Off-label Marketing is "Dead," Diversion Cases on the Rise

"Off-label marketing is dead so-to-speak. There's been a death knell of that."  That news was delivered by Charlene Fullmer, Deputy Director of the Department of Justice's Affirmative Civil Enforcement ("ACE") unit in Philadelphia at the Pharmaceutical Compliance Congress and Best Practices Forum. Fullmer was joined by colleagues Kristen Williams and Jeff Steger for the AUSA panel, an annual event at the Compliance Congress that offers insight into what's coming across the desks of top attorneys at the DOJ.  As Fullmer explained it, the DOJ continues to prosecute pharmaceutical companies for off-label marketing. However, the agency is seeing fewer cases involving large pharmaceutical companies and more off-label marketing by small companies and medical device manufacturers. The Eastern District of Pennsylvania is also seeing a lot of cases involving off-label promotion in exchange for kickbacks. On the criminal side, Fullmer's unit is expanding the strategies and theories it uses to investigate acquisitions and communications by acquired companies to purchasers related to ongoing litigation and off-label promotion of products. Besides investigating these acquisitions under the Food, Drug and Cosmetics Act, the agency is also looking at securities violations and conspiracy theories.  The DOJ is also working with the Department of Health and Human Services to prosecute pharmacy diversion cases. These cases are skyrocketing and taking a tremendous am...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs