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Medicare Seeks Input On Dispute Resolution, Civil Penalties For Rx Pricing Program

 
• By Cathy Kelly

Calculating a ‘fair price’ for new versions of already negotiated moiety is also one of several that CMS is requesting input on in its recently released initial guidance on the negotiation program.

Medicare Guidance Explains How Price Negotiation Will Work In First Year • Source: Shutterstock

While one section of the initial Centers for Medicare and Medicaid Services guidance on the drug price negotiation program is final, the agency is actively seeking comment, if quickly, on several other elements.

The 91-page guidance was released 15 March with a narrow 30-day window for public comments, which are due by 14 April. (Also see "Medicare Price Negotiations: Competitors’ Net Prices, Clinical Benefit Are ‘Starting Point’ For Initial Offer" - Pink Sheet, 16 March, 2023

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Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
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President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 
• By Francesca Bruce

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.