By Saul B. Helman, J. Mark Farrar, Casey Horton, Ann E. Beasley, Stephanie M. Lewko, Johna Carufel
The 19th Annual Pharmaceutical and Medical Device Compliance Forum (PCF) was held in Washington, DC, in November. The conference was attended by 450 people, including pharmaceutical and medical device manufacturers and representatives from government agencies, academic institutions, industry associations, and outside service providers.
Jeffrey M. Kawalek, MBA, senior director, Ethics and Compliance, North America, for Ipsen Biopharmaceuticals, Inc., provided attendees with a look back to the first conference held in 2000 to see what’s changed and what hasn’t. While attendance has grown from 135 in 2000 to 450 in 2018, the topics, though increasing in complexity, remain similar. Today, the industry is still grappling with how to manage the risks associated with the complexity of engaging and interacting with healthcare professionals (HCPs).
PCF attendees heard from government leaders from the Department of Justice (DOJ), Office of the Inspector General (OIG), Federal Bureau of Investigation (FBI), and the Food and Drug Administration (FDA). These experts described the collaborative culture and coordinated efforts that have evolved over the past year as they gather and share data focusing on healthcare fraud. All agencies have had an increase in resources, hiring additional auditors and fraud examiners while creating new task forces. The government leaders shared the following as their areas of focus in the coming year:
The DOJ panel included specific information that assistant U.S. attorneys consider when evaluating a compliance program. Topics included:
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Saul B. Helman, MD
saul.helman@guidehouse.com
J. Mark Farrar
mark.farrar@guidehouse.com
Casey Horton
casey.horton@guidehouse.com
Ann E. Beasley
ann.beasley@guidehouse.com
Johna Carufel
johna.carufel@guidehouse.com
Stephanie M. Lewko
slewko@guidehouse.com