As the federal government scrutinizes various programs that provide some form of assistance to patients, drug makers are responding inconsistently to the legal hazards, according to a new survey.
Approximately one-third of the companies queried say they have altered procedures for funding independent charities that provide financial assistance to patients, but very few are regularly monitoring or auditing the activities of their patient services teams. And 25 percent of drug makers report that they provide patient services, such as copay cards, to people using their medicines for unapproved uses.
Drug makers “need to make sure they have compliance controls in place to protect against potential suspicious activity,” said Manny Tzavlakis, managing partner at Helio Health Group, a regulatory consulting firm that surveyed 28 drug makers, including 12 large companies. The programs are “good for humanity, (but) watch (out) for bad folks.” Additional corporate integrity agreements he warned, are “on the way.”
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