James Boiani Quoted in “Nicotine Replacement Trials and the App Effect”

Pharma & MedTech Business Intelligence's The Pink Sheet Daily

James A. Boiani, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “Nicotine Replacement Trials and the App Effect,” by Cole Werble. (Read the full version – subscription required.)

Following is an excerpt:

The US FDA has been sending signals over the past four months that it may be willing to consider products and recommendations for use that will stimulate new product development in the nicotine replacement therapy category.

The agency has listened to proposals for new formulations (oral mists), recommendations for concomitant use of different formulations (patches and lozenges) and longer treatment periods, even new indications such as reducing craving or relapse prevention.

Showing that new NRT products or formulations work, however, raises an interesting issue about the complications created by new digital technologies - especially coaching apps to help people trying to quit smoking.

That was one message from a regulatory attorney in late January at a Part 15 open public hearing on NRTs conducted by FDA.

Epstein Becker & Green attorney James Boiani identified two issues arising from the more frequent use of electronic coaching techniques to help people try to quit or cutback on smoking - both issues which may have relevance to other drug sponsors:

  1. The growing use of apps is creating confusion among NRT drug sponsors as to whether they need to reference or combine with a coaching app when submitting new products for FDA review, and
  2. The effectiveness of apps is creating a higher placebo bar for sponsors to surpass.

On the reference issue, Boiani pointed out that the agency’s medical device regulatory arm (CDRH, the Center for Devices and Radiological Health) has shown flexibility towards new coaching apps and digital behavioral support techniques.

“There’s been a proliferation of tools due to the hands-off approach of the Center for Devices in regulating these sorts of products, with the release of the mobile medical apps guidance in 2015,” Boiani observed. “These tools can provide more convenient, tailored approaches to receiving support while using NRT.” He noted that they replace and can surpass the “traditional phone bank support model.”