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 the Bloomberg BNA Medical Devices Law & Industry Report, in “Drug/Device Combo Makers Have Chance to Weigh in on FDA Policies,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told Bloomberg BNA in a Jan. 12 e-mail: “On the one hand, [the docket] is great. It is a clear avenue to raise issues. But on the other hand, in some ways it seems more about form than substance.” Thompson counsels medical device, drug, and combination product companies on a wide range of FDA issues.
“The public has always been free to send information to the director of the Office of Combination Products,” Thompson said. “And everyone I know is comfortable that OCP will share information they receive with the appropriate leadership.”
Thompson said the “FDA describes this docket as a one-way street, with no promised response.”
“If a member of the public files a citizens petition, they are promised a response. I’m not sure why someone would choose this docket over a citizens petition. Most people I know prefer some sort of response,” Thompson said. “If the Council wants to engage directly in communication with the public rather than rely on OCP, that communication should be a two-way street.”
Thompson said the OCP “has always been very open and approachable, and indeed willing to engage in dynamic exchange.”