The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
With the U.S. Centers for Medicare & Medicaid Services soon expected to publish the list of 10 drugs selected for the first round of the Inflation Reduction Act’s (IRA) price negotiations, Astrazeneca plc is the latest to file a challenge. It’s the first non-U.S.-headquartered company to do so and, unlike the other challenges, Astrazeneca’s complaint focuses on the impact to the Orphan Drug Act (ODA). In a statement, the Cambridge, U.K.-based firm said the “drug price negotiation provisions of the IRA run headlong into the goals” of the ODA.
Boehringer Ingelheim GmbH is the latest company to dive into the legal fray surrounding the federal government’s plan to change drug costs. The drug price negotiation program established by the Inflation Reduction Act is “unlawful,” according to the company’s brief, because it violates the due process clause and the just-compensation portion of the U.S. constitution’s Fifth Amendment.
Nearly 13 years after Congress created a biosimilars path to bring competition to the U.S. biologics market, new rules of the road are coming into play, via the Inflation Reduction Act (IRA), that could change the course for biosimilars in the long haul – if the IRA’s prescription drug price negotiation mandate withstands numerous constitutional challenges.
Johnson & Johnson and its Janssen pharmaceutical companies added their name July 18 to the growing list of biopharma companies and organizations challenging the Inflation Reduction Act’s (IRA) mandated drug price negotiations.
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year.
The U.S. Inflation Reduction Act (IRA) may look like domestic affair, but the drug price controls it is bringing in are set to impact the biopharma sector across the globe.
The U.S. Inflation Reduction Act (IRA) may look like domestic affair, but the drug price controls it is bringing in are set to impact the biopharma sector across the globe.
With the passage of the Inflation Reduction Act in the U.S. in August 2022, biopharma company leaders have re-evaluated pipelines, sought legal advice, and discussed ways to mitigate the potential impacts the legislation will have on pricing therapies and extending their reach to new indications.
