@RPMReportMike

Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business

 Washington DC
previsionpolicy.com
Joined March 2009
  • Tweets4.4K
  • Following240
  • Followers2.2K
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Michael McCaughan retweeted
Derrick@dgingeryAug 5
Watch the @FDA advisory committee space going forward. This issue could linger ... @PharmaPinkSheet @RPMReportMike: Compounding The Problem: Peptides And The US FDA Advisory Committee Process insights.citeline.com/pink-s…

Compounding The Problem: Peptides And The US FDA Advisory Committee Process

The FDA should hope the July FDA advisory committee review of peptide ingredients for compounding does not set a precedent for committee operations going forward.

insights.citeline.com
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Michael McCaughan retweeted
Derrick@dgingeryJun 4
Along with these, what controversial product does @RPMReportMike suggest get an advisory committee meeting in @PharmaPinkSheet? US FDA Advisory Committees Revisit Makary Controversies: Mflusiva And Tzield insights.citeline.com/pink-s…

US FDA Advisory Committees Revisit Makary Controversies: Mflusiva And Tzield

The US FDA is planning advisory committee meetings for two applications that were controversial under former Commissioner Martin Makary, but will they help reset the climate in the post-Makary era?

insights.citeline.com
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Michael McCaughan retweeted
BrainStorm@BrainstormCellMay 28
We are honored to welcome @PeterPitts, former @US_FDA Associate Commissioner, to BrainStorm's Board of Directors. His expertise will help support our mission to advance NurOwn® for people living with ALS. #NurOwn #Biotech #FDA #ALS Read more: bit.ly/4uD6Q0o
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Michael McCaughan retweeted
Ramsey Baghdadi@Ramsey_BaghdadiMay 15
Great read. Midterms still seems like safer bet.
Adam Cancryn@adamcancrynMay 15
Replying to @adamcancryn
Latest on the post-Makary turmoil across the Food and Drug Administration: cnn.com/2026/05/15/politics/…

Trump administration rushes to steady Kennedy’s HHS, with an eye on the midterms | CNN Politics

The Trump administration is racing to fill a widening leadership vacuum within the US Department of Health and Human Services, amid months of upheaval that have shaken Americans’ trust and stoked GOP...

cnn.com
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Not FDA/pharma related but important! youtube.com/watch?v=1iOLe8V3…

I Dare Not Dream: Innocent on North Carolina's Death Row

“I Dare Not Dream” tells the story of Stacey “Sabur” Tyler, an inno...

youtube.com
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Michael McCaughan retweeted
Derrick@dgingeryMay 5
An argument for the FDA to slow down ... @PharmaPinkSheet @RPMReportMike: Psychedelic Reviews: Why The US FDA May Be Heading For A Bad Trip insights.citeline.com/pink-s…

Psychedelic Reviews: Why The US FDA May Be Heading For A Bad Trip

US FDA Commissioner Martin Makary is promising hyper-fast reviews for three psychedelic mental health therapies, but the products are a class where the agency likely would be better served taking its...

insights.citeline.com
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Michael McCaughan retweeted
Derrick@dgingeryFeb 6
When will be see the impact of the upheaval? Six months? A year? Never? An interesting question ... @PharmaPinkSheet @RPMReportMike: A Strong Year For US FDA Approvals, But Warning Lights Flashing insights.citeline.com/pink-s…

A Strong Year For US FDA Approvals, But Warning Lights Flashing

The headlines showed a robust tally of new drug approvals from the US FDA in 2025, but cracks are beginning to show that could turn into fissures in the year ahead.

insights.citeline.com
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Michael McCaughan retweeted
Pink Sheet@PharmaPinkSheetJan 8
US FDA’s Richard Pazdur: Appreciating An Extraordinary Career — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4ky4k vist.ly/4ky4m

