Rosen Quoted on Obstacles to Generic EpiPen

Partner David Rosen participated in a question and answer session with Reuter’s Westlaw, “Q&A: Foley & Lardner’s David Rosen on Obstacles to Generic EpiPen,” on October 24, 2106. The article discussed obstacles to getting a generic version of Mylan’s EpiPen on the market and how the U.S. Food and Drug Administration (FDA) can hasten the process.

In response to whether or not the FDA can help generic products reach the market, Rosen said, “They could facilitate them by having a little bit more interaction with the applicants, i.e., allowing them to come in for a meeting so they can address the issues and concerns with the developmental process and so they can understand FDA’s expectations. That will also help FDA understand and appreciate the developmental work that’s being done. Companies can get a little more guidance on what they’re doing and how they can meet FDA’s expectations for approval.”