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 “Senate Bill Aims to Streamline FDA Approval of Combination Products,” which appeared in Bloomberg BNA’s Pharmaceutical Law & Industry Report.
Following is an excerpt (see below to download the full article in PDF format):
An attorney who represents makers of combination products said the bill addresses important concepts, but added that legislative changes may be premature.
Bradley Merrill Thompson of Epstein Becker & Green PC told Bloomberg BNA July 21 that the Combination Product Coalition “would like to focus our energies on working with FDA to improve the process administratively.” He is general counsel to the coalition.
Thompson said, “We have been meeting with FDA officials, and we find them to be very genuinely interested in improving the process. Indeed, they are so interested that they have recently completed a very significant internal study of how to make the process better. We hope, and frankly anticipate, that FDA will publish the results of that study and initiate a series of reforms to make the process work more smoothly. We want to collaborate with the agency on that effort.”