CommCore Consulting Group and The Center for Communication Compliance (CCC) have formed a strategic alliance to help agencies bridge the gap between regulatory compliance education and compliant message development. The pairing combines much needed expertise and capabilities: CommCore, with its speaker training, message development, FDA preparation and crisis communications counsel and CCC, through its regulatory compliance training and certification programs for healthcare communicators.
New FDA leadership, new legislation, and new enforcement power all increase the responsibility of healthcare marketing and communication professionals to communicate effectively and compliantly -- both internally and externally.
"Our joint effort is a response to an unprecedented number of products facing recalls, Risk Communications (REMS) requirements and unease among patients, health care providers and regulators," says Andrew Gilman, President and CEO of CommCore.
"Healthcare marketing and communication professionals face an increasingly turbulent regulatory terrain. However, with careful planning, this new era presents opportunities to translate the realities of regulatory compliance into practical terms so that messages are hard-hitting, but also don't run afoul of regulations," says Jerry Doyle, Principal at the New York City office of CommCore.
"Today, healthcare communication requires a marriage between compliance know-how and effective messaging in order to have the greatest impact on business with the least amount of risk," according to Ilyssa Levins, CCC president and founder. "To accomplish this, promotional agencies must master three key steps: education on the regulatory requirements; demonstration of proficiency in the risk communication process; and application of the regulations to the business of risk communication."
CommCore and CCC have identified the new Risk Evaluation and Mitigation Strategy (REMS) requirements as a prime near-term opportunity for agencies to get more involved in risk management planning and discussions. A REMS must be submitted to the FDA for any drug product deemed to have serious risks -- either prior to the product's approval or even after the product is marketed. The FDA can delay approval if it deems the submitted REMS to be insufficient, and the regulatory authority can declare the product misbranded (and thus ineligible for marketing) if the company fails to follow the approved REMS. Several blockbuster products, such as Botox® (Botulinum Toxin Type A), now have a REMS requirement.
"Until now, promotional agencies have not had a soup-to-nuts support system to guide them through the ever-changing risk management terrain in a comprehensive way," states Doyle. He concludes: "Together, CommCore and CCC will help promotional agencies close that loop."
About CommCore Consulting Group
CommCore Consulting Group, www.commcoreconsulting.com, is an independent, privately-held firm providing communications counsel to businesses, government agencies, and non-profit organizations around the world. For the past 25 years the company has specialized in executive media skills and media interview training; presentation and speaker training; message development; multimedia communications strategy, including video production and social media; consultation on crisis planning and response; litigation PR; and citizen lobbying and advocacy. In healthcare, CommCore has counseled clients for FDA hearings, product launches and recalls, and scientific presentations. The company was founded by President and CEO Andrew Gilman -- a lawyer, award-winning journalist, and co-author of the best-selling book, "Get to the Point." CommCore is headquartered in Washington, D.C., and has offices in New York City and Los Angeles.
The Center for Communication Compliance (CCC), www.CommunicationCompliance.com, is the first and only centralized resource, training, and certification portal for healthcare communication designed to support and enhance regulatory compliance. This on-demand, online Web site administers the Regulatory Compliance Test (RCT), the only expert-reviewed test available for multiple communication channels that certifies competency in various aspects of healthcare regulatory compliance. CCC also offers the only standardized web-based regulatory training that directly correlates with the RCT. Headquartered in New York City, CCC also provides customized internal training, on-site workshops, consulting and diagnostics, and market research. CCC founder and President Ilyssa Levins has 30 years of healthcare communications experience; prior to founding CCC, Ilyssa was with Grey Global Group, one of the world's foremost communications firms, for two decades.