HHS Rescinds Approval of Drug Charity that Allowed Pharma Influence

HHS has rescinded its approval of a major charity, Caring Voice Coalition, after the charity allowed pharma donors improper influence over the nonprofit.

According to a letter from HHS’ Office of the Inspector General (OIG), the charity provided drug makers with data that could allow them to see if their contributions were assisting their own customers, potentially giving companies “greater ability to raise the prices of their drugs while insulating patients from the immediate out-of-pocket effects.”

Under federal law, drug companies cannot give direct co-pay assistance to patients covered by Medicare because such a practice could steer patients from one drug to another. Drug makers can, however, donate to independent charities that help cover drug costs of Medicare patients if they do not influence the operations of those charities.

The OIG said that, “effective immediately,” it is rescinding its previous approval of the charity. Caring Voice “allowed donors to directly or indirectly influence the identification or delineation” of its disease categories, which contradicted previous reports that it would not do so, said the letter. OIG’s findings are similar to issues brought to light by Bloomberg Businessweek in May 2016, which found that Caring Voice gave special treatment to patients of some company donors.

The decision to eliminate Caring Voice’s approval comes amid a wide-ranging investigation by the Justice Department into pharma’s influence over charities. Jazz pharmaceuticals has recently received three subpoenas from the Justice Department relate to its relationship with co-pay charities. Celgene Corp., United Therapeutics Corp., Pfizer Inc., and Gilead Sciences Inc., have also received similar subpoenas.

According to Bloomberg, Caring Voice may be forced to close after having its approval rescinded, potentially impacting patients’ ability to pay for expensive medications.