PDMA Alliance: Change is the new norm

Since our first meeting 23 years ago, the annual PDMA Sharing Conference has focused on one crucial area: addressing and responding to the changing aspects of pharmaceutical compliance. With most legislative acts, the implementation of the law initiates unforeseen challenges to compliance, leading to unpredictable consequences that might be avoided through more careful scrutiny. This comes as no surprise to industries affected by legislation. We have all become accustomed to emerging nuances and subtleties of federal and state regulations as legislation goes through the process of implementation.

When The Alliance Board came together in January to begin to develop the content for this year’s Sharing Conference, it soon became clear that the roadmap that compliance professionals are following is in the midst of great change. In the early days, our Sharing Conference was dedicated to gaining a better understanding of The Prescription Drug Marketing Act (PDMA), which required close scrutiny of sample accountability policies and procedures. Over the past few years we have experienced many more detours on the road to compliance, and we have incorporated issues such as fraud and abuse, aggregate spend, and OIG Guidance into our learning.

Today, the landscape is even more crowded with signs of compliance that need to be addressed. Data Integrity, Corporate Integrity Agreements, the Sunshine Act, the Patient Protection and Affordable Care Act and a myriad of new and often contradictory federal and state laws are all sending compliance professionals in different directions. In planning our theme for this year’s conference, we recognized how intensely the traffic was building on the road to compliance. The signs of compliance that we need to adhere to are turning up faster than we anticipated, and as an organization of subject matter experts, The Alliance needs to provide direction for all of them.

For Alliance members, there is an undisputed, ongoing desire to expand our perspectives, share our concerns and to learn from those who are particularly skilled at interpreting the laws. Our objective is to bring together those who can identify the implications that may elude us. Changing the way we think, changing our approach, changing old methods in favor of new ones, and changing our uncertainty to positive actions are all part of the new norm.

The 2013 Sharing Conference, which will be held from Sept. 29th to Oct. 2nd at the Baltimore Marriott Waterfront, remains the industry’s best opportunity to gather the expertise required to address the changing signs of compliance. It is the annual meeting where attendees will find information and learning opportunities related to the most current compliance topics, presented by subject matter experts from the federal and state government, the life sciences industry and the vendor community.

Our attendees represent professionals from pharmaceutical and medical device companies who are involved in all aspects of compliance from regulatory to sample accountability, security, sales operations, analytics, ethics, investigations, audits, sales force automation, quality assurance, risk and transparency, monitoring, and training. They come together for the unique combination of learning, sharing and networking that the Sharing Conference is known for. And with conference registration, our attendees also receive membership in The PDMA Alliance, the year-round organization that puts together this well-respected and eagerly-anticipated annual conference for life science professionals.

This year, as in previous years, we are engaging guest speakers who know and understand the current climate of compliance, experts who keep pace with the dynamic aspects of legislation.

FDA, CMS, Vermont

We’ve had the good fortune that some of our speakers agree to return to our meeting. Specifically, I am very happy to say that we’ll hear from Karen Rothschild once again. As Regulatory Counsel of FDA’s Center for Drug Evaluation & Research, Office of Drug Security, Integrity & Recalls, Ms. Rothschild is the authority we most want to hear from regarding regulations that deal with OTC and prescription drugs, including biological therapeutics and generic drugs. Ms. Rothschild’s return is a good example of how so many aspects of compliance experience ongoing change and reinterpretations.

I am also very pleased that our agenda features Kate Whelley McCabe, assistant attorney general, public protection division, Vermont Office of the Attorney General. Since 2009, Ms. McCabe has been Vermont’s Assistant Attorney General, where she has worked in the civil litigation and public protection divisions. Her background includes the implementation and enforcement of the state’s Prescribed Product Gift Ban and Disclosure Law, a topic of great interest to Alliance members.

As this article went to press, we received word that a representative of the Centers for Medicare and Medicaid Services (CMS) will be taking part in our conference. Toula Bellios, acting director of the Division of Policy & External Partnership, data sharing and partnership group in the Center for Program Integrity is tentatively scheduled to be part of a general session. We are currently in the planning stages of a panel discussion on Open Payments (Section 6002 of the Affordable Care Act) featuring Ms. Bellios and others.

The Alliance has also engaged Jeff Mackie, PhD, a well-known and highly respected humorist, to share his wit and wisdom with us. He brings his past experience as a primary motivating force in the sales and marketing team of a top pharmaceutical company, along with his gift for encouraging audiences to see themselves in a new light. We know that Dr. Mackie will challenge and inspire conference participants.

