You 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.
The 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.
The 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.
But 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.”
Winkler 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.
But 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.”