Incyte ponies up $12M to settle charity foundation kickback claims; US exercises option for more doses of monkeypox vaccine
One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.
Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.
Federal prosecutors alleged that Incyte actively pushed for patients who were not eligible for the foundation’s help to be included on its rolls, even working to help those patients apply for aid through a contractor. The company “pressured the foundation, through phone calls and emails” to add patients who were deemed ineligible, the DOJ said.
It’s the latest settlement in a years-long crackdown on pharma charity foundations. The industry says those foundations are a mechanism to help patients who cannot cover their federal program copays to have access to key medicines. Meanwhile, the DOJ contends the programs are just a different form of patient kickbacks. — Kyle Blankenship
US exercises option for more doses of monkeypox vaccine
Now that just under half of Americans have received at least one dose of a Covid-19 vaccine, the US apparently has another vaccine on its mind.
BARDA is exercising a $12 million option to purchase more doses of Bavarian Nordic’s Jynneos vaccine for smallpox and monkeypox, the company announced on Friday. The option is part of a $202 million order made last April for up to 1.4 million liquid-frozen doses.
“This year, we are launching operations in our newly established fill and finish plant, which enables us to bring the final step of commercial manufacturing of JYNNEOS in-house as the first product on the line, marking a significant milestone in our long-standing partnership with the U.S. government,” CEO Paul Chaplin said in a statement.
Monkeypox is a rare virus that’s primarily native to Africa near tropical rainforests. It’s similar to human smallpox — causing symptoms “similar to but milder than” the infectious disease — and older smallpox vaccines have been shown to have a high degree of success in protecting humans from monkeypox.
Jynneos was approved by the FDA for prevention of both monkeypox and smallpox back in 2019. It’s based on a live, attenuated vaccinia virus, which can’t be replicated but is strong enough to induce an immune response. — Nicole DeFeudis
Drug regulators to pharma: Widen access to clinical trial data
An international group of drug regulators, including the FDA, EMA and WHO, called on the pharmaceutical industry on Friday to be more proactive in sharing clinical data for all new medicines and vaccines.
“Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted,” they said in a joint statement.
Echoing a similar call from two law professors last month, the regulators also stressed that data must be published when a regulatory review is finalized, especially if a drug is marketed. The push comes as the FDA for the first time cracked down on a pharma company that failed to post data for a failed trial to the US government database for clinical trials.
“ICMRA [International Coalition of Medicines Regulatory Authorities] and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health,” they wrote. — Zachary Brennan