December 1, 2010

Physician advisory boards are being scrutinized more and more closely by regulatory agencies. OIG enforcement of anti-kickback statues has set new records over the last 18 months and the Patient Protection and Affordable Care Act signed into law in 2010 has made it easier for prosecutors to impose liability on medical product company management. But these advisory boards provide valuable insight into marketing and clinical issues for manufacturers — so management must figure out how to use them without risking running afoul of regulatory requirements.

In their December 2010 article, Developing Effective and Compliant Advisory Boards, published in PM360, authors Michael N. Abrams, M.A., Managing Partner, and Stephen E. Rothenberg, J.D., Business Analyst, describe what challenges manufacturers will face in convening advisory boards. The authors outline a comprehensive framework to engage physicians as advisory board consultants that will provide demonstrable value and comply with regulatory enforcement agencies anti-kickback statutes.