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the firm. She is generous with her time and a great mentor. GJ: Coleen’s presence at the firm made it easy for me to join as I knew any endeavor she was a part of would be first rate, given her encyclopedic knowledge of food and drug law, keen judgment, and business savvy.
The life sciences industry, especially innovation in the genetics space, is moving at a rapid clip and is almost indecipherable to us laymen. With that said, should Congress be taking a more active role in crafting more suitable legislation for the industry? How does the FDA assist in legislative actions?
GJ: Congress generally works best when it sets broad mandates and draws clear lines of authority and the FDA is generally better at getting into the details. The genetics space has been challenging; there are unresolved questions about legal authority, what the existing rules are, and whether and to what extent new rules are needed. Uncertainty is a huge challenge for regulated industry, and can be a disincentive to innovation; ultimately, I would argue that it is not good for the public either. At Sidley, our role is to help our clients make the best legal decisions they can within this uncertain regulatory environment. When FDA is approaching a new technologic area from a regulatory perspective, it is vital to have input from the players in that space, which include the innovators themselves and the
potential users of the technology. A key ingredient to sound regulation is frequent communication b etween the regulated and the regulators, which fosters and facilitates information exchange. In the past, the FDA has effectively used rulemaking in approaching new technological areas; this has not happened in the genetics space but could be beneficial. CK: It is tempting to use legislation to try and guide or constrain the exercise of regulatory authority by the FDA. There are those who may feel that working through Congress is the best way to have a meaningful brake on the way the FDA acts. This isn’t going to be the case. It has been a long time since FDA was outmaneuvered on the Hill.
needs for both depth and scale-up are fully served.
What practice area of the firm best exemplifies the firm’s three pillar approach philosophy?
CK: Our Good Manufacturing Practice (GMP) practice is a good example of this perspective. We have the top team on global quality issues, because we can handle issues at a manufacturing plant for a client in any part of the world.
How are firms structuring their regulatory practices to accommodate clients and how is Sidley structured to help clients in the marketplace?
CK: When putting together an FDA practice from scratch, one might use as a model or organizing principle the statutory scheme that the FDA uses to structure itself. For example, the FDA has people who think about only drug issues and people who only work on device issues, etc. Many big law firms structure their practice in the same way, with attorneys who work on specific product categories. Other firms try and mirror what goes on in-house at a client, meaning they have someone in the practice who essentially functions as the outside-counsel counterpart to an in-house chief compliance officer, another lawyer whose job it is to serve the in-house regulatory affairs professionals, etc. Our judgment is that the best model is a portfolio approach, in which we organize ourselves around key risk areas. I describe our practice as a comprehensive and global regulatory practice situated atop three pillars: one each for global quality (GMP), global clinical trials (GCP), and US sales and marketing. In those areas, we have both deep regulatory law experience and the ability to scale up quickly because of our size and reach and the sophistication of our colleagues who have handled major matters for the leading life sciences clients across the globe. For all other regulatory issues we provide the highest quality regulatory counsel, and as new areas of risk emerge, we will adjust our model to be sure our clients’
Gail, how does your expertise within the field of genetics add value to the way Sidley structures its practice group?
GJ: My genetics and diagnostics experience is just one example of Sidley’s interdisciplinary approach to client counseling. On a personal level, the interdisciplinary approach is enriching as it allows more breadth and depth to my practice. It also adds value to our clients because we are trained to work together and to identify potential concerns beyond our own personal areas of practice. In the genetics and diagnostics space, I am able to assist my colleagues on issues and can always be mindful of other problems that may arise for a client before anyone outside of my specialty is even aware of what may lie ahead.
Last year we spoke with partner Ray Bonner about his global investigations practice. Although both of you are relatively tethered to the FDA in some degree, how often does your practice bring you overseas?
CK: FDA has reached outside of the US and now has offices in many countries. While we may be “tethered” to FDA, FDA itself has a more global reach. And, the business of our clients is global. My practice first started to reach beyond the US border when I was a junior lawyer, before I even joined the FDA Chief Counsel’s office. I had the chance to work from Europe for a year, to help my then-firm deal with a staffing crunch. Learning another regulatory law system helped me understand US law in a new way, by providing different answers to identical policy questions, or offering a completely different analytical framework. Europe and Asia are
“A key ingredient to sound regulation is frequent communication between the regulated and the regulators, which fosters and facilitates information exchange.”
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LMG LIFE SCIENCES 2013