Scott Liebman and Elizabeth Kim work closely with their clients in the life sciences industry to bring new products to market and address the range of regulatory compliance issues involved in commercializing pharmaceutical and medical device products, all while always keeping in mind the client’s bottom line. Liebman is Chair of Loeb & Loeb’s FDA Regulatory & Compliance team and Co-Chair of the Life Sciences group, and Kim is a partner in the FDA group who also has experience being seconded to clients as a compliance officer and assistant general counsel. Their combined experience means they bring a business-minded approach to their practice and serve as trusted advisers to their clients. Given their vantage point, we wanted to get their take on regulatory and compliance trends in the pharmaceutical industry.
Lawdragon: There seems to be a tension these days in the pharmaceutical industry, with seemingly less enforcement on the one hand but increased public scrutiny on the other. How is this affecting the industry landscape?
Elizabeth Kim: This is an issue of perception vs. reality. FDA is continuing to enforce many of its same priorities, including the opioid crisis, use of social media and prescription drug promotion. Meanwhile, the Department of Justice continues to make anti-kickback violations in the industry one of its top priorities.
LD: What sort of effect do you think Scott Gottlieb’s departure from the FDA will have on the policies he was most focused on, such as the opioid crisis?
Scott Liebman: Gottlieb focused on issues such as the opioid crisis, youth vaping and tobacco use. These issues are still ongoing, if not receiving more attention than ever. The baton has been passed and opioid addiction has remained one of the FDA’s highest priorities.
Gottlieb’s immediate successor, Norman Sharpless, worked to continue Gottlieb’s initiatives on youth vaping and the opioid epidemic and it appears that the new Acting Commissioner, Brett Giroir, will do the same.
We will being paying close attention to the confirmation process for President Trump’s nominee, Dr. Stephen Hahn, to learn more about his vision and priorities for the agency, but both the opioid crisis and vaping will almost certainly remain hot topics and priorities for the FDA for the time being.
LD: Can you speak to the current enforcement landscape for pharma advertising, particularly as these companies move into more social media and digital ads?
SL: We’re still looking for greater clarity on off-label issues and what qualifies as information that is consistent versus inconsistent, particularly for patient-facing materials.
Social media is continuing to be an issue for life science manufacturers. Social media is such a big part of American culture, but the regulatory framework makes it difficult for these companies to communicate effectively using these outlets. Following an initial hesitation based on FDA guidance documents, we are now seeing a shift to more branded social media.
LD: The pricing of drugs has received a lot of public scrutiny in recent years. Can you speak to the trends there, both on the regulatory and manufacturing sides?
SL: This is a very complicated issue and there are a lot of factors to consider in communicating this information to patients and providers. The information has to be presented in a standardized and meaningful way. The FDA has very little jurisdiction in this area. If there’s going to be a change, it may need to come from Congress. We have already seen states such as Colorado take this issue into their own hands and pass legislation on the disclosure of drug pricing in promotional materials. We’ve had many clients come to us with questions on how to comply with Colorado law. Unfortunately, there hasn’t been any further guidance from the state beyond the initial regulation.
LD: You both work closely with clients, often at the core of their companies with product launches and compliance. What are some of the challenges or advantages of working with clients on issues so central to their businesses?
EK: When you work as closely with clients as we do you are really in the trenches with them. This is really unique to our practice. Understanding how to operationalize for each client is challenging. We don’t work in a vacuum, but work alongside the business to find compliant and creative solutions to our client’s problems.
SL: It’s important to find pragmatic solutions to our client’s issues. The regulatory framework is not always set up for how our clients operate. Our job is to find a way to meet their business objective, while mitigating risk. Typically, lawyers are brought in when there is a problem. For us, we get to help companies throughout the development of their products and guide them through launch. This is a really exciting time for a life sciences company because they often spend years bringing their products to market. We have an innovative, exciting client base and that energy flows through all of our work.
LD: What are some of the challenges of advising clients amidst ongoing policy shifts?
SL: Many of our clients are large, global manufacturing firms with sophisticated policies. This makes it challenging to implement large-scale changes as policy shifts. We have seen this as privacy becomes a bigger issue with different regulatory schemes in the US and GDPR in the EU.
LD: How does the firm’s compliance practice successfully work across various disciplines?
EK: We offer our clients service on the full spectrum of legal and compliance issues related to their business. This requires us to work closely across disciplines and collaborate with those in other practice groups. On a daily basis we work with various teams, from Intellectual Property to Corporate & Capital Markets to Investigations & Compliance.
SL: Our large and diverse Life Sciences team, including regulatory specialists, industry veterans, and lawyers with advanced scientific degrees, allows us to offer our clients a full-service experience and interdisciplinary solutions. We practice in areas as diverse as litigation, privacy and data security and advertising and promotions. We also pride ourselves on being a global team, working with businesses of all sizes around the world.
LD: What first drew you to working in compliance for the life sciences industry?
SL: It was a natural fit. When I was coming out of law school in the early 2000s, the industry was growing quickly and was a fun and dynamic area to work in. There was a convergence of an innovative industry layered with a changing regulatory framework, along with a shift towards biologics and precision medicines. The most exciting part of doing what I do is helping clients launch a new drug or innovate a new diagnostic that has never existed before that changes the landscape of healthcare for the rest of human history.
LD: What do you see as the next big trend in life sciences regulation?
EK: Clinical trials are a big area of focus. Additionally, I see the regulation of cosmetics becoming a big trend, especially with more and more products being made in China. This is where our global experience will allow us to provide our clients with advice on navigating these new challenges.