Living Up to Our Vision

Well before the annual PDMA Sharing Conference evolved to The PDMA Alliance, many of us shared a vision that our once-a-year event would expand to year-long support for conference attendees. What we have achieved in the few short years since the inception of The PDMA Alliance in 2004 has gone beyond our expectations, with all signs pointing to our continued growth.

We quantify our growth in terms of what we have done and what we will continue to do to assist our members in addressing the breadth of PDMA-related compliance issues that challenge us. The PDMA Alliance Board understands that we represent a diverse body of pharmaceutical executives, all directly or indirectly responsible for adhering to federal and state guidelines, all charged with the mission of compliance.

Our diverse assembly also includes vendor partners, many of whom return year after year as steadfast participants. They are a unique part of the entire PDMA Sharing Conference experience, meeting with their pharmaceutical colleagues in and out of the exhibit hall, sharing insights and knowledge at general sessions, workshops and casual get-togethers. Our vendors are more than exhibitors: they are true conference participants. Beyond their informative demonstrations of the products and services they offer, their presence at the conference affords them the opportunity to gain insights into our changing needs, leading them to innovate solutions to new PDMA and other regulatory compliance challenges.

As Co-Chairs of The PDMA Sharing Conference and Alliance Board members, we have worked diligently with our Board colleagues. Our non-profit organization has been determined to offer all our pharmaceutical industry and vendor partner conference attendees (our PDMA Alliance members) more than what is available from any other conference related to PDMA compliance. What makes us the premier conference event is exemplified by free membership advantages to The PDMA Alliance that begin with conference registration and extend one year beyond the conference.

The Members Only section of The Alliance website serves as a 24/7 connection to the ongoing information that we share. This policy proves itself in the number of participants who return year after year for the conference experience as well as for the use of Members Only as a daily resource.

A real connection with The PDMA Alliance Board is something that all of our members can count on. An important section of the website invites members to “Interact with The Alliance.” It’s the place to pose questions and get answers. Members appreciate that we truly listen to their recommendations, recognizing that we all stand together as the voice of pharmaceutical compliance professionals. In that respect, there is no other organization like us: we are exclusively and fully dedicated to adhering to the full intent of the PDMA, encompassing in purpose and in action the depth of what it means to be PDMA-compliant.

Professional relationship with government

The PDMA Alliance is distinguished by our ability to interface with government agencies so that we are well informed about new, existing and proposed federal and state legislation that may have an impact on compliance efforts. An example of this relationship can be found in the FDA Incident Reporting System, a standardized tool initiated by The Alliance that allows pharmaceutical companies to easily and electronically submit reports to the FDA. A good number of our members use this tool at their companies. The Alliance also provides pertinent FDA communications to our membership and has been doing so over the past several years.

Channeling the flow of information

Disseminating valuable information to our members on a timely basis is most important to us and we have been able to provide a steady stream of bulletins to our pharmaceutical executives with involvement in PDMA compliance. Alliance members are intensely interested in state laws that require drug manufacturers to adapt compliance programs and/or codes of conduct related to payments made to healthcare professionals. That’s why our membership was alerted to proposed new rules set forth in New York, New Jersey, Massachusetts and Vermont early on. We presented the facts about disclosure mandates focusing on the deadlines, fees and processes associated with the reporting of specific information about gifts and expenditures.

Ethical guidelines and reporting

The PDMA Alliance has also been active in reviewing guidelines set forth by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Assn. (AdvaMed). These guidelines consist of recommendations for voluntary codes of ethics regarding pharmaceutical companies’ interactions with physicians. Recommendations such as these are significant in light of the Patient Protection and Affordable Care Act, the new healthcare reform legislation that was signed into law in March. An amendment in the new federal law addresses the imposition of new reporting requirements for pharmaceutical manufacturers and their distribution of drug samples. The full impact of this legislation is something that The PDMA Alliance is looking at through the educated eyes of specialists in how the new legislation will affect pharmaceutical companies. Our membership can certainly expect more information in addressing the impact of this legislation as the months go by.

Webinar: A tool that links us together

In 2009, we held our first webinar, “Emerging Regulations in the District of Columbia and Massachusetts,” a major accomplishment in bringing our members together separate from our annual conference. On our website, there’s a place to retrieve copies of the presentations for members only as a benefit to those whose schedules did not allow them to participate in real time and also for members who may join The Alliance after an event has taken place. Earlier this year, we held our second webinar, “How the New Healthcare Reform Law and Sunshine Act Provisions Affect Aggregate Spend, Drug Samples and Transparency.” The enthusiastic response to these webinars leads us to planning more educational online assemblies, free for our members, in the future.

Sharing our enthusiasm

We are continually impressed with the enthusiasm and energy of our PDMA Alliance colleagues - those with whom we serve as Board members, the general membership, and the friendly and wise professionals that we have met at past conferences and look forward to meeting in San Diego in October. Their creativity never fails to astound us, as they dedicate themselves to ensuring the nation’s safe drug supply while staying in compliance within a profitable business environment. In looking at the accomplishments of The PDMA Alliance over the years, it is satisfying to see that our hard work has enabled us to reach many of our objectives. But make no mistake about it, rather than rest on our laurels, we are accepting the challenge of what’s in store for our industry in the days ahead.

For those who are planning to attend The 2010 PDMA Sharing Conference in October, there’s the assurance that amidst our serious considerations, there are some relaxing, comfortable events to share. Our 20th Anniversary theme, The Power of Sharing, applies to what we can achieve when we band together — a stronger, collective voice within the pharmaceutical community that is ready to address important issues that affect us all. Beyond the time we share during the conference in the beautiful setting of The Hilton San Diego Bayfront, we can also look forward to continuous learning through ongoing educational opportunities that will be made available all year long to members of The PDMA Alliance. PC

About the Authors

Tina A. Posey is Associate Director, Sample Compliance, Office of Ethics & Compliance, Takeda Pharmaceuticals North America, Inc., and serves as PDMA Alliance Secretary. Rafael Gonzalez is Senior Manager, Samples and Promotional Materials Management, King Pharmaceuticals, Inc., and serves as PDMA Alliance Vice President.

For more information about The PDMA Sharing Conference and for details on how you can become an Alliance member, please contact us at [email protected]