The last 12 months has been busy with kickback probes, price gouging scandals and improper marketing practices, from a $38 million settlement to settle kickback charges from Allergan plc subsidiaries last December to a lawsuit over deceptive opioid marketing against Endo Pharmaceuticals plc just a few weeks ago.
In the United Therapeutics case, the government alleged that the company used a charitable foundation to pay co-pays for patients on its pulmonary arterial hypertension drugs, including Adcirca (tadalafil), Remodulin (continuous pump treprostinil), Tyvaso (inhaled treprostinil), and Orenitram (extended release treprostinil).
Between February 2010 and January 2014, the government claimed that United Therapeutics collected data from the foundation on the patients prescribed its drugs and the support provided, and then used this information to decide the amount donated back to the foundation. The biotech is also alleged to have directed Medicare patients away from its own free drug program and towards the foundation, in order to generate Medicare revenue and induce purchases of its own drugs.
In May 2016, the Department of Justice filed a subpoena to request documents to see the documents relating to these alleged practices, according to a United Therapeutics 8-K entry.
"UT used a third party to do exactly what it knew it could not lawfully do itself," said Acting United States Attorney William D. Weinreb. "According to the allegations in today’s settlement agreement, UT understood that the third-party foundation used UT’s money to cover the co-pays of patients taking UT drugs. UT’s payments to the foundation were not charity for PAH patients generally, but rather were a way to funnel money to patients taking UT drugs. The Anti-Kickback Statute exists to protect Medicare, and the taxpayers who fund it, from schemes like these that leave Medicare holding the bag for the costs of expensive drugs."
United Therapeutics has stated that the settlement "is neither an admission of facts nor liability by the Company, nor a concession by the United States Government that its contentions are not well-founded". The company has recorded a $210 million accrual relating to the settlement.
