Haider Andazola

Nov 28, 2024 | jdsupra.com | Haider Andazola |Ross Margulies

This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments.

Nov 22, 2024 | mondaq.com | Ross Margulies |Haider Andazola

On November 12, Johnson & Johnson (J&J) filed suit against the Health Resources and Services Administration (HRSA) in D.C. federal district court, arguing that the 340B statute explicitly provides flexibility for manufacturers to decide how to offer 340B pricing, either through upfront discounts or post-purchase rebates, and that HSRA has not prohibited such an arrangement through its agreement with manufacturers (known as the Pharmaceutical Pricing Agreement (PPA)).

May 14, 2024 | jdsupra.com | Jesse Alderman |Haider Andazola |Regina DeSantis

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More specifically, the Department of Justice (DOJ), which has authority over the DEA, submitted a formal rescheduling recommendation to the White House following an August 2023 recommendation from the Department of Health and Human Services (HHS) to the DEA to reschedule cannabis.

Nov 8, 2023 | jdsupra.com | Haider Andazola |Thomas Barker |Erin Estey Hertzog

Key Takeaways: On November 3, 2023, a Federal District Court issued a decision invalidating the Health Resources and Services Administration’s (HRSA’s) 340B “patient” definition.

Aug 30, 2023 | jdsupra.com | Haider Andazola |Erin Estey Hertzog |Ross Margulies

Key Takeaways: This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program. The list includes 10 drugs with the highest spending in Medicare Part D.