The 2014 Sharing Conference: PDMA, Sunshine Act, OIG and Beyond

What are the elements of a strong regulatory compliance program? How can we be sure that we are taking all the proper steps to mitigate risk? How are evolving state and federal regulations further complicating an already complicated task? Where can we go to better understand how to determine what we absolutely need to do, instead of what would be nice to do if we only had the time and the resources?

These are questions that pharmaceutical and medical-device compliance professionals consider every day, and the answers are getting more and complicated. When members of the PDMA Alliance first met in a forum of learning and sharing decades ago, compliance questions, along with a strong desire to get honest and useable answers, were the common bond that united us. We shared the challenge of addressing how the newly legislated Prescription Drug Marketing Act was impacting our individual workplaces. As we developed new policies and procedures to ensure compliance, we quickly realized there was much to be gained by the ongoing sharing of our individual situations and exchanging ideas about how we might resolve a variety of issues. We knew that we needed to discover more efficient methods of handling compliance throughout our individual companies. Even then it was clear that we could find solutions by connecting with industry colleagues, by listening to each other, and by learning from each other through the open and honest sharing of our triumphs as well as our shortcomings.

Expanding agenda

Today, those same simple acts of connecting, listening, learning and sharing are as strong an impetus as what initially brought us together 24 years ago. And at the 2014 Sharing Conference this September, we will be meeting with a similar sense of the uncertainty and trepidation due to the ongoing impact of recent legislation, a tough economy and a challenging industry.

Those who have attended previous Sharing Conferences are aware that the focus of our annual conference has expanded and broadened. While many conference participants have been singularly and successfully dealing with the challenges of PDMA legislation over the years, we know that pharmaceutical and medical device professionals involved in compliance at all levels will continue to need an in-depth understanding of the original Prescription Drug Marketing Act and its implications.

Instinctively we have appreciated the importance of the PDMA law and particularly its sample accountability mandates, and we know it must always be at the heart of our annual conference agenda. But we also know that there are many other considerations ahead. New state and federal legislation have taken their toll on our preparedness, and more and more regulations are on the horizon. And so, in the past several years, we have extended our educational interests to the complexities of Fraud and Abuse issues. We also saw the need to learn more about Investigations, OIG, Anti-Kickback, Off-label Promotions, Corporate Integrity Agreement (CIAs), and Sunshine and Transparency Reporting. Now, with the enactment and implementation of The Patient Protection and Affordable Care Act (PPACA), new challenges are impacting pharmaceutical and medical device companies as well. A few years ago, anticipating that the medical device segment would also be impacted by PPACA, we began to reach out to medical device compliance professionals who are increasingly interested in the learning and sharing our annual conference provides.

In many ways, the introduction of PPACA reminds us of the same heightened compliance challenges that were prevalent at the enactment of the PDMA. So we come together at the annual conference looking for clarity, searching for how to successfully address issues such as the Physician Payments Sunshine Act, an important part of the new healthcare legislation. Now that pharmaceutical and medical device companies are required to aggregate and report hundreds of thousands of records, the implementation of these processes is staggering. Even the smallest of errors and what may seem like the most inconsequential omission can distort the data that need reporting. The required time and effort appear to be insurmountable for many compliance professionals with shrinking staff and budgets. This transparency piece of the compliance puzzle is just one of the important issues that we plan to study and discuss among the pharmaceutical and medical device professionals and vendor partners who will gather together at our 2014 Sharing Conference this fall.

In setting the 2014 Sharing Conference agenda, the Alliance Board is planning a strategy focused on general sessions and workshops that are pertinent to today’s expanded legislation. Our guest speakers include the return of Karen Rothschild, Regulatory Counsel, FDA, Center for Drug Evaluation & Research, Office of Drug Security, Integrity & Recalls. We anticipate that Ms. Rothschild’s insights will inspire learning in many areas, including the Drug Supply Chain Security Act that is causing so much new industry buzz.

Deb Segura is the Executive Director of The PDMA Alliance

And because the Alliance Board is unanimously convinced that effective communications are essential in this challenging business environment we share, we will also hear from a communications expert—the well-known Dave Mitchell, founder of the Leadership Difference. In addition, our Town Hall event will zero in on transparency implementation, expanding on the challenges we have witnessed over the past year and what we have learned so far. Our workshop topics have also been chosen for their relevancy to new and existing challenges, including Mock Inspections, Internal Investigations, State Reporting Requirements, Governance, Oversight and Monitoring, Data Analytics and Technology, to name just a few. A visit to our website www.pdmaalliance.org will offer a complete listing and descriptions of the workshops being offered as well as an abundance of other conference information.

It is never far from my mind that the goal of the PDMA Alliance is educating our members to help ensure a safe and secure drug supply chain and to strengthen regulatory compliance programs. I am hopeful that all our 2014 Sharing Conference participants will be reenergized as Alliance members and fortified by their participation in the only industry conference that offers the best opportunity to Connect, Listen, and Learn with others who Share that common goal.

For more information about the 2014 Sharing Conference and to be added to our contact list, please send an email to [email protected].