Refill Reminder Programs May Be Next Free Speech Battleground For Pharma
This article was originally published in The Pink Sheet Daily
Adheris sues HHS, arguing rule requiring patient authorization of Rx refill reminders violates its First Amendment rights; complaint may test scope of Supreme Court’s Sorrell ruling.
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Pharmaceutical companies are spending more to help patients adhere to their therapeutic regimens – an almost universally recognized way to improve health outcomes and pharma’s bottom line. But an unclear legal and regulatory climate and poor understanding of the adherence problems it is trying to solve means industry isn’t trumpeting what could be one of its best health care value arguments.
The court affirms the Second Circuit's ruling that a Vermont statute prohibiting drug companies from using Rx data to market to doctors imposes an impermissible restriction on free speech.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.