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 “FDA Seeks to Speed Approvals of Generic Drug-Device Combos,” by Bronwyn Mixter.
Following is an excerpt:
New FDA guidance will make it easier for generic companies to get drug-device combination products approved.
The final guidance will explain the issues generic applicants should consider when design differences between a generic version of a branded drug-device combination product could impact the clinical effect or safety profile of the generic product, Food and Drug Administration Commissioner Scott Gottlieb said recently.
Overall, the draft guidance “does a good job of clarifying the approval pathway for generic drug-device combination products. However, we hope that the final guidance improves on the draft in certain respects,” Bradley Merrill Thompson, general counsel for the combination Products Coalition, an industry group, told Bloomberg Lawin a Dec. 5 email.
For example, Thompson said, the FDA should promote a tiered approach based on a risk assessment to determine the impact of the differences between a proposed generic product and the branded product rather than the binary approach described in the draft guidance. The risk assessment could describe the differences as catastrophic, critical, serious, minor, or negligible, he said. The binary approach in the draft describes the differences only as impact or no impact. Thompson also is a Washington-based attorney with Epstein Becker & Green PC and a Bloomberg BNAadvisory board member.
