Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report, in “Device Center Leader Asks If FDA Should Develop User Fee Goals for Combo Products.”
Following is an excerpt:
When a manufacturer submits a combination product to the FDA for approval or clearance, it’s assigned to the agency’s drug, device or biologic center, based on its primary mode of action, Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC in Washington, told Bloomberg BNA in a June 18 e-mail. The center assigned the combination product then typically applies its own authorities to the product, but also consults the other centers for their expertise, he said.
According to Thompson, the current system “seems to be working fairly well.” Thompson serves as the general counsel of the Combination Product Coalition (CPC), which is an industry group.
The only issue related to user fees for combination products, “to my knowledge, is whether the center that collects the fee is willing to share a portion of it with the center that is helping doing the review,” Thompson said.
“While it seems fair to me that the centers would share their fees,” that is largely an internal matter that the CPC leaves to the FDA, he said. Instead, he said, the coalition’s concern is simply making sure that during the course of a combination product review, the issues are addressed by those who have the necessary expertise.