We spoke to Jennifer A. Romanski, JD, Vice President, Porzio Life Sciences and Sara R. Simon, JD, Compliance Associate, Porzio Life Sciences, about their motivations for helping clients, what interesting legislation is coming related to State Price Transparency and more.
What is your motivation for helping your clients?
Jen: “We really try to familiarize ourselves with the business and key stakeholders and understand the commercial objectives of the company from the start of the relationship. We take to heart the fact that compliance is not one size fits all. I think it is such a privilege to serve the life sciences industry, and the last year has shown the importance of the industry and how it benefits society in more ways than we can imagine. We continue to be motivated by our clients and their objectives – we learn from them on a daily basis. We never forget that we are a part of the industry that is helping to save lives and making lives better for patients.”
Sara: “I truly believe the pharmaceutical industry overall is operating with the right intentions, but unfortunately, the industry has developed a bad reputation in the eyes of the public. I am motivated by the idea that we can help companies strike a balance between the (sometimes) competing interests of profitability, compliance with all of the federal and state laws that affect companies today and affecting the lives of patients for the better by providing affordable and accessible treatment options. At the end of the day, no one wants to see the pharmaceutical companies struggle because they were penalized for not doing the right thing, even inadvertently. This idea always seems to motivate me in my work, particularly in the state price transparency space.”
What do you do on a day-to-day basis?
Jen: “I’m grateful that the regulatory and compliance counseling that I do enables me to interact with clients daily on all sorts of questions. I speak to clients ranging from small to large pharma, med device, and biotech companies every day. Some are more focused on regulatory issues like advertising and promotion or sample compliance, while others are more focused on legal risks, like engagements with HCPs and considerations related to anti-kickback, false claims, and anti-bribery issues. Many of these questions are related to operationalizing the compliance function, so helping to right-size compliance for the size of the company and lifecycles of the products involved is something I handle daily.”
In your opinion what is the most interesting legislation already in place or potentially coming down the line that will affect your clients and how can you assist them?
Sara: “There are so many to choose from, but to me, it is interesting seeing what's coming next in the area of state price transparency. This will be the focus of our session at the Drug Pricing conference in November. Many states have already implemented laws and there is a lot of proposed legislation in this area too. Every time I see a new state propose legislation I immediately try to understand how it may be similar to other states, and how it differs; there is always something interesting behind a state's motivation to control prescription drug costs and how each state operationalizes that process, once a bill becomes law. There is also proposed federal law which could be a real game-changer in terms of reporting obligations.”
What do you feel is the most exciting service or product you provide to clients and why?
Jen: “Obviously, I am very excited about our newer products – Porzio Third Party Engagement and Porzio GST®. Both are state-of-the-art products that have really been carefully considered in development to address the most current compliance and regulatory obligations of life sciences companies. I'm always excited to talk about them and get a better understanding of what clients need and how these products can help them.
Of course, as someone who has been with Porzio Life Sciences® since we launched in 2004, I have always had a great sense of pride in some of our older products, like Porzio Compliance Digest®, which is constantly evolving and has been the cornerstone of our suite of products and services. It aligns with our mantra of being "built from the law" and PCD is an efficient way for compliance, legal, and regulatory professionals, among others, to keep up with the changing regulatory landscape. In fact, as a practicing attorney, I utilize PCD on a daily basis to help address legal and compliance questions for my clients.”
Share a shameless plug: Join Jennifer and Sara on September 15th for a live webinar – "State Drug Price Transparency Laws: Anticipating Reporting Responsibilities and Making Sure Your Company Is Prepared." This will serve as a refresher and overview on the topic ahead of their session at Drug Pricing in November. Join Jennifer and Sara by registering for the webinar here.
Just for fun…What profession other than your own have you always wanted to attempt and why?
Jen: “I have always thought about teaching kids, probably middle school level. I have teens of my own, and (pre-Covid) volunteered at the school whenever I was able. I have always appreciated the sense of promise I felt by interacting with the youth. I feel that we can learn a lot from fresh, creative minds and I always thought if I had the opportunity to teach not only could I help open their minds, but I could learn quite a bit from them.”
What is your favorite city for business travel and why?
Sara: “I love traveling to DC for business travel. I’m intrigued by government and the entire political process. I was attending a conference in 2012 on the night of Obama’s reelection and will never forget the excitement in the streets, both people and cars, when it was announced that he had been re-elected for a second term. It was very exciting to be in the heart of such a consequential and historical event.”