Sharing Conference attendees who have been with us before know the high quality and value of our presenters. In the past, we have been honored by the participation of elected and appointed government officials, FDA and CDER and other regulatory counsels, attorney generals and their assistants, law enforcement professionals, investigative professionals and pharma executives with vast experience as corporate compliance officers. These experts are always willing to share their knowledge and experiences with us. They generously enlighten us with perspectives that are different from those of the average pharmaceutical executive. They provide valuable information about monitoring our compliance efforts to avoiding violations. They advise us about how to handle investigations. We have even heard from a wayward pharma sales rep who gave us a good look into how to identify behavior that circumvents compliance. In every way, what our speakers share with us influences and enhances the way we and our companies are staying compliant.

Vendor expertise

Because we are an organization that values sharing, we consider our vendor partners to be a vital component of our organization. We include vendor representatives on our Board and we are very happy to have an outstanding vendor team in place this year: Judy Fox of Compliance Implementation Services, Jim Oppold of Triplefin, Ray Ungemach of MedPro Systems and Jeff Wojcik of TGaS Advisors. We value their insights and expertise, both in the development of our conference and in our regular communications with Alliance members. One of our objectives continues to be providing news and valuable insights on compliance issues on a year-round basis, not just during the annual Sharing Conference. The expertise of all our Board members plays a significant role in our ability to deliver these insights and I am very appreciative of their dedication to The Alliance.

In recent years we have also benefitted from the increased participation of our conference sponsors, some of whom have signed on to offer their expertise at workshops. Their presentations bring additional educational value by contributing new learning opportunities from the vendor perspective, the people who are innovating products and services that support compliance. These valuable vendor contributors are called on to follow the same signs of compliance that highlight our 2013 Sharing Conference journey.

The Alliance is building a legacy of transparency through an assembly of life science professionals who share the goal to protect our nation’s drug supply for the health and well-being of consumers across the land. Their honesty about the real challenges of compliance, and their successes and struggles in meeting those challenges, are all valuable lessons to be learned. We accept change as the new norm in 2013, replacing the fear of uncertainty, and paving the way for a better understanding of the challenging signs of compliance.

Advantage Management Solutions

Booth #208

Customer data management services and regulatory compliance; proactive compliance support.

www.AdvantageMS.com

Health Market Science

Booth #301

Comprehensive provider databases including healthcare providers (HCPs,) healthcare organizations (HCOs,) and their affiliations, coupled with the largest medical claims database in the U.S.; compliance and analytics of these databases.

www.HealthMarketScience.com

Porzio Life Sciences

Booth #105

Regulatory compliance services, including PDMA, anti-kickback statutes, False Claims Act, FDA, OIG, Physician Payments Sunshine Act and state aggregate spend compliance regulations.

www.PorzioLifeSciences.com

Sysdyne

Booth #103

Sample accountability management, forecasting, reconciliation, process management and process analytics.

www.Sysdyne-inc.com

Compliance Implementation Services

Booth #214

Regulatory compliance strategies for GxP Compliance, Commercial Compliance, Commercial & Federal Contracting and Government Programs.

www.CIS-Partners.com

Howell Marketing Services

Booth #101

VAWD-accredited drug fulfillment and distribution; literature fulfillment; kitting and assembly; direct mail.

www.HowellMarketingServices.com

Priority Solutions International

Booth #212

Sample fulfillment and distribution; inventory management.

www.PrioritySolutions.com

TGaS Advisors

Booth #204

Consulting and advisory services on commercial operations.

www.TGaS.com

G&M Health

Booth #201

G&M Health is a health and life-science service company offering compliance management services, computer validation, project management, audits & assessments, training and regulatory support services.

www.GMHllc.com

J. Knipper & Co.

Booth #200/202

Sample management and accountability systems; multi-channel marketing; AMA database services.

www.Knipper.com

QPharma

Booth #211

Regulatory compliance and brand support, including aggregate-spend reporting, sample accountability, fulfillment; professional services in IT validation and project management.

www.QPharmacorp.com

Triplefin

Booth #300

Hub services including patient assistance, reimbursement solutions and patient adherence solutions for pharmaceutical brands.

www.Triplefin.com

Genesis Logistics

Booth #205

Genesis Logistics specializes in providing compliant customized logistics services to pharmaceutical companies that ship sample prescription drugs to field sales representatives.

www.GenesisLogistics.com

MedPro Systems LLC

Booth # 100/102/104

Healthcare licensing data services; IT-based licensing data management.

www.MedProSystems.com

RGIS

Booth #209

RGIS is a leader in healthcare inventory management services including: Sample accountability and audits; fleet inspections, pharmaceutical/hospital inventories, PDMA compliance and medical device audits.

www.RGIS.com

Uncle Bob’s Self Storage Business Alliance

Booth #203

Uncle Bob’s, with facilities in 25 states, brings consolidated invoicing, rental processing, facility locating, and technology that gives pharmaceutical companies visibility and control over the process.

www.Sovranss.com