Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Politico Morning eHealth, in “FDA Releases Draft Patient-Experience Data Guidance,” by Darius Tahir.
Following is an excerpt:
The new agency guidance regarding patient-experience data in drug development includes few details about using digital health tools as a means for collecting that information. The agency says that companies interested in using digital apps or gadgets to gather the data should consult with the agency.
Conceptually, patient-experience data is information regarding how patients react to drugs beyond traditional metrics, like mortality and morbidity, that seeks to capture other important factors how patients feel about therapies they’re taking. For example, a patient might become more active when taking a drug.
Digital health enthusiasts have long felt their gizmos could play a role here; for example, a smartphone might be able to measure the increase in steps taken during a study period. But the guidance simply says that groups interested in using those technologies for gathering the data should consult with the agency first.
Some industry observers we chatted with were puzzled by the scanty detail — described over two sentences — in the guidance. “FDA really doesn't explain what [its] concerns might be with digital health technologies,” said Epstein, Becker and Green lawyer Bradley Merrill Thompson. “It would have been much more useful if FDA articulated what [their] concerns were, rather than just saying, hey come talk to us.”
