NEW YORK (Legal Newsline) – Pfizer says the federal government is keeping it from getting two of its drugs to patients with a rare and fatal heart condition.
The company sued the U.S. Department of Health and Human Services on June 26 in New York federal court, claiming regulations are blocking it from offering financial assistance to patients in need of Vyndaqel and Vyndamax to treat their Transthyretin Amyloid Cardiomyopathy.
The company worries it will be penalized for offering to help patients with their copays because of regulations that would consider the ensuing purchases as illegal kickbacks.
“Accordingly, before providing financial assistance to Medicare Part D beneficiaries who cannot afford the out-of-pocket costs of tafamadis, Pfizer is forced to seek a declaratory judgment from this Court that its proposed programs do not violate federal anti-kickback laws,” the complaint says.
ATTR-CM causes the heart to stiff, limiting its ability to pump blood. Pfizer’s medications are the first and only FDA-approved drug treatments.
“Its approval is a major medical advance that offers real hope to patients suffering with this devastating condition,” the lawsuit says.