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 Medical Devices Law & Industry Report, in “FDA Seeks Input on How to Review Certain Device, Drug Combos,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
The notice announcing the public meeting contains 12 questions for industry and others. “The questions presented in the Federal Register notice are very difficult questions that, as the agency points out, have policy, regulatory, public health, and legal implications,” Bradley Merrill Thompson, general counsel for the Combination Products Coalition (CPC), an industry group, told Bloomberg BNA Sept. 25.
The CPC participated in a previous meeting that the FDA held in 2005 on combined uses of products, Thompson said. “As the agency points out, much time has passed [since that meeting] and we’ve all learned quite a bit, so I think it is a very good idea for FDA to have this public meeting,” he said. Thompson is a Washington-based attorney with Epstein Becker & Green PC and a Bloomberg BNA advisory board member.
Thompson also applauded the agency for asking for input before publishing a proposal on its approach because “many stakeholders will have a lot of useful information that they can share.”
The CPC hasn’t dealt with these issues in a long time, so it will be spending the time between now and November thinking through these issues, “but we are very grateful for FDA to tee this up in such a transparent way,” Thompson said.