Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “FDA Combo Products Guidance,” by Darius Tahir.
Following is an excerpt:
In another move sold as a big win for digital health, FDA released a new draft guidance Tuesday aimed at boosting combination products. For a brief explainer: a combination product is one in which two different therapies straddling the different FDA taxonomies (drug, device, biologics) are melded into one product. One popular digital health example: putting a tracker on a pill to see whether the user actually ingests the therapy as directed.
The guidance says that, generally, companies only must submit one application even if it’s reviewed by multiple FDA branches.
Commissioner Scott Gottlieb, in a release, pointed to several potential digital devices as a rationale for the guidance, citing digital pills and mobile apps. If it’s true, digital developers will be pretty pleased; we wrote in 2016 that entrepreneurs were frustrated that the agency’s device division had different standards than its drug division, which was demanding voluminous extra data.
But some observers aren’t entirely convinced by the draft. Bradley Merrill Thompson, a digital health lawyer with Epstein Becker and Green, wrote to your correspondent noting that while Gottlieb’s statement mentions digital health, the guidance does not. “So it doesn’t really contribute clarity with regard to digital health in particular,” he said. Moreover, Thompson doesn’t believe a single application solves the over-review problem raised by entrepreneurs; nor does it address the reality that the drug maker and digital product developer might be separate entities.
“I really don’t see helpful improvements from the standpoint of software used in tandem with pharmaceutical products,” he concluded.