Instantly search all OPDP/DDMAC enforcement letters since 1997 with curated filters and smart summaries. https://xitter.gq/t.co/7kZY1ILJPp
Joined December 2012
- Tweets4K
- Following64
- Followers491
- Likes200
OPDP Resources retweeted
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
OPDP Resources retweeted
Trump signs memo to crack down on direct-to-consumer pharma ads cnb.cx/3VGmicl
OPDP Resources retweeted
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/…
OPDP Resources retweeted
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.
OPDP Resources retweeted
OPDP issues Warning Letter to Sprout Pharmaceuticals for CEO's misleading Addyi Instagram post, which completely omits risk information.
Letter: fda.gov/inspections-complian…
OPDP Resources retweeted
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/…
OPDP Resources retweeted
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
OPDP Resources retweeted
#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-complian…
OPDP Resources retweeted
#FDA #OPDP letters Mayne Pharma's NEXTSTELLIS' speaker deck which makes false/misleading claims about the risks. Letter: fda.gov/media/186470/downloa…. Material: fda.gov/media/186471/downloa…
OPDP Resources retweeted
BREAKING: @VPrasadMDMPH named CBER director, per internal email
OPDP Resources retweeted
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.
OPDP Resources retweeted
FDA cuts hit lawyers/policy folks in drug ad review office (OPDP), as Kennedy has pledged to eliminate ads - endpts.com/fda-cuts-hit-drug…
OPDP Resources retweeted
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-…
OPDP Resources retweeted
FDA review departments largely spared from Musk-led cuts - endpts.com/fda-review-depart…
OPDP Resources retweeted
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/65524…
OPDP Resources retweeted
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/downloa…
OPDP Resources retweeted
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
OPDP Resources retweeted
#FDA #OPDP letters Merz's XEOMIN - social media post, for false/misleading benefit and risk presentations.
Letter: fda.gov/media/183512/downloa…; Material: fda.gov/media/183513/downloa…
OPDP Resources retweeted
Senators probe whether Pfizer, Lilly DTC platforms create 'potential for inappropriate prescribing' fiercepharma.com/marketing/p…
