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 Rolls Out New Rx-Use-App Paper,” by Mohana Ravindranath.
Following is an excerpt:
Many apps that offer information about prescription drug use wouldn’t require FDA approval before going on the market, the agency proposed in a new concept paper Monday.
Apps offering or tracking basic information, such as symptom trackers, wouldn’t require agency pre-approval, but would need to meet post-market requirements for promotional drug labeling. But apps offering significant changes to clinical outcomes would likely require more review. The agency thinks most of these apps would fit the former category.
Products that have already been reviewed by the agency’s device center likely wouldn’t face scrutiny from the drug office.
Developers had long griped about differences in standards between the agency’s drug and device offices, and the proposal — a prelude to later draft guidance — addresses that.
Bradley Merrill Thompson of Epstein, Becker and Green said he was glad the agency was starting to address the subject, but he still expressed significant reservations. The proposal only covers apps developed by drug sponsors in conjunction with their products, and Thompson says that independent companies need attention too.
“It is, though, nice to see the agency start to publish anything on software used with pharmaceutical products,” he wrote. “We just hope that we will see more soon.”
