Buchanan Ingersoll & Rooney has recently launched its Buchanan Compliance Counseling Program, which provides a cost-effective way to stay abreast of the Federal Sunshine Act and related state laws that apply to the marketing and sale of pharmaceutical, medical device and biologic products.

Marketing and selling FDA-regulated products is an increasingly complex endeavor. In addition to complying with federal requirements, pharmaceutical, biologic and medical device companies are required to comply with state laws that impose additional expenditure tracking and reporting requirements.

The Buchanan Compliance Counseling Program provides legal counsel, on a yearly subscription basis, in the following areas:

    • Aggregate Spend & Federal Sunshine Act
    • Code of Conduct Adherence (including Annual Declaration of Compliance)
    • Gift & Meal Bans/Spending Limits
    • Pharmaceutical Detailer Licensure & Continuing Education Requirement
    • Price Disclosures
Clients are alerted when states impose new requirements or amend/clarify existing laws. In addition, the program enables companies to be proactive in meeting compliance requirements through a yearly deadlines calendar and executive overview of existing legal requirements. We also provide ready access to current laws, regulations, guidances and reporting forms.

This year, we anticipate adoption of a final rule to implement the Federal Sunshine Act. Existing clients already have the benefit of an executive overview of the proposed rule, released in December 2011. Upon release of the final rule, clients who subscribe to our program will receive an executive overview of that final rule, as well as analysis of how the preemption provision of that law impacts existing state law obligations.

This innovative program is an economical way to tackle the challenges that the Federal Sunshine Act and related state laws pose. For more information about the Buchanan Compliance Counseling Program, contact: Linda Pissott Reig at linda.reig@bipc.com or 973-424-5618.