Lauren Roth is the Assistant General Counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association that represents the country’s leading biopharmaceutical researchers and biotechnology companies. PhRMA’s mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical and biotechnology research companies. Lauren is also an alumna of Sidley’s Washington, D.C. office. Kristin Graham Koehler recently sat down with Lauren to catch up on her current role and the trends she is seeing in the pharmaceutical industry.
Tell me about your current work at PhRMA.
Lauren: My job is policy-oriented; I don’t counsel any individual member company. I work on enforcement issues involving the Department of Health and Human Services Office of Inspector General (HHS OIG) and Department of Justice (DOJ). For example, when the OIG issues a guidance document or seeks comments on how it should exercise its enforcement discretion, PhRMA provides input from the industry perspective – an industry that has been under close scrutiny by the OIG for nearly the last 15 years. There is also a component of Hill advocacy in my work. I don’t typically do the direct advocacy on the Hill, but I provide legal support to PhRMA’s federal team.
What do you like most about your job?
Lauren: I see the big picture more – both because I’m working on policy issues and because I have more exposure to more companies. In private practice at Sidley, when I worked on investigations, I would get the opportunity to dig deep on one matter with one company. Now, I work on more discrete projects that involve a wide range of companies, so I have an opportunity to see what their issues are – the changing business models, the products that they are selling, their history of being subject to enforcement actions, and how they react differently to a single guidance document or problem.
Is there any advice you would give to lawyers working in a firm?
Lauren: Yes, three things: One, be proactive. Don’t sit and wait for work. Two, be precise. One of most luxurious things of working at a firm is the ability to take time to be precise and clients expect that level of effort and attention to detail – it will make you more valuable to your team and more trusted as a colleague. Three, be a really good team member. You will get better work if you have a better attitude about the work.
What about advice for associates that are thinking of transitioning to an in-house position?
Lauren: In-house, things are much more fast-paced. At the firm, there may have been a lot of little projects going on, but they typically related to one case. Now, I have a lot of clients, and they all want answers right away and their questions are all on different topics. You have to be prepared to think on your feet, and do any necessary prep work at the beginning or end of day. During the middle of the day, you’re going to have to change your hat a lot and be very nimble.
What trends are you seeing in the pharma industry?
Lauren: The biggest one is how to deal with customers in the paradigmatic shift from a fee-for-service payment methodology to value- and outcomes-based methodologies. The current Administration has actually set quotas for moving to alternative payment models in the coming decade. Many pharma companies are undergoing large modifications of their business models as a result of these trends. From my perspective, companies and the OIG are going to have to get their arms around what that means from a fraud and abuse perspective because the old paradigm of what constituted a potential violation of the anti-kickback statutes may not apply. It’s going to take a lot of time to work that out.
Published June 2015 - UPDATE Senior Advisor to the Chief of Staff, FDA (October 2017 – Present)
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