United States

Medical Affairs Under the Microscope

Jan 12, 2015
From the Healthcare & Life Sciences Institute

With corporate integrity agreements (CIAs) broadening in scope and strong pressure from federal regulators to create clearer separation between commercial (promotional) and medical (nonpromotional) activities, many life sciences organizations are starting to take a closer look at the structure, processes, and controls embedded within their medical affairs functions.

The ongoing trend towards healthcare convergence has seen the mandate of medical affairs functions broaden to include a wider range of healthcare professional activities, which, in turn, have increased the risk of noncompliance. And the risk will only grow as restrictions on physician detailing tighten.

Our experience suggests that many pharmaceutical, medical device, and biotech executives may be surprised by the gaps they find in their medical affairs compliance frameworks; they will want to move quickly to close them.