January 08, 2019

Law360 features QA with Claudia Lewis on the FDA

On January 8, 2019, Claudia Lewis was featured in a Q&A exchange in Law360 on her take on the FDA, noting that she is eagerly awaiting an FDA definition of “natural,” chafing at new limits on homeopathic products, and anticipating a nationwide policy on cannabidiol (CBD). Here is an excerpt:

Q: What's an important skill for an FDA lawyer — aside from a background in science — that they don't teach in law school?

Lewis: An important skill that takes time to learn is how to balance the regulations with client goals. Most of our clients have a general understanding of the basic rules, so they don't need to call Venable for the black letter of the law. Our job is understanding how they can reach their goals while managing risk.

A lot of my clients, if you were to talk to them, know that I say this all the time: “If you do everything I say, you won’t make any money.” And so it's risk management in terms of being in alignment with the law.

Obviously, we don't counsel clients to color outside the rules. But what is it you really need to do? Should you be in a different category in order to meet your goals and not have such an onerous regulatory burden? Should you modify your claims in some way? What is it that we need to do to make sure you’re in compliance but also meeting your business goals? And I think threading that needle is not something that is really talked about in law school.

Q: What do you look for when hiring an FDA lawyer?

Lewis: When I’m looking to hire a lateral, I want to make sure the person is learned in the FDA space and they're creative, because sometimes the law is not black and white, and honestly no one would need a lawyer if the rules were clear. So part of being in the regulatory space means that we need to be flexible and creative.