According to the court document, HHS sees Pfizer’s efforts to help Medicare beneficiaries afford its Vyndaqel and Vyndamax drugs to be an illegal kickback scheme. Pfizer alleged HHS’ regulatory action violated its constitutional rights to free speech and due process.
Drugmakers are not allowed to subsidize copayments for Medicare patients, but they can donate to nonprofits that provide copay aid.
Vyndaqel and Vyndamax treat transthyretin amyloid cardiomyopathy, a condition that can result in progressive heart failure or death if left untreated. They are among the most expensive heart disease drugs in the market.
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