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 “Senators Want to Fix FDA’s Inspection Process for Device Companies,” 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 Feb. 21 e-mail “at a high level, this bill seeks to address some significant themes involved in device inspections.” Thompson counsels medical device, drug and combination-product companies on a wide range of FDA issues.
“First, there has always been a tension between the auditing function of such inspections, and the law enforcement function of such inspections,” Thompson said.
Thompson said “audits, when done by third parties to achieve certification to a standard, are very predictable and well-organized. The auditors come in and do a comprehensive check, with significant advance notice and planning. They follow rigorous and written procedures in conducting the audits, with significant communication.”