Pharmaceutical companies, including AstraZeneca and Boehringer Ingelheim, are suing the Biden Administration over its plan to lower Medicare drug prices. They allege the administration violated the Administrative Procedure Act (APA) by trying to implement the pricing program through agency guidance rather than a formal regulatory process. Despite the litigation, the Inflation Reduction Act, which enforces the drug pricing program, may hinder the suits, especially when courts have interpreted it to include agency guidance. The companies claim the direction implemented changes that involved them in negotiations against the APA. Legal experts predict more procedural battles could ensue.
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[Source: Bloomberg Law, September 13th, 2023]