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citeline.com
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Gotta believe it already has a 100% inflation rebate.
Zach Brennan@ZacharyBrennan19 Dec 2025
Replying to @ZacharyBrennan
$BMY to provide Eliquis to Medicaid for free
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Michael McCaughan retweeted
David Greenberg@republicofspin4 Dec 2025
Named one of Amazon's best books of 2024, JOHN LEWIS is out in paperback and it makes a good Hanukkah/Xmas/Kwanzaa gift! Hardcover also on steep discount at Amazon. Happy to sign copies for you (just email me). LINK here: amazon.com/John-Lewis-Life..…
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I would also love to know if the prices quoted for Ozempic and Wegovy are the MFPs (price negotiation) as well as the MFNs....
Ian Spatz@rockcreekpolicy6 Nov 2025
Questions on GLP-1 coverage in Medicare and Medicaid: (1) will there be coverage conditions (e.g., comorbidities)? (2) Will Part D plans have to cover? (3) Will plans be able to negotiate further price concessions? (4) When would coverage begin? (5) Will states have to cover?
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Michael McCaughan retweeted
Derrick@dgingery24 Oct 2025
The two very different applications potentially getting the first @US_FDA decisions through the CNPV pathway. A @PharmaPinkSheet story from @RPMReportMike: Sanofi, Disc Will Be First To Test US FDA’s CNPV Pathway insights.citeline.com/pink-s…

Sanofi, Disc Will Be First To Test US FDA’s CNPV Pathway

Two applications with little in common could generate the US FDA’s first Commissioner’s National Priority Voucher action.

insights.citeline.com
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Michael McCaughan retweeted
Sarah Karlin-Smith@SarahKarlin21 Jul 2025
Worth revisiting the new CDER Director's role in this meeting. via @RPMReportMike insights.citeline.com/pink-s…

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

insights.citeline.com
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That would be a BFD, but not what FDA is doing here. These CRLs are I believe all already public.
Joe Gitchell
@jgitchell10 Jul 2025
Replying to @RPMReportMike
But ... I'm understanding this as release of CRLs before an approval, so not part of an SBA. For example, if I wanted to know what really happened with the @kenvue @Haleon_health @nicorette Quickmist mouth spray (+ve AdComm vote in 2019), could an FDA document tell me? 🤷‍♂️
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Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...
Joe Gitchell
@jgitchell10 Jul 2025
I bet @RPMReportMike has thoughts! This is a BFD, though we shall see what we see.
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Michael McCaughan retweeted
Joe Gitchell
@jgitchell10 Jul 2025
I bet @RPMReportMike has thoughts! This is a BFD, though we shall see what we see.
Rachel Cohrs Zhang
@rachelcohrs10 Jul 2025
News: The FDA plans to publish rejection letters describing why medicines aren't approved that companies have mostly kept hidden until now via @damiangarde + @SamHornblower bloomberg.com/news/articles/…

FDA to Share Rejection Letters Drugmakers Often Keep Secret

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep under wraps more easily available to investors and the public, a move with...

bloomberg.com
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Michael McCaughan retweeted
Derrick@dgingery9 Jul 2025
Interesting that this is happening in the absence of more agency detail on the program ... @PharmaPinkSheet @RPMReportMike: US FDA ‘Commissioner’s Voucher’ As Public Relations Tool insights.citeline.com//pink-…

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to...

insights.citeline.com
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Michael McCaughan retweeted
Derrick@dgingery29 May 2025
To say last week was "busy" for the @US_FDA press corps. is an understatement ... @PharmaPinkSheet @RPMReportMike: US FDA Meeting Drought Ends … With A Vengeance insights.citeline.com//pink-…

US FDA Meeting Drought Ends … With A Vengeance

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed...

insights.citeline.com
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Michael McCaughan retweeted
David Greenberg@republicofspin7 May 2025
Very proud and humbled to have JOHN LEWIS: A LIFE chosen as a finalist for the Pulitzer Prize in Biography. It was a privilege to write the life of this remarkable man, and it's been a joy to watch so many appreciative readers draw sustenance and hope from his story.
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Michael McCaughan retweeted
Derrick@dgingery25 Apr 2025
Despite saying @US_FDA should be apolitical, the agency has done some seemingly political things since the new commissioner's arrival, @RPMReportMike reports for @PharmaPinkSheet: Political Influence And The US FDA: A New Era? insights.citeline.com//pink-…

Political Influence And The US FDA: A New Era?

FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting...

insights.citeline.com
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