Summary: AstraZeneca Pharmaceuticals LP has initiated legal proceedings against the U.S. Department of Health and Human Services (HHS), specifically targeting Secretary Xavier Becerra and Administrator of CMS Chiquita Brooks-LaSure. The lawsuit primarily disputes the Inflation Reduction Act of 2022 (IRA) and the recent guidance issued by the Centers for Medicare & Medicaid Services (CMS) concerning drug pricing negotiation stipulations. AstraZeneca contends that the IRA's drug pricing stipulations are at odds with the objectives of the Orphan Drug Act, a federal law intended to incentivize manufacturers to develop new treatments for rare diseases. The pharmaceutical company asserts that the IRA's cost-reduction strategies will adversely affect patients requiring novel therapies for their rare conditions. The lawsuit also questions the constitutionality of the IRA, positing that it infringes upon due process principles by compelling manufacturers to comply with the agency's imposed price or risk a tax penalty amounting to up to 95% of the drug's total U.S. revenues. AstraZeneca further disputes the IRA's clause that prevents judicial review for significant aspects of the drug price negotiation scheme. AstraZeneca additionally alleges that CMS's guidance documents contravene the IRA in two distinct ways. Firstly, CMS is accused of altering the statutory definition of a "Qualifying Single Source Drug" (QSSD), broadening the definition to encompass all dosage forms and strengths of any drug marketed by the manufacturer with the same active ingredient. Secondly, CMS is accused of extending the prerequisites that must be fulfilled before a drug is considered to have generic competition, introducing a new test to ascertain whether it has been the subject of "bona fide marketing". The lawsuit asserts that these actions by CMS infringe upon the Information Quality Act (IRA) and the Administrative Procedure Act (APA), as they contradict the text of the agency's governing statute and are arbitrary and capricious. AstraZeneca is requesting expedited briefing in this administrative record-based case to facilitate a prompt decision.