Home health remedies Patient charities ink deals to wrap up the Justice Department’s co-pay kickback...

Patient charities ink deals to wrap up the Justice Department’s co-pay kickback probe

18
0
SHARE

An industrywide federal probe into drugmakers’ use of charitable foundations to allegedly offer kickbacks for prescriptions of its drugs has netted some big fish in the last two years. Now, for the first time, two of the charities involved in the case have agreed to settle. 

Good Days and Patient Access Network Foundation will shell out a combined $6 million to close U.S. Department of Justice claims they operated as pharma front funds to effectively pay patients to take their drugs. 

Good Days President Clorinda Walley said in a statement the foundation would “continue to comply with all regulatory requirements surrounding charitable copay assistance programs and we welcome further clarity and (Office of the Inspector General) guidance to ensure we can continue to put patients in need first.”

As part of the deal, Good Days agreed to pay $2 million while PAN Foundation will shell out $4 million. Neither foundation admitted wrongdoing. 

Good Days, which previously operated under the name Chronic Disease Fund, was one of three foundations that Questcor, now a subsidiary of Mallinckrodt, allegedly used to subsidize patient co-pays for its H.P. Acthar Gel. 

In June, the DOJ filed new charges against Mallinckrodt, which acquired Acthar-maker Questcor Pharma in 2014, accusing the subsidiary of using illegal subsidies in order to jack up the drug’s list price 85,000%. Those charges came on the same day the drugmaker and DOJ agreed in principle to a $15.4 million settlement on separate charges tied to two whistleblower kickback suits. 

“As we have said repeatedly, where we can resolve legacy legal matters in a reasonable and manageable way, we will do so,” Mark Casey, Mallinckrodt’s general counsel, said in a statement at the time. “Unfortunately, that has not been possible to date regarding the allegations relating to Questcor’s charitable foundation activities, despite what we believe was lawful and appropriate activity.”

RELATED: Feds say Astellas, Amgen will fork over $125M to settle charity kickback probes

Mallinckrodt isn’t the only drugmaker that’s been under the DOJ’s microscope for donations to patient charities. 

In April, Astellas and Amgen inked settlements totaling $125 million on similar allegations. Neither company admitted wrongdoing and said they believed their actions were within the bounds of the law at that time. 

According to prosecutors, Astellas boosted sales of Xtandi, an androgen receptor inhibitor (ARI) that treats prostate cancer, by asking patient foundations to create copay funds specifically for the ARI category. There are no other ARIs among major prostate cancer meds, the feds said.

In July 2013, Astellas convinced two foundations to open ARI-specific copay funds, the feds said, and Astellas became the only donor to those funds. To increase prescriptions for Xtandi, Astellas then promoted those funds and their copay coverage to doctors, the DOJ said.

As for Amgen, the government claims it stopped donating in 2011 to a fund that supported patients taking any secondary hyperparathyroidism drug, including its own Sensipar. Then, the company allegedly worked with another patient foundation to create a fund that would only cover copays for patients using Sensipar.  

Drugmakers Jazz, Lundbeck and Alexion were also knocked in the federal probe, agreeing on a combined $122 million in settlements in April. Pfizer last May agreed to pay $23.8 million to resolve its own probe, while United Therapeutics inked a $210 million deal back in late 2017.

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

five × one =