Putting the FDA on Your Defense Team

Jessica Benson Cox spoke on “Putting the FDA on Your Defense Team” at DRI’s Drug and Medical Device Seminar. In fiscal year 2023, the cost of some new drug applications (NDAs) will exceed $3.2 million. That investment is in addition to the extraordinary effort required to collect the efficacy and safety data required to support any NDA — efforts that often require many years, many researchers, many clinical trial participants, and hundreds of millions of dollars. The medical device premarket approval (PMA) and 510(k) processes similarly require millions of dollars of investment.

The session discussed the NDA and PMA approval, and 510(k) clearance processes, focusing on how the tremendous efforts required can yield helpful defenses (e.g., preemption, labeling adequacy). These can help identify ways to translate those efforts into a jury-friendly defense that helps demonstrate the safety and efficacy of a defendant’s FDA-approved drug or device, or that a device is as safe and effective as an already marketed device.