New Healthcare Compliance Manual - A Conversation with Simone Handler-Hutchinson '93
Associate Dean Kathleen Boozang and Simone Handler-Hutchinson ’93 (pictured, left), Executive Director of the Seton Hall Law Center for Health & Pharmaceutical Law & Policy, co-edited the first edition of the Pharmaceutical and Medical Device Compliance Manual, in conjunction with the American Health Lawyers Association and Food and Drug Law Institute. Handler-Hutchinson explains, “We designed this guide to help professionals both decipher the intricate web of laws and the practices of regulatory and enforcement authorities within the health and life sciences arena, and give them the knowledge and skills they need to implement an effective compliance program.”
After 15 year of legal practice in the healthcare field, Handler-Hutchinson joined the Seton Hall Law Center for Health & Pharmaceutical Law & Policy in 2007 to spearhead the Healthcare Compliance Certification Program (HCCP), a four-day executive training originally developed in collaboration with Johnson & Johnson. Launched in 2004, the HCCP was designed to provide legal and compliance professionals within life sciences organizations – pharmaceutical, medical device, biotech and others – with a strong foundational knowledge of the laws, regulations and industry guidelines governing the life sciences industry.
The HCCP curriculum focuses on a number of key risk areas for life sciences firms, among them the FDA laws and regulations governing the development, approval, marketing and sale of drugs and devices, the federal False Claims Act, the Anti-Kickback Act and the Foreign Corrupt Practices Act (FCPA). These laws have been the source of numerous enforcement actions against life sciences companies by U.S. agencies, resulting in multi-year settlement agreements, civil and criminal penalties, and significant fines - in some cases exceeding $1 billion. The FCPA is one example of a law that directly impacts how life sciences firms operate around the world. While the FCPA is a U.S. anti-corruption law, it can nonetheless be applied extra-territorially to business conduct that takes place around the globe. Companies are therefore tasked with implementing effective compliance policies and procedures that address FCPA risks in each country in which they do business.
Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy has gained global prominence as a leader in compliance expertise and training. Meanwhile, there is a sea change within the industry as more life sciences companies adopt a culture of compliance worldwide, resulting in an increasing need for training and understanding. In fact, HCCP participants urged Seton Hall Law to expand the program globally for their non-U.S. partners and colleagues. The Center now hosts trainings in Paris that focus on European law, and in Singapore that focus on Asian-Pacific law. Handler-Hutchinson oversees the global programs, and Sara Simon ’94 joined the team to focus on the U.S. trainings specifically.
Dean Boozang (pictured, left) serves on the Board of the American Health Lawyers Association and saw the development of the Pharmaceutical and Medical Device Compliance Manual as a natural extension of the original HCCP, and consonant with the Law School’s teaching mission. She and Handler-Hutchinson recruited authors from among the HCCP faculty across the spectrum of in-house compliance, legal counsel and government enforcement. Handler-Hutchinson says, “Each chapter was written by a leading regulatory official, a practicing attorney, or a healthcare consultant who has either shaped the policies as an official, or as counsel in the nation’s regulatory agencies. Several have advised on, or actually built compliance functions within life science corporations. They have first-hand experience and knowledge and they offer practical and actionable advice.”
Handler-Hutchinson is gratified when she hears from former HCCP alumni, many of whom have advanced within their compliance organization, some to the role of chief compliance officer. She says, “More and more, I hear that people are addressing compliance issues proactively when a healthcare product or service is first being developed or marketed. One compliance officer noted a significant culture change within his organization over the past 10 years – when he used to visit business units, his colleagues would literally close the door as he approached. Today, they flood him with questions and view him as a resource and business partner. It’s become clear to me that today’s compliance professionals are highly valued, dedicated, and they want to do the right thing. With training and guidance, they can lead the way for their organizations.”