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OPDP Resources

@OPDPresources

Instantly search all OPDP/DDMAC enforcement letters since 1997 with curated filters and smart summaries. https://xitter.gq/t.co/7kZY1ILJPp

opdpresources.com
Joined December 2012
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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 retweeted
John Kamp (@rxvoice) profile picture
John Kamp@rxvoice9 Sep 2025
Trump signs memo to crack down on direct-to-consumer pharma ads cnb.cx/3VGmicl
Trump signs memo to crack down on direct-to-consumer pharma ads

Trump signs memo to crack down on direct-to-consumer pharma ads

The Trump administration plans to ensure transparency and accuracy in drug ads, including by increasing the amount of information related to any product risks.

cnbc.com
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PharmedOut (@Pharmed_Out) profile picture
PharmedOut@Pharmed_Out18 Jul 2025
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/…
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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) profile pictureAlexander Gaffney
@AlecGaffney10 Jul 2025
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-complian…
Image from Nico Fiorentino (@nico_fiorentino)
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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/…
Alexander Gaffney (@AlecGaffney) profile pictureAlexander Gaffney
@AlecGaffney18 Apr 2025
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.
Image from Alexander Gaffney (@AlecGaffney)
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OPDP Resources retweeted
pharmalot (@pharmalot) profile picture
pharmalot@pharmalot27 May 2025
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
Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce

Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce

A U.S. senator is asking the FDA how it will enforce regulations on pharmaceutical advertising after it let go of numerous employees from the office that oversees the issue.

statnews.com
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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-complian…
Sarfez Pharmaceuticals, Inc. - 708901 - 04/25/2025

Sarfez Pharmaceuticals, Inc. - 708901 - 04/25/2025

False & Misleading Claims/Misbranded

fda.gov
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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/downloa…. Material: fda.gov/media/186471/downloa…
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Zach Brennan (@ZacharyBrennan) profile picture
Zach Brennan@ZacharyBrennan6 May 2025
BREAKING: @VPrasadMDMPH named CBER director, per internal email
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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.
Image from Alexander Gaffney (@AlecGaffney)
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Zach Brennan (@ZacharyBrennan) profile picture
Zach Brennan@ZacharyBrennan1 Apr 2025
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…
RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them

RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them

HHS Secretary Robert F. Kennedy Jr. has made clear that he would like to ban direct-to-consumer drug advertisements on television and elsewhere. Instead, on Tuesday, he got rid of many of the FDA...

endpoints.news
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FDA review departments largely spared from Musk-led cuts - endpts.com/fda-review-depart…
FDA’