The Center will feature a website helps pharmaceutical, medical device, and biotech companies, and their public relations, advertising, and medical education agencies, navigate an increasingly complex regulatory environment. CCC has also developed and will administer an expert-reviewed test available for healthcare communication professionals that certifies regulatory compliance competency. ”The test represents the core level of competency that is required in healthcare communication,” says Levins
“We brought together the tools and expertise the industry needs to set a new standard for regulatory compliance before one is set for us,” says Levins, CCC’s founder and president. “Every violation is another blow to the industry’s reputation, so we must move fast.”
At the May 13 meeting of the Regulatory Affairs Professionals Society, Michael Loucks, chief of the healthcare fraud unit and assistant U.S. attorney for the District of Massachusetts questioned whether the industry is doing all that it can to ensure compliance with government regulations. Companies, particularly pharmaceutical firms, have paid about $6 billion in fines this decade for off-label promotion under the False Claims Act alone.
And Wayne Pines, former FDA associate commissioner for public affairs and chair of the CCC advisory board, says: “The application of regulatory policy is constantly evolving. Every new FDA enforcement letter or settlement by the Department of Justice has the potential for generating a new policy. Keeping up with regulatory changes around drug and device promotion is every professional’s responsibility to reduce risk.”