By Sean Murphy
Senior Account Manager, PharmaCertify
Whether delivered from government regulators or pharmaceutical industry leaders, the take away messages from PCF’s Eleventh Annual Pharmaceutical Regulatory and Compliance Congress could be whittled down to three key points – personal accountability for executives is coming, it’s time to integrate commercial compliance awareness and training into everyday business activities and global transparency management, and, relevance to the FCPA needs to be a focus for any company doing business worldwide.
The preconference sessions offered a series of important background presentations that set the stage for three days of lively conversation and interaction. Sessions included an overview presentation conference, with a review of the laws, regulations and federal sentencing guidelines, by Wendy Goldstein of the firm Epstein, Becker & Green PC. Kelly Freeman, Ethics and Compliance officer, Eli Lilly and Company, offered tips for implementing the seven elements of a compliance program, as suggested by OIG policy. Slide decks for both presentations can be found on the conference website at www.pharmacongress.com.
Day 1 of the conference, started with an audience in rapt attention, as Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General, presented a comprehensive update of recent settlements and the OIG’s focus going forward. Personal responsibility and convictions for pharmaceutical executives is on the horizon and Ms. Riordan made no secret of the potential for personal exclusion to government reimbursement programs being part of those convictions. She also reviewed the groundbreaking Synthes/Norian case in which settlement terms included the requirement for Synthes to divest itself of Norian. As part of the settlement, three executives of Norian pleaded guilty to misdemeanor violations of the FDCA and are awaiting sentencing. In addition to her review of current pharmaceutical settlements, Ms. Riordan emphasized that the trend toward more cases focused on the medical device industry will continue.
Day 1 concluded with a strong panel session of pharmaceutical industry compliance leaders who discussed their companies’ approach to integrating compliance into the business units, and the need for combining a rules-based approach versus a values-based approach to the training. Caroline West, of Shire Pharmaceuticals told the audience that taking training to the next level has been a priority. A “check the box” mentality is no longer enough. Michael Shaw of GlaxoSmithKline explained that the compliance messages at his company are no longer being driven by the compliance department but by the individual business leaders. Douglas Lankler pointed out that Pfizer has even taken the steps to brand their compliance efforts with the moniker, “It’s Mine,” to remind all employees of the on-going need to take ownership of the efforts.
Considering the questions around inclusion of elements of the Sunshine Act in the recent Healthcare Reform Bill, the opening presentation for day 2 by Maggie Feltz of Purdue Pharma was well timed. Her slides can also be found on the conference website and offer a solid summary of the state of federal transparency. During a follow up panel session on the Federal Sunshine Act and State Laws, Rore Middleton of Purdue reminded attendees of the need for continuous training by explaining “we pull reps in often for the training and they understand that they are the first line of ownership.” The bulk of the second day was structured so attendees could chose one of many separate session tracks, depending on their interests, including auditing and monitoring, internal and external investigations, research and development and the FCPA. Prior to a closing plenary session that offered compliance reports from different parts of the world, Ted Acosta, principal at Ernst & Young LLP offered the sobering statistic that the “typical pharmaceutical company has approximately 25 million global interactions per year” and therefore that many chances for a violation of the FCPA.
Day 3 of the conference began with those in attendance being asked what they would like to hear discussed by that day’s panel former regulators. Fittingly, the overwhelming choice was “How to Avoid Being the Subject of an Investigation.” Brent Saunders, Chief Executive Officer of Baush + Lomb, and a former compliance officer, delivered a closing keynote on the compliance perspective from private equity and the C-suite. An overarching point to Mr. Saunders’ presentation was that “the Chief Compliance Officer needs to be more than just a partner to business leaders, that person should be one of the business leaders,” echoing the message presented on Day 1 by Michael Shaw of GSK and others throughout the entire conference.
For a review of each days agenda for the Eleventh Annual Pharmaceutical Regulatory and Compliance Congress, and access to many of the slide presentations, visit, www.pharmacongress.com.