pYou might have been afraid to attend the American Bar Association’s white-collar crime conference last week. But the Health Blog, armed with the First Amendment, endured the topic and the tropical clime of Miami to check out a panel on health-care fraud. /ppThe government and the corporate defenders were there. Big Pharma bogeywoman Susan Winkler, chief of the health-care fraud unit at the U.S. Attorney’s Boston office, shared the dais with defense attorneys Ty Cobb, Nicholas C. Theodorou, Katherine Lauer and Thomas Dwyer./ppThe group ran though the health-fraud hit parade: off-label marketing, assessing the value of a case and how a company, once cornered, can strike a productive note with the feds. /ppBut the thing that jumped out at us was the group’s consensus that smaller companies–biotechs and device companies—are expected to be the next big hunting ground for fraud and wrong-doing. “Small cap companies, biotech and medical device companies, their resources are limited in terms of compliance,” Theodorou said. And, he added, “they’re very sales and marketing driven.” /ppWinkler agreed, saying, “We’re going to see more and more off-label with medical devices.” The U.S. Attorney’s office in Boston has been a leader in rooting out health- care fraud, including cases against a host of drug companies. Sketchy pricing schemes and off-label marketing, or pitching a drug for uses beyond those approved by FDA, have been regular fraud fodder./ppBut Big Pharma, said the panel, has learned from its lumps after battling government investigations and charges. “There are a lot of drug executives walking around with huge dents in their heads,” Cobb said. “They’ve been beaten with rules and compliance.” It’s the little guys, particularly single-product companies, who don’t have the resources and infrastructure to set up checks and balances. The legal stakes can break a company, Cobb said. “I got a case where the first person I called wasn’t the forensics guy, but the bankruptcy guy.”/p
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