Michael McCaughan (@RPMReportMike) header
Michael McCaughan (@RPMReportMike) profile picture

Michael McCaughan

@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
  • Following243
  • Followers2.2K
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Photo by Michael McCaughan (@RPMReportMike)Photo by Michael McCaughan (@RPMReportMike)Photo by Michael McCaughan (@RPMReportMike)Photo by Michael McCaughan (@RPMReportMike)Photo by Michael McCaughan (@RPMReportMike)
Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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

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.

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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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

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?

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Michael McCaughan retweeted
BrainStorm (@BrainstormCell) profile picture
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_Baghdadi) profile picture
Ramsey Baghdadi@Ramsey_BaghdadiMay 15
Great read. Midterms still seems like safer bet.
Adam Cancryn (@adamcancryn) profile pictureAdam 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

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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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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

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...

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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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

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.

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Michael McCaughan retweeted
Pink Sheet (@PharmaPinkSheet) profile picture
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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Our award-winning publications that go beyond the headlines, providing in-depth coverage and analysis of what matters most. Start your free trial today.

citeline.com
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Michael McCaughan retweeted
David Greenberg (@republicofspin) profile picture
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..…
Image from David Greenberg (@republicofspin)
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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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

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.

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Michael McCaughan retweeted
Sarah Karlin-Smith (@SarahKarlin) profile picture
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

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.

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Michael McCaughan retweeted
Joe Gitchell (@jgitchell) profile picture
Joe Gitchell
@jgitchell10 Jul 2025
I bet @RPMReportMike has thoughts! This is a BFD, though we shall see what we see.
Rachel Cohrs Zhang (@rachelcohrs) profile pictureRachel 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

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 (@dgingery) profile picture
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

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...

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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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

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...

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Michael McCaughan retweeted
David Greenberg (@republicofspin) profile picture
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.
Image from David Greenberg (@republicofspin)
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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
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?

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...

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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
Derrick@dgingery8 Apr 2025
Center director departures @US_FDA used to be relatively rare. Maybe not anymore. From @RPMReportMike and @PharmaPinkSheet: US FDA Center Directors Are Political Now insights.citeline.com//pink-…

US FDA Center Directors Are Political Now

The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new admini...

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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
Derrick@dgingery20 Mar 2025
Amazing what a compliment can get you, our @RPMReportMike writes for @PharmaPinkSheet: Oz’s Magic: US CMS Administrator Pick Praises Staff, Unlike Other Trump Health Care Nominees insights.citeline.com//pink-…

Oz’s Magic: US CMS Administrator Pick Praises Staff, Unlike Other Trump Health Care Nominees

US CMS Administrator nominee Mehmet Oz promises to inspire the agency he is set to lead and seems likely to succeed compared to other Trump Administration nominees.

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Join us and Prevision Policy for #BioPharmaCongress: Ready for a New Era on 4/7. Key topics include the future of accelerated approval and how #AI guidance will be implemented in the real world. Register today: biopharmacongress.com/
Image from Friends of Cancer Research (@CancerResrch)
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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
Derrick@dgingery4 Mar 2025
The compounding lawsuits could have a bigger impact than just compounding GLP-1s. The @US_FDA's drug shortage management could be at stake ... @RPMReportMike @PharmaPinkSheet: Compounding US FDA’s Problems: The High Stakes In GLP-1 Shortage Actions insights.citeline.com//pink-…
Compounding US FDA’s Problems: The High Stakes In GLP-1 Shortage Actions

Compounding US FDA’s Problems: The High Stakes In GLP-1 Shortage Actions

The explosion in pharmacy compounding as a source of GLP-1 weight loss medications has put the FDA in a tough spot to defend its drug shortage policies, but it is not the first time that compounding...

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Michael McCaughan retweeted
Derrick (@dgingery) profile picture
Derrick@dgingery28 Feb 2025
Not sure industry would like this switch in agency thinking ... @PharmaPinkSheet @RPMReportMike: Turning Back The Clock At The US FDA insights.citeline.com//pink-…

Turning Back The Clock At The US FDA

HHS Secretary Robert F. Kennedy Jr. is nostalgic for the 1960s. Will that include pushing the agency back to the pre-user-fee-era model of defining success based on blocking unsafe drugs, rather than...

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