Bradley Merrill Thompson Quoted in “Wellness Draft Guidance Does Its Jobs, Industry Group Says”The Gray Sheet January 26, 2015
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Wellness Draft Guidance Does Its Jobs, Industry Group Says,” Ferdous Al-Faruque. (Read the full version — subscription required.)
Following is an excerpt:
“I really love this guidance,” said Bradley Thompson, who heads the mHealth Regulatory Coalition. “FDA truly listened to the public in crafting this guidance.” …
“That’s exactly what FDA proposes to do. No longer does the mere mention of a disease in promotional materials mean that FDA may regulate it,” said Thompson. “FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases.” …
Thompson says the approach seems reasonable but adds he is not sure what the agency means by devices that raise novel questions of usability. “Usability is a pretty broad concept, and includes some pretty benign characteristics,” he said.
The one unfortunate aspect to the guidance from Thompson's perspective is that was produced only by CDRH and did not involve participation by other agencies such as the drug center. While getting input from other centers might have complicated the matter, it is an important consideration, he said, especially when considering combination products that may include drugs that would be aimed at improving general wellness such as smoking cessation products.
“So on the one hand, after years of waiting for this guidance, I’m grateful that CDRH did not wait any longer to try to bring the other centers on board. But on the other hand, I’m always a bit sad when policymaking is done piecemeal,” said Thompson. “I really hope this does not mean that the other centers are on a different page.”