CDS Coalition Petitions FDA for Guidance on Drug Treatment Software

One of medicine’s most exciting new frontiers lies at the intersection of digital health technology and pharmaceuticals.  Widespread advances in wearable sensor technology, the Internet of Things, medical care, and pharmaceutical care have made conditions ripe for dramatic improvements in how we use pharmaceuticals.

Researchers in universities, pharmaceutical companies, technology companies, and health systems are developing products that use digital technology to promote the optimal use of pharmaceuticals.  Product development focuses on key clinical needs such as medication adherence, disease management, and clinical guideline interpretation.

According to the Clinical Decision Support (CDS) Coalition, lack of clear regulatory guidance from the Food and Drug Administration (FDA) is holding back this wave of innovation.

POLITICO reports that the CDS Coalition filed a citizens’ petition with the FDA in mid-August. The petition calls on the FDA to release long-promised guidance on clinical decision support software for programs that assist drug treatment.

The petition complains that current FDA guidance does not provide a clear pathway for digital health products used with pharmaceuticals. Product developers need to know whether software and wearables could constitute medical devices in the FDA’s view. If the FDA considers these products medical devices, under what circumstances will the marketing of these products trigger combination product status?

The CDS Coalition’s petition contends, “The existing uncertainty results in viable, technically sound and potentially clinically valuable projects languishing or being abandoned because the businesses considering them cannot estimate the development costs or timeline without a clear sense of the regulatory pathway.”

According to POLITICO, CDS Coalition’s general counsel, Bradley Merrill Thompson of Epstein Becker Green, indicated that “the group’s frustration stems from the agency’s propensity to give case-by-case responses rather than advance more general principles.”

“Industry simply cannot go through a consultative process every time we contemplate a new product, or change direction in product development. We have to know the rules of the road,” Thompson said.

Thompson noted, however, that traditional guidance may be a poor fit for CDS software. Providing guidance for a broad area like clinical decision support requires the FDA to come up with “principles that describe everything from simple stuff to complex operations.”

The petition recommends instead that the FDA issue “advisory opinions,” a common FDA practice prior to the 1990s.  Using this approach, the agency would issue opinions on various case studies.

The CDS petition presents the FDA with three detailed “use cases” for software that guides the use of pharmaceuticals and asks the FDA to provide “case study guidance” by answering 26 questions related to regulation.


Click here to read the CDS Coalition’s Citizens’ Petition.

Click here for POLITICO’s discussion of the CDS Coalition’s citizens’ petition.




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