False Claims Counsel

The OIG-HHS published the new CIA it entered into with Pfizer Inc., as part of today’s $2.3 billion settlement. A few noteworthy differences between this and other pharma CIAs:

• Instead of a 5-year term, the agreement calls for five reporting periods, the first of which extends from August 31 through December 31, 2010. This effectively extends the normal 5-year CIA period by three months.
• The scope of “promotional and product review functions” has been extended to include both Pfizer’s Medical Information Department (often called “Medical Affairs” in other companies), and R&D and publication activities, including post-marketing work.
• Audit committee and executive compliance certification – requiring the Board of Directors’ Audit Committee and certain executives to certify compliance is a common OIG-HHS demand recently; Pfizer has agreed to it in this CIA.
• Off-label requirements – the CIA expressly requires Pfizer sales reps to refer off-label inquiries to Pfizer’s Medical Information Department. Prior pharma CIAs typically described compliance obligations more broadly.
• Other compliance requirements are written in much more specific language than in prior CIAs.
• “Risk Assessment and Mitigation Plan” – Pfizer had implemented a set of procedures under the acronym RAMP, which permitted management to assess a variety of risks; the CIA requires the Company to continue this process for Government-reimbursed products.
• Independent Review Organizations – in addition to the commonplace systems and transaction reviews, the CIA requires Pfizer to employ an IRO to review the performance of its RAMP system.
• “Reportable events” (those about which the Company must notify the US) now include FDA warning letters.
• Field sales force monitoring: The Pfizer agreement broadens the oversight of its field sales force, requiring, for example, attorneys to conduct ride-alongs with sales representatives to assess their compliance.
• Speaker monitoring program: In addition to a field sales force monitoring program required in other CIAs, Pfizer’s requires it to implement a program to monitor speakers
• Headquarters monitoring: The CIA requires Pfizer to develop a monitoring program for consulting arrangements, publication activities, and medical education grants and health care-related charitable contributions.

Overall, Pfizer’s CIA is a remarkably detailed and stringent document. It remains to be seen whether this is a harbinger of things to come for other pharma companies, or reflects the OIG’s frustration at the fact that Pfizer was already operating under an earlier CIA when it settled these allegations.

Full Disclosure: I helped represent Pfizer when I was an attorney at Covington & Burling LLP.