PM360 January 2010

COMPLIANCE CENTER

WHEN DO COMPARATIVE CLAIMS BECOME FALSE CLAIMS?
By Richard S. Lev, JD

Trying to differentiate your brand from the competition? Planning to present new comparative data in your next sales aid and possibly gain a few share points? Well, make sure to plan carefully before you execute your strategy because recent developments could significantly affect the risk level of your next campaign. 

As a pharmaceutical marketer, keeping your brand and your team within the various legal and regulatory guidelines can require a great deal of vigilance. As we have seen in the pharma industry, investigations into pharmaceutical sales and marketing practices by the HHS Office of Inspector General have continued unabated. Most high-level prosecutions have focused on off-label promotion and other suspect marketing practices. Keeping branding messages well within the approved product label has become second nature to sales and marketing teams and a routine part of doing business. 

Claims of Superiority
But if you think aggressive marketing claims are safe from the OIG so long as they stay within label, think again. Recent judicial settlements indicate that the Government has now begun to focus on comparative or superiority types of claims as a target for enforcement. The Government now considers that if a promotional claim of superior safety or efficacy versus a competitor product is not well substantiated by data—and this results in claims for reimbursement being filed with the Government—then this conduct violates the False Claims Act no differently than in the off-label promotion cases. So even though your claims of better efficacy versus a competitor are completely within the approved indication for those products, if the data relied on are weak or have been judged inadequate by the FDA, then the Government may view this conduct as fraudulently inducing prescriptions. 

Criminal Investigation
Comparative claims have always been an area of fairly strict regulation by the FDA. Not to mention the threat of potential legal complaints from competitors. However, with the OIG now effectively criminalizing this area of pharma marketing, what used to result in nothing more serious than a DDMAC letter may now become part of a criminal investigation. The OIG now looks closely at these DDMAC letters and can open an independent investigation. The legal risks become much greater when prior DDMAC warnings appear to have been ignored by a manufacturer. 

Therefore, comparative marketing strategies must be vetted thoroughly by medical, legal, and regulatory reviewers, and the level of scientific rigor must be high. Comparative claims should be well supported by adequate and well-controlled studies and must not be exaggerated or otherwise misleading. Field sales representatives must be carefully trained in the delivery of comparative claims and should stick to only approved messages and materials. Policies and procedures should be put in place to ensure compliance and to detect and correct deviations.

Richard S. Lev is the Chief Compliance Officer at Publicis Strategic Solutions Group in Somerset, NJ. He can be reached at richard.lev@psellingsolutions.com