If you think drugmakers have legal troubles now, just wait. That's the promise of the U.S. Justice Department, which says it's planning to crack down hard on overseas corruption and healthcare fraud. And if a pharma firm is caught with its hand in the cookie jar--or handing out cookies to foreign officials--enforcement won't stop with the corporations. Senior executives could find themselves in the dock, too.
"The industry must resist shortcuts," Assistant Attorney General Lanny Breuer told a forum on pharmaceutical regulation and compliance (as quoted by Reuters). "It must resist the temptation and the invitation to pay off foreign officials for the sake of profit." For "pay off," read offer cash, gifts, travel, meals, entertainment, speaking fees, consulting arrangements, et al. And Breuer cautioned companies against thinking that only government types are bribe recipients. Payments to doctors, pharmacists, even lab techs could qualify as bribes, he said.
Another assistant AG, Tony West, pledged his own crackdown, this time on healthcare fraud. "In those cases where the facts and law allow us to pursue criminal cases against individuals responsible for illegal conduct, we will do so," West said (as quoted by Legal Times).
Two thoughts: The recent spate of enormous off-label marketing settlements has been hashed over a hundred ways. One common theme is whether even multibillion-dollar payments are a deterrent. Justice isn't talking about mismarketing infractions here, of course. But if prosecutors really intend to pursue executives personally, rather than stopping at the articles of incorporation, that's a game-changer for enforcement, in whatever sphere.
Second, we find it a bit odd that Justice so specifically pointed out that payments to foreign docs and pharmacists might be considered bribes. Of course here's been quite a bit of pressure for drugmakers to scale back on gifts to doctors and disclose any financial relationships. But no one has suggested prosecuting pharma for bribery in the U.S. So what changes at the border?