When it comes to patient support, the U.S. government is all in favor – depending on who is doing the supporting. According to Ron Wisor and Eliza Andonova, partner and counsel, respectively, in the health group at Hogan Lovells, when the party offering support has a financial interest, there are many important restrictions – as well as potentially harsh penalties.
“Pharmaceutical companies clearly have an interest in helping patients gain access to their products,” says Wisor. “And where drugs are very expensive and patients are low income, having that support is often essential. The problem comes when there is the appearance of a manufacturer either taking the place of a doctor in recommending their drug, or offering financial incentives that make it seem they are bribing patients to take it.
“It’s a tricky balance,” he continues, “because manufacturers are almost always wanting to do the right thing, but if they do it in the wrong way, they can get into big trouble. We ensure that they do it the right way.”
“For example,” says Andonova, “many drugs are subject to prior authorization reviews and appeals processes. A manufacturer may wish to provide assistance to patients in obtaining coverage from their insurance company or government-sponsored health care plan. But there have been recent enforcement cases where manufacturers have gone beyond just providing information and guidance in the prior authorization process, to actually doing it on the patients’ behalf.”
Ultimately, both the government and insurance companies want clinical decisions to be made by physicians in consultation with their patients. As the makers of the drug, pharmaceutical companies may indeed have more and better information about their product, but as regulators, the government doesn’t want a manufacturer helping a patient afford their medication to be the deciding factor in that patient choosing that product over another one.
According to Wisor, “Our services start with helping our clients structure their programs in such a way that they are in accordance with the law. We make sure they are implemented the right way and audited to ensure they remain in compliance.”
“At the end of the day,” says Andonova, “we want patients to get the support they need, and our clients to get the protection they need.”
To stay up to date on regulations that impact the life sciences industry, including those concerning patient support, subscribe to Hogan Lovells’ Focus on Regulation blog.
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