SKILLS FOR SUCCESS
March/April 2008
Career Booster or Bomb
Regulatory Savvy: Secret Weapon for Healthcare
Ilyssa Levins, President, HCIL Consulting and the Center for Communication Compliance
With the healthcare industry hyper-focused on compliance, regulatory savvy can be a career booster or it can create a career bomb… given that the consequences of noncompliance include criminal prosecution, negative media attention and permanently damaged reputations. And no one wants their 15 minutes of fame from earning the company a warning letter or worse.
Clearly, regulatory know-how is not just for regulatory professionals anymore; it can make or break careers in any segment of the industry. One of the workshops at the HBA’s 2007 Leadership Conference addressed the link between careers and regulatory compliance. I had the privilege of running that session with Wayne Pines, President of regulatory services and healthcare at APCO Worldwide, and Liz Kay, who leads Cramer. The workshop was sponsored by Saint Joseph’s University (Philadelphia), which offers accredited executive pharmaceutical marketing MBA programs exclusively focused on the pharma industry.
Everyone agrees that patients and the general public need as much information as possible about their health and treatment options. In fact, the Institute of Medicine calls this demand for information patient centered care and considers it one of the six essential components of high-quality medical care. The Institute’s definition: “Healthcare that establishes a partnership among practitioners, patients, and their families to ensure that decisions respect patients’ wants, needs, and preferences and that patients have the education and support they need to make decisions and participate in their own care.”
The benefits of this approach include: Superior clinical outcomes; higher consumer satisfaction; improved access to needed care; reduction of inappropriate use of treatments and services; lower healthcare costs; and trust in the patient-industry relationship.
Says Kay: “There is a multitude of channels for getting information on marketed treatment options to patients, caregivers and the general public. But at the same time, companies cannot promote drugs outside their label or to patients that don’t need them.” And, according to Pines, there are two key questions that must be asked when designing or executing any communications program: “First, are my actions really intended to ensure that those who will benefit from the drug are the intended audience? Second, am I presenting this audience with all the information they need to make an informed decision, because every product has risks?”
Cultivating regulatory savvy is a road that needs to be walked throughout a career in the industry. “The healthcare industry is highly regulated and, given the rapidly changing environment, interpreting, complying with and monitoring the regulatory changes prepares those who are in the industry to do their jobs better,” says Prof. Thani Jambulingam, Chair of the Pharmaceutical Marketing Department at Saint Joseph’s University. Paying particular attention to some key signposts can help professionals navigate the tricky terrain.
The following five Rs will help guide promotion in a regulated environment.
#1: Recognition. Understand the terrain so you are perceived as being on the ball. Th is means establishing a knowledgeable foundation for planning and execution, including reading the three documents that essentially guide everything we do when it comes to communications: The PhRMA Marketing Code, which governs the industry’s relationships with physicians and other healthcare professionals; the Office of Inspector General (OIG) compliance guidelines, which sets forth the tenets of a program that pharmaceutical companies should follow to be in compliance; and the ACCME Guidelines, which issued guidelines defining what could be considered independent support for continuing medical education programs.
#2: Responsibility. Every company has its own culture of compliance. It’s critical for senior management to let everyone in the organization as well as vendors and all other stakeholders understand the company’s risk tolerance and that compliance is central to how the company functions. But the reverse also is true: Vendors should clearly understand what is expected of them by their clients and have their own compliance culture.
#3: Retention. On the job satisfaction increases when teams at all levels feel their employers support education. This includes sponsoring attendance at professional meetings such as the Drug Information Association’s annual marketing session on advertising and promotion and distributing relevant articles.
#4: Relationships. Agendas should be aligned with legal and regulatory. Start initiatives with alignment meetings to en-sure shared vision of compliance, between Marketing, Medical Affairs, Product PR, Corporate Public Relations, Sales, DTP, Advocacy/Alliances, Legal and Regulatory.
#5: Reflection. Our industry is delivering so much to the public health and our end goal is always ethical, high-quality patient care. The environment is only going to get more intense with scrutiny more severe. Regulatory savvy is an ongoing commitment. In the end, we owe it to ourselves, our associates and our organizations to deliver on this goal within an ever more restricted regulatory environment.