OPDP Resources

Instantly search all OPDP/DDMAC enforcement letters since 1997 with curated filters and smart summaries.

[Regulatory Affairs Professionals Society @RAPSorg]

The Journal of Regulatory Affairs is coming in 2026! We invite regulatory professionals and experts to consider contributing to this quality, evidence-based journal: https://t.co/M4fqHk4Pdk

[OPDP Resources @OPDPresources]

@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

[OPDP Resources @OPDPresources]

@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.

[John Kamp @rxvoice]

Trump signs memo to crack down on direct-to-consumer pharma ads https://t.co/r0Esg5dnZJ

[PharmedOut @Pharmed_Out]

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?" https://t.co/EqFK0BxdoL

[Alexander Gaffney @AlecGaffney]

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.

[Nico Fiorentino @nico_fiorentino]

OPDP issues Warning Letter to Sprout Pharmaceuticals for CEO's misleading Addyi Instagram post, which completely omits risk information.

Letter: https://t.co/7xWspcBP1u

[Alexander Gaffney @AlecGaffney]

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?

https://t.co/NpWcAIOVnH

[pharmalot @pharmalot]

Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce.. https://t.co/2dSH6jMUVx #pharma #FDA #RFKJr #television #advertising $NVO $HIMS

[Robert Wittenberg @PharmerRob]

#FDA #OPDP issues Warning Letter to Sarfez's SOAANZ: webpages, HCP pamphlet & exhibit panel - make false/ misleading claims and representations about the efficacy & risks. https://t.co/PEv5ISVCzG

[Robert Wittenberg @PharmerRob]

#FDA #OPDP letters Mayne Pharma's NEXTSTELLIS' speaker deck which makes false/misleading claims about the risks. Letter: https://t.co/pbda76AGmA. Material: https://t.co/o6BplCqcuf

[Zach Brennan @ZacharyBrennan]

BREAKING: @VPrasadMDMPH named CBER director, per internal email

[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.

[Zach Brennan @ZacharyBrennan]

FDA cuts hit lawyers/policy folks in drug ad review office (OPDP), as Kennedy has pledged to eliminate ads - https://t.co/rxBC0KwrGw

[Matthew Herper @matthewherper]

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.”

https://t.co/BMrVUhlqvK

[Zach Brennan @ZacharyBrennan]

FDA review departments largely spared from Musk-led cuts - https://t.co/qG0BBjfxUm

[steve usdin @steveusdin1]

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: https://t.co/Akfjgdstlu

[Nico Fiorentino @nico_fiorentino]

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.
https://t.co/kzxuwbnoRr

[STAT @statnews]

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. https://t.co/7r2CESi1Zb

[Robert Wittenberg @PharmerRob]

#FDA #OPDP letters Merz's XEOMIN - social media post, for false/misleading benefit and risk presentations.
Letter: https://t.co/X977MdLNxG; Material: https://t.co/SelPTATaxu