Medicare Cuts Could Come From HHS In 2019 With No IPAB In Sight

There is a 'fair' likelihood that the Independent Payment Advisory Board will be called on to propose spending cuts to Medicare, effective in 2019, the CMS chief actuary says. And if there is no IPAB in existence, HHS will assume responsibility.

Cuts to Medicare spending on drugs or other elements of the program may be triggered in 2017 and implemented in 2019 under the provisions in the Affordable Care Act establishing the Independent Payment Advisory Board, according to the chief actuary of the Centers for Medicare and Medicaid Services.

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Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
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During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
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The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
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Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.