognition for reliable data and data sources.

The coalition in its letter also notes that most pharmaceutical products deemed as safe in preclinical testing later are found to be problematic during clinical trials. “New technologies that would allow scientists to “fail faster” would reduce waste, speed up innovation and most importantly, deliver safe and effective treatments to more patients who need them.” But what these technologies are is not specified.

The FDA declined to immediately comment on concerns raised by Health IT Now.