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The Journal of Regulatory Affairs is coming in 2026! We invite regulatory professionals and experts to consider contributing to this quality, evidence-based journal: hubs.la/Q03Tx_KF0
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OPDP Resources
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OPDP Resources
@OPDPresources
Instantly search all OPDP/DDMAC enforcement letters since 1997 with curated filters and smart summaries. https://t.co/7kZY1ILJPp
Katılım Aralık 2012
65 Takip Edilen492 Takipçiler
@AlecGaffney In my opinion, these are the kinds of comments a company might receive as part of an advisory review, but until last week’s shift in approach, would not typically have shown up in enforcement action
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I'm reading through every single one of the letters FDA sent to pharmaceutical companies last week regarding their drug ads, and while some of them are absolutely warranted, some of these letters are so absurd as to be talking points for government overreach.
Two examples:
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@reshmagar @ZacharyBrennan It usually takes 1-2 weeks for FDA to post these types of letters on their website after they are sent. I have heard anecdotally that companies did receive them yesterday.
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@ZacharyBrennan Any idea where the 100 cease and desist letters to companies with deceptive ads are? fda.gov/news-events/pr…
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Total nothingburger: the entire office that oversees prescription drug promotion at FDA was obliterated by DOGE.
Dr. Marty Makary@DrMakaryFDA
Today we’re taking long-overdue action to rein in pharmaceutical ads. For too long, misleading ads have distorted the doctor-patient relationship and driven costly, inappropriate care. Our actions will encompass online pharmacies promoting drugs with no mention of side effects, and paid social media influencers advertising drugs.
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Trump signs memo to crack down on direct-to-consumer pharma ads cnb.cx/3VGmicl
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Dick Durbin (D-IL) spearheaded a Direct-To-Consumer Telehealth Platform exposé of Big Pharma-telehealth partnerships that essentially sell drugs directly to consumers. Read “Big Pharma’s New Sales Scheme: Expanding Patient Access or a Virtual Pill Mill?" durbin.senate.gov/imo/media/doc/…
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So a need to amend the below: After digging in, it appears that most (all?) of these were previously available within the agency's Drugs@FDA database.
Further, this is *only* for since-approved drugs - not products that were never approved.
So not a massive deal.
Alexander Gaffney@AlecGaffney
A massive, massive deal. Industry, watchdogs, lawyers and media have been wanting access to these for years. I'm not sure how FDA's lawyers suddenly decided that they had the legal authority to release these, but it's going to be hard to put the genie back in the bottle.
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OPDP issues Warning Letter to Sprout Pharmaceuticals for CEO's misleading Addyi Instagram post, which completely omits risk information.
Letter: fda.gov/inspections-co…
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This scoop is finally getting some attention from Congress. Sen. Durbin just wrote to FDA Commissioner Makary asking a few key questions, including: Who is even in charge of overseeing drug advertising right now?
durbin.senate.gov/imo/media/doc/…
Alexander Gaffney@AlecGaffney
Just published a rather significant scoop for readers of AgencyIQ's "FDA Today" newsletter: The top leaders of FDA's drug advertising division, known as OPDP, are stepping down from the agency. Catherine Gray and Mark Askine informed FDA staff yesterday that they are leaving.
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Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce.. statnews.com/pharmalot/2025… #pharma #FDA #RFKJr #television #advertising $NVO $HIMS
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#FDA #OPDP issues Warning Letter to Sarfez's SOAANZ: webpages, HCP pamphlet & exhibit panel - make false/ misleading claims and representations about the efficacy & risks. fda.gov/inspections-co…
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#FDA #OPDP letters Mayne Pharma's NEXTSTELLIS' speaker deck which makes false/misleading claims about the risks. Letter: fda.gov/media/186470/d…. Material: fda.gov/media/186471/d…
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BREAKING: @VPrasadMDMPH named CBER director, per internal email
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OPDP Resources retweetledi
Just published a rather significant scoop for readers of AgencyIQ's "FDA Today" newsletter:
The top leaders of FDA's drug advertising division, known as OPDP, are stepping down from the agency.
Catherine Gray and Mark Askine informed FDA staff yesterday that they are leaving.
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FDA cuts hit lawyers/policy folks in drug ad review office (OPDP), as Kennedy has pledged to eliminate ads - endpts.com/fda-cuts-hit-d…
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The entire STAT staff is updating this story about layoffs at HHS. There will be a lot of info.
But the short version is this: a lot of the people who would keep drugs safe and effective, to protect patients in trials, and to fight bird flu and future pandemics are gone -- even though it seems the scientists in charge of directly reviewing new medicines are mostly protected at FDA.
Per Robert Califf: "[The FDA] as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed.”
statnews.com/2025/04/01/hhs…
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FDA review departments largely spared from Musk-led cuts - endpts.com/fda-review-dep…
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A cry for help from FDA rare disease reviewers. Firings, politicization, denigration of civil servants and an impending back-to-office will cause exodus of experienced staff, lower quality, slower product reviews. Open access story w/free registration: biocentury.com/article/655243
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FDA’s 1st 2025 untitled letter flags Dexcel’s Hemady exhibit booth panel for omitting risks & misrepresenting adherence data in multiple myeloma promo. Also received Bad Ad complaint.
fda.gov/media/185653/d…
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Former FDA Commissioner Scott Gottlieb, who served in the first Trump administration, is raising concerns with Republicans about RFK Jr's. nomination to lead HHS. trib.al/v49UFuY
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#FDA #OPDP letters Merz's XEOMIN - social media post, for false/misleading benefit and risk presentations.
Letter: fda.gov/media/183512/d…; Material: fda.gov/media/183513/d…
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