Pharma companies have inked a series of federal settlements over payments to charity organizations, which the federal government argues are a “conduit” to boosting drug sales. Now, after an opioid investigation, two Senators want all those charity payments disclosed publicly.
And they have just the mechanism for it. Sens. Chuck Grassley and Ron Wyden have called for an expansion of the Centers for Medicare and Medicaid Services Open Payments database. That database now includes payments from pharma companies to doctors and other medical providers, but the senators propose adding payments to tax-exempt groups, too.
Further, the senators have called for a new requirement that the HHS secretary formulate guidelines to boost transparency around research organizations and others contracted by the health agency.
The senators made their recommendations last month in a much broader report on the opioid crisis. In their probe, the senators found that connections between opioid manufacturers and tax-exempt groups had served to boost sales while playing down addiction risks.
Specifically, they found $65 million payments from opioid manufacturers to such organizations as the American Chronic Pain Association and Americans for Patient Access since 1997. And those organizations appear "to have echoed and amplified the business interests of their pharmaceutical donors," the senators found.
It's an extension of Grassley's decade-long effort to shine a public light on pharma payments. For years before the Affordable Care Act, Sen. Grassley worked to pass The Physician Payments Sunshine Act, which proposed requiring pharma's payments to doctors to be public knowledge. The requirement passed as part of the ACA in 2010. In 2015, he worked to close a loophole that exempted nurse practitioners and physician assistants.
Meanwhile, the federal government has been investigating connections between pharma companies and patient charities in a probe that spans the industry and numerous therapeutic areas. Some of the industry’s largest players have inked settlements, but in some of the deals, companies have maintained that they did no wrong.
Gilead, for instance, inked a $97 million deal back in September, but the company’s general counsel Brett Pletcher said at the time the company “does not believe it violated the law and had no intention of doing so.”
The company “made its donations following guidance issued by the U.S. Department of Health and Human Services that permits companies to make donations to assist patients with their required copays for medications,” Pletcher said. Further, there “was never any allegation in this case that patients who received aid and medication did not need it or did not benefit from it.”
Aside from Gilead, companies including Sanofi, Pfizer, Astellas, Amgen, Alexion and United Therapeutics have inked charity kickbacks settlements in recent years.