Fierce Pharma August 25, 2023
With one week to go until the Centers for Medicare and Medicaid Services (CMS) releases its list of ten drugs up for the first round of pricing negotiations, AstraZeneca is jumping into the legal battle around the Inflation Reduction Act (IRA).
Unlike lawsuits from other drugmakers that hinge on constitutional arguments, AZ’s case centers on the 1983 Orphan Drug Act (ODA) and the “unintended consequences” of the new law. In a statement, the company said the IRA’s Medicare price negotiation measures “run headlong into the goals” of the ODA.
The ODA provides a seven-year market exclusivity period to encourage the development of therapies for rare and orphan diseases, AZ pointed out. Since the law’s passage, more than 600 medicines...
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