After hearing a fellow panelist report that 70% of False Claims Act penalties are for healthcare fraud settlements, FDA deputy chief counsel for litigation Eric Blumberg told a December conference that “Money is clearly not doing the job…We need to employ a ‘bigger hammer,' to send people to jail.”
Blumberg wants to see greater use of the Park Doctrine, which lets prosecutors hold corporate executives personally responsible for regulatory infractions without need to prove prior knowledge or intent to defraud.
Under the doctrine, Blumberg explained, corporate executives and managers have not only a positive duty to seek out and take steps to eliminate fraud, but also a duty to put into place policies and procedures to prevent violations.
Told by other panelists that FDA's use of the Park Doctrine has prompted more extensive compliance training for employees, Blumberg said that's not enough. “CEOs must set up systems to prevent off-label promotions,” he asserted.