At first glance, it seems like a logical idea: pharma companies teaching doctors' staff how to handle patients using their drugs and helping staffers with reimbursement questions. But a slew of companies are discovering that it's not so simple.
In fact, it might just be against the law.
Biogen, Sanofi and Gilead Sciences are under investigation by federal and state authorities for offering reimbursement services and clinical education programs, the companies have disclosed in securities filings. Additionally, Bayer, Amgen and Eli Lilly face whistleblower lawsuits over the issue. The probes were first reported by the Wall Street Journal.
The news follows a lawsuit against AbbVie, filed by authorities in California last week, alleging that the company hired a network of “ambassadors” to provide care and assistance to patients in their homes. California says AbbVie provided nurses to physicians at no cost in exchange for Humira prescriptions. An AbbVie spokesperson said the allegations are “without merit.”
In Sanofi’s case, the U.S. Attorney’s Office for the Southern District of New York sent the company a civil investigative demand in August 2017 “requesting documents and information relating to Sanofi US’s certified diabetes educator program during the period from 2007 to the present.” The company said it’s cooperating.
A Sanofi spokesperson said nurses in the program were certified in diabetes education and worked with patients on product training and answered questions about the disease. The program is no longer running, she added.
Gilead, for its part, disclosed in an SEC filing that in September 2017 it received a voluntary request from the U.S. Attorney’s Office for the Eastern District of Pennsylvania seeking information “related to our reimbursement support offerings, clinical education programs and interactions with specialty pharmacies for Sovaldi and Harvoni."
The next month, the California Department of Insurance and the Alameda County District Attorney’s Office requested “documents related to our marketing activities, reimbursement support offerings, clinical education programs and interactions with specialty pharmacies,” according to a Gilead filing. Gilead said it’s cooperating in both cases.
And in an SEC filing last year, Biogen disclosed that in December 2016 it “received a civil investigative demand from the federal government for documents and information relating to our relationships with entities providing clinical education and reimbursement support services.” The company said it was cooperating, and it didn't list the investigation in its most recent annual SEC filing.
Aside from those investigations, Amgen, Bayer and Eli Lilly face whistleblower lawsuits alleging that such services are kickbacks, according to the Wall Street Journal. Representatives for Bayer and Eli Lilly told the newspaper the lawsuits have no merit. Amgen declined to comment, according to the WSJ. A judge tossed the case against Eli Lilly last month on grounds that the allegations weren’t specific enough, but he gave the plaintiffs a chance to restate their claims.