Compliance Specialist, PharmaCertify™
In the film, The American President, the campaign slogan of the challenger to the incumbent president is “it’s time to get the pride back.” This week’s CBI Compliance Congress had a similar rallying cry of “it’s time to get the trust back” – the trust of the public that is. Opening remarks by Doug Lankler, Executive Vice President and Chief Compliance and Risk Officer at Pfizer, and the keynote address by Geno Germano, President and General Manager, Specialty Care and Oncology at Pfizer, set the tone for the theme. As Mr. Germano pointed out, there was a time when the industry was revered and trusted by the public. Now, it regularly trades places with the oil and banking industries as the most distrusted industry in America and vast amounts of time and resources have been spent to address the issues behind this reputation. Mr. Germano believes that if the industry is to thrive going forward, it has to start by earning back the trust and respect of the public it once held, and it must be done now. In his opening remarks, Mr. Lankler emphasized that a compliance failure at one company represented a compliance failure for the entire industry. He noted the importance of companies learning from one another and sharing experiences (respecting anti-trust laws of course).
The idea of gaining trust, building values-based compliance systems and working together carried through to the Boot Camp breakout, other presentations and panels during the Congress. Michael Shaw, Vice President and Chief Compliance Officer, North America Pharmaceuticals for GSK, summarized the notion during his presentation when he said that sustainable concepts are the key as we work in a changing landscape and that “we have to pull it back to principles.”
The enforcement panel on Day 1 was by far one of the best I’ve attended. During a discussion covering emerging trends in state-based enforcement, panelists pointed out that as more states pass their own False Claims Acts, their AG offices are becoming more comfortable with the cases. The overall feeling was that more states (in groups or possibly alone) will pursue actions against the industry for FCA violations, whether the feds participate or not. Violations that implicate the states’ False Claims Acts may also implicate consumer protection laws, and the industry may begin to see states pursue action under those laws.
The panelists were asked about the future trends in off-label cases. Happily, Sara Bloom, Assistant U.S. Attorney, District of Massachusetts, said she felt optimistic that cases with off-label violations as we know them are largely over. The panel identified false and misleading comparisons between products and misleading claims of economic superiority as off-label risk areas. Ms. Bloom went on to say that small companies who thought they may have been off the radar, were very much on the radar now.
Jean-Ah Kang, Special Assistant to the Director of the Office of Prescription Drug Promotion indicated that guidance regarding the use of social media was still on the docket, but she gave no estimated time of arrival for the guidance. Ms. Kang also highlighted the OPDP’s work to educate physicians about its Bad Ad program. Outreach efforts, including presentations at professional conferences, have been focused on educating physicians on how to submit promotional information that may represent a violation. She reminded the audience that the program does not just apply to advertisements in journals, sales piece or DTC ads, but also what reps say in a physician’s office and information presented at speaker programs.
How does CMS intend to implement the Sunshine Act? “Slowly and deliberately,” says Jack Mitchell, Chief of Oversight and Investigations, Senate Special Committee on Aging. While Mr. Mitchell provided no hint as to when the final guidance could be expected, he did admit that there were issues with the current guidance, and a timely release could be a challenge since this is an election year. However, the Committee is focused on working more proactively with CMS on the approval of the final guidance.
Speakers at the Sunshine and aggregate spend breakouts were less optimistic. Panel participants felt there won’t be a report required for this year, but CMS may require the industry to go ahead and gather data. The panel emphasized that those in the industry need to be concerned beyond the U.S. now that France has passed a similar law and countries like China are considering the same type of regulations. Other countries are no longer waiting to see what happens with Sunshine here in the U.S., so this has become a true global issue.
During his breakout session presentation covering social media, Jim Zuffoletti, President of OpenQ, stressed the life sciences industry has the most to gain and the most to lose from the “social enterprise.” Eye-opening statistics were presented highlighting how social media is taking over the way we communicate. Communication through social media rather than email is fast becoming the preferred method for customers interested in reaching out to companies. As companies launch into the social media world, they must be conscious of the audiences they are reaching through various platforms, and the need to monitor the interactions on the front end.
Even though I typically walk away from compliance conferences with good information, I tend to feel a little beat up and discouraged about the industry. That wasn’t the case with CBI’s 9th Annual Pharmaceutical Compliance Congress. This time, I felt encouraged and excited about the future of the industry. Yes, there are new and exciting areas of enforcement with which we need to contend (did I mention the prediction of the loss of exclusivity as a “what’s next” with regards to dealing with violations of promotion regulations?), but this is a wonderful industry. As was pointed out in the keynote address, our work saves and improves lives. It is noble work. The industry has come a long way since the first investigations back in the early 2000s. Mr. Germano was right when he said the time to “get the trust back” is now. After this week, I feel certain the industry is well on its way to doing just that.