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A Q&A with Coleen Klasmeier and Gail Javitt, Sidley Austin
Life Sciences companies face a wide range of FDA and regulatory issues that require top-tier legal counsel. LMG Life Sciences Editor Phillip Bausk chatted with Coleen Klasmeier and Gail Javitt about their approach in helping clients navigate the regulatory maze they confront on a daily basis.
What attracted you both to FDA work?
Gail Javitt: I had never heard of FDA law while I was attending law school, but I knew that I was interested in a combination of law, science, policy, and ethics. I wasn’t sure how I would merge all of these aspects. I first learned about food and drug law through writing my third year paper on preemption under the Medical Device Amendments, which courts were just beginning to address. FDA law really does have a little bit of everything; I get to interact with companies that are harnessing new genetic and other scientific discoveries to develop new therapies and diagnostics. At the same time, these new technologies require the interpretation and adaptation of statutes that are more than a century old. It is a challenge to fit novel technologies into existing paradigms; kind of like a legal Sudoku puzzle. And then there is the public health and policy aspect. FDA has such an important public health mission, and must balance protection and promotion of public health. Seemingly dry and arcane regulatory decisions implicate profound personal and societal questions involving the proper balance between individual autonomy and liberty and government intervention. Coleen Klasmeier: I was fortunate to take administrative law and statutory interpretation in law school. From that point on, I was hooked on agency law. In my third year, I had the good fortune to be recruited by a law firm that offered top-notch training in administrative law, and my first assignment was to the FDA practice. Thereafter it never occurred to me even to consider practicing in another area. Food and drug law is an intellectual feast. It in-
volves constitutional, statutory, and regulatory interpretation questions with broad implications, and the way we practice it at Sidley is unique. Our team assists the top life sciences clients in the world in all aspects of their businesses, in matters ranging from litigation and enforcement to deals to administrative proceedings to internal investigations and working on policy issues.
Coleen Klasmeier
Gail, you are well-known for your activity in the academic segment of the life sciences industry. What brought you back to “Big Law”?
GJ: I thought of it more as a choice to come to Sidley, rather than going into private practice. At Sidley, I have the chance to work with some of the leading lights in food and drug law, including Coleen, and I have the opportunity to work on some of the most interesting and challenging issues in the industry. With so many complex matters to work on from a policy perspective in both the legal and the science fields, it has been a delightful experience coming to work for a firm as entrenched in the life sciences market.
Gail Javitt
Coleen, as head of Sidley’s regulatory practice, what was it about Gail’s experience that made her an attractive addition to the team? Did Gail’s extensive genetics background play a role? If so, was it because the firm sees the genetics space as strategically important?
CK: No one can lay a finger on Gail in terms of her depth and knowledge on genet-
ics issues. She is not just a premiere regulatory lawyer on clinical diagnostics and genetic testing, but is also a superb policy analyst and a well-rounded practitioner across the full range of FDA issues. Gail was a strategic hire for us as we wanted to make sure we were ahead of the curve in the genetic testing and diagnostics space. I was persistent in my recruiting. Years ago, we had practiced together as junior lawyers and I thought it would be great to practice with her again. She understands our commitment to the highest quality standard, and in supervising and training the next generation of food and drug lawyers at
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