Life sciences compliance professionals representing 175 companies recently came to Washington, D.C., for the 2018 CBI Pharmaceutical Compliance Congress (PCC). Jim Massey, global vice president of sustainability engagement and strategy at AstraZeneca, helped kick off the conference with a familiar theme in healthcare: change. Massey pointed to “megatrends” at the political, social, organizational, and individual levels that have radically impacted life sciences companies. Increased connectivity, for example, has led to previously unimaginable power of the individual patient’s voice — influencing everything from patient access and pricing scrutiny to patient-focused drug development.

Just as the healthcare landscape is evolving, so too are the expectations of company compliance departments — both internally in the business and from external stakeholders. People are looking to organizations to provide ethical leadership, Massey said, and compliance is on the front lines.

Earning (and Keeping) a Seat at the Table with the Business

Compliance leaders at the conference stressed that the compliance function should no longer be solely focused on monitoring and controls, but on being trusted advisors to the business. Compliance professionals need to immerse themselves in their organization, engage early on to understand their business partners’ needs, and help guide the business to achieve goals in a compliant and ethical manner.

Useful advice for earning (and keeping) a seat at the table and demonstrating value included:

• Involving the business in the risk assessment process: The exercise of having senior leaders think about assessing and mitigating risk helps connect compliance activity to the needs of the business.
• Keeping your compliance program “fresh” by staying up-to-date on enforcement trends and using cutting edge tools to support your efforts: This includes monitoring internal data sources such as emails/text messages/company-sponsored social media, as well as large external data sources, such as Open Payments and Medicare Part D data.
• Documenting changes in behavior resulting from trainings, enhanced controls, or other meaningful compliance activity: Utilize trending of key data points to clearly and effectively show “before” and “after” behavior of the business to demonstrate effectiveness.
• Benchmarking is helpful — when tailored to the business’s unique needs and risk profile: The government recognizes that effective compliance does not rely on a one-size-fits-all approach, and the business will value thoughtful tailoring of the compliance program to the issues at hand.
• Understanding and communicating the “why” behind compliance controls: Sophisticated business stakeholders now see compliance as a partner. Compliance leaders at the conference acknowledged that sometimes you’ll have to “lean in” on particular requests, but that having frequent and open conversations about the risks that resonate with the business will position you as a trusted advisor.

Keeping Up with Enforcement Trends and Government Expectations

In addition to providing a forum for fellow compliance professionals to share learnings, the PCC gave attendees an opportunity to hear government representatives discuss enforcement trends and compliance expectations. Valuable insights from the government panels include:

• Orphan and specialty drug consideration: The government continues to home in on sales and marketing activity that broadens the population base for drugs approved for patients with rare diseases. The Food and Drug Administration highlighted recent off-label settlements by Celgene and Aegerion to drive home this continued attention.
• A focus on smaller companies and startups: Prosecutors are now eyeing smaller companies and those funded by venture capital — where spending money on compliance may not be a priority by executives focused on being acquired, and not necessarily the focus of the acquirers. U.S. Attorneys reminded the audience that prosecutors examine conduct at the time it occurred. The government does not forget about fraudulent or other impermissible conduct once a company is acquired, and may seek enforcement against the individuals involved.
• Combating the opioid crisis: Government panelists made clear that the current opioid crisis is a chief priority. They pointed to the recent McKesson case — where McKesson agreed to pay $150 million for failing to detect and report “suspicious” orders distributed to its pharmacy customers — as a demonstration of liability up the supply chain.
• Donations to patient groups: Donations to patient assistance programs sponsored by charitable organizations were a regular theme at this year’s conference. Particularly troublesome are signs that companies are using donations to subsidize copays of patients who have Medicare, or urging charities to use funds solely for the company’s specific drug. “Charitable” activity will be scrutinized for signs that the company is measuring return on investment for different levels of donations or otherwise using donations to benefit the bottom line.
• Sunshine Act data is “front and center”: U.S. Attorneys discussed their frequent use of public physician payment data in investigations to focus on outliers. Read Guidehouse’s white paper that highlights the importance of companies getting out in front of their Sunshine data.
• Demonstrate a commitment to compliance: Using a “sign-in sheet” as an example, the government challenged companies to demonstrate that written standards are applied in practice. Are sales reps trained on sign-in-sheet requirements? Do you monitor and review sign-in sheets for compliance? Are the same attendees showing up at speaker programs? As we summarized in our white paper, the government distrusts “paper” compliance programs where policies are not followed through in practice, and the conference served as a reminder.
• Kickback scrutiny: The government outlined familiar areas of compliance focus — including speaker programs and fee-for-service payments. Panelists also warned that no matter how creative or complex an arrangement may be, the government is always on the lookout for arrangements that reward doctors for writing prescriptions.