FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Charity Claims Federal Policies on Drug Assistance Violate First Amendment

Jan. 12, 2018
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A charity that helps low-income patients buy prescription drugs sued the federal government, claiming federal overreach left it unable to communicate with donors.

In its complaint, Patient Services Inc. (PSI) says current federal oversight violates its free speech rights and restricts its ability to transmit “truthful and nonmisleading information.” In 2017 guidance, the lawsuit states, HHS issued new restrictions on charities’ ability to communicate with existing and potential donors or their “affiliates.”  

PSI, founded by clinical counselor Dana Kuhn in 1989, uses funds from drugmakers to provide financial assistance for patients with numerous illnesses and chronic conditions, including breast cancer, sickle cell disease, exocrine pancreatic insufficiency and Gaucher Disease. The charity received more than $94 million in 2016 from dozens of drugmakers and other sponsors including Novartis, Bayer, Novo Nordisk and Shire.

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