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New Educational Program to Boost PR Compliance


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-07-02-2008
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With the launch of the Center for Communication Compliance, pharma companies and PR firms have a one-stop resource to educate themselves about marketing regulations in an effort to reduce accidental non-compliance.

In an effort to take a lot of the guesswork out of keeping public relations strategies on the straight and narrow, a new organization has been established to train and educate pharma about avoiding risk and fines.

The Center for Communication Compliance (CCC) was conceived as a place where professionals can obtain information on all the regulations regarding pharma press releases, as well as medical advertising in general. In addition, the CCC offers multiple training programs, testing, and certification for anyone who touches healthcare communications—primarily agencies that work for industry.

What separates the center from run-of-the-mill compliance experts and consultants? CCC is entirely Web-based, offering public relations people who are burning the midnight oil to access information any time of the day (or night).

What is 'Wrong Information'?
The brainchild of founder and president Ilyssa Levins, CCC aims to help pharma avoid the billions of dollars it spends each year to settle illegal promotion charges. "The need for [compliance education] started in late '80s, when FDA started regulating PR materials such as press releases and video news releases," Levins said. "Until then, public relations operated under the First Amendment—telling truthful information."

However, in the early 1990s, FDA proclaimed that video news releases were an extension of labeling, and must be regulated like advertisements. "That turned the PR world upside down," Levins said. "It used to be that the worst you would get was a warning letter, but now the federal government watching and indicting."

CCC was created to help agencies facing a wall of regulatory red tape get the information they need to avoid being fined.

Course Development
The Center charges for testing and consulting, but also offers an exhaustive collection of links to external resources for healthcare communication regulations and corporate integrity agreements. Other services include licensed testing, online courses, consulting and on-site educational programs. Training is standardized, ensuring that everyone is educated at the same base line, and according to Levins, the certification offered is solid proof of training in compliance.

Levins gathered half a dozen former FDA leaders, lawyers, regulators, and public relations professionals to build the program; all agreed on questions that would be included on the CCC's tests. Former FDA chief of consumer education and information Wayne Pynes leads the board of CCC, which is now establishing similar programs for medical education compliance, and will offer courses in global public relations in the near future.

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