Pharma’s Procedural Attack Opens New Front in Drug Price War

The pharmaceutical industry is expanding its attack on President Joe Biden’s plan to lower Medicare drug prices into allegations that the administration violated procedural norms in implementing the program, a tactic legal experts say will run into roadblocks but that could ultimately prevail.

AstraZeneca PLC and Boehringer Ingelheim are suing the Biden administration, alleging it violated the Administrative Procedure Act by trying to institute the drug pricing program via agency guidance rather than the formal regulatory process.

The APA claims mark important additions to “the litigation saga” unfolding around drug pricing, said Margaux Hall, partner in Ropes & Gray LLP’s ...