Cost can be high for regulatory noncompliance
April 22, 2010 – 8:39 am by Steven NilesTonight, following the 21st Annual Manny Awards honoring outstanding acheivements in healthcare advertising, our April issue will be unveiled along with all the winners. Meanwhile, our May issue, including one of our regular features on promotional medical education, is in full production.
For last year’s promotional medical education feature, I had an opportunity to speak with Ilyssa Levins, president, Center for Communication Compliance about the advantages agencies might find in compliance training and certification. You can read the interview here. CCC offers agency executives and staff regulatory compliance training and certification across five channels: advertising, promotional medical education, public relations, managed care, and core global programming.
Now, a year later, Ms. Levins got back in touch with me to bring me up to date on her organization. The most recent big news is that International Meetings & Science (IMsci), a division of WPP, has become the first and only promotional medical education agency in the United States to certify its entire staff in regulatory compliance. CCC administered the expert-reviewed training and correlated certification testing, which confirms mastery over current, job-relevant, and expert-reviewed content.
“We are fully committed to promotional education compliance and to developing a culture of compliance from top to bottom,” says Barbara Blasso, president, IMsci. “That means training and certifying our employees to reduce legal and financial risk for themselves, as well as their clients, and to clearly differentiate our company in the marketplace.”
CCC had prevously announced certification of the first and only public relations agencies in December 2009, specifically IPG agency Weber Shandwick and Omnicom’s Porter Novelli.
In our conversation yesterday, Ms. Levins expressed surprise that agencies in promotional medical education and public relations are recognizing the importance of regulatory compliance certification while advertising agencies have been slower on the uptake.
“When we spoke at the time of CCC’s launch, we agreed that confirmation of regulatory savvy through a certification test seemed like a no-brainer for agencies (especially given our low price points),” Ms. Levins says. “Yet, despite all the benefits of our coursework, agencies were surprisingly slow back then to make regulatory compliance savvy a requisite for client partnership.”
CCC now trains and certifies in 44 countries in addition to the United States. Diversified Agency Services, a division of Omnicom Group, has committed to train and certify its senior team of integrated global healthcare strategists.
In fact, Rob Dhoble, DAS Healthcare president – who will accept his Manny award tonight as Advertising Person of the Year – has always believed that regulatory compliance training and certification is a strategic investment.
“Our clients expect us to share responsibility for developing communications with a thorough understanding of the complex regulatory environment around the world,” Mr. Dhoble says.
Two of the three ad agency nominees for this year’s Manny for Most Admired Agency – Cline Davis & Mann and Harrison and Star – are investing in CCC regulatory compliance training. Both are DAS network agencies.
Despite this step forward, Ms. Levins is still surprised to get push back from agencies, even with the DOJ/FDA threat of jail time recently reported in the Wall Street Journal.
“True, the economy remains an obstacle as many agencies don’t have budgets for regulatory compliance education (a non-billable expense), but the cost of noncompliance is simply too high to sit back,” Ms. Levins says.
As she sees it, the cost of noncompliance includes:
- Threat of jail time, conspiracy suits, and disbarment
- Fines and legal fees for both a company and individuals (from C-Suite executives to middle management)
- Profitability drains from redoing materials that won’t pass regulatory muster (CCC provides a calculator that lets agencies see for themselves how much redoes cost them)
- Significant disruption of business and workplace morale when files are subpoenaed
- Strained relationship between company and agency over compliance
- Damage to company’s reputation from continued reports of wrongdoing
“True, some agencies have a general compliance training program,” Ms. Levins says. “But in today’s regulatory climate, the question being asked by prosecutors is whether those programs are effective. Just because training is in place does not mean that the company’s employees are qualified. For training programs to be useful, you need a corresponding test that confirms mastery of the information. More importantly, certification tests are negotiating tools when dealing with the government, according to legal and regulatory experts.”
For agency leaders who believe that their current training programs are satisfactory, Ms. Levins challenges them to confirm that belief by asking senior staffers to take one of CCC’s free sampler certification tests. Not only that, but CCC is willing to give a few free pass codes to its full certification tests.
“We are willing to put our money where our mouth is,” Ms. Levins says. “Not because we want to be right, but because we want to help.”
Tags: advertising, business, Center for Communication Compliance, healthcare advertising, Manny Awards, regulatory compliance
