Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products,” by Dave Muoio.
Following is an excerpt:
The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories.
The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely aligns with that product’s “primary mode of action,” as opposed to submitting multiple types of applications. The draft also includes suggestions and examples of which kinds of products would be most appropriate for each regulatory center. …
In the accompanying statement, Gottlieb specifically highlighted a sensor-enabled pill, patch and drug product (like the kind developed by Proteus Digital Health and approved by the FDA) as an example of a combination product that would fall under the new guidance. The FDA’s draft guidance document itself, however, did not include any clear examples of or scenarios related to digital health products, noted Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law.
“It doesn’t really contribute clarity with regard to digital health in particular,” Thompson wrote in an email to MobiHealthNews. “It basically is suggesting … that the agency is predisposed to believe that one regulatory submission will be appropriate for digital health combination products.”
Thompson characterized FDA’s preference for a single submission as bad news for an industry that so far prefers to submit multiple applications for its devices, so as to better match the varying stringency of each regulatory center.
“The reasons industry wants the option of filing two different submissions include the fact that two submissions might better ensure an appropriate risk-based review for both the device constituent part as well as the drug constituent part,” he wrote. “Insisting on one application for a drug led combination product — which likely means an NDA — means that the device constituent part might end up overregulated.
“This is especially true in the context of software. Software that helps guide drug use, if regulated under an NDA, may be subject to steeper requirements than if the software is reviewed in a coordinated review but submitted through a separate device application.”
Also worth highlighting is the fact that some novel digital health products qualifying as a combination product come from a commercial arrangement between a drugmaker and a software or device maker, Thompson continued. In these cases, many partnerships might prefer to draft and submit individual applications based on the component of the combination product with which they are most familiar.
“But this guidance seems to discourage that commercial arrangement,” he wrote. “Software and drugs, if they form a combination product, is through cross labeling which to me presents unique and different regulatory issues from single entity combination products or even co-packaged combination product kits. All in all, I’ll be reviewing it carefully, but I really don’t see helpful improvements from the standpoint of software used in tandem with pharmaceutical products.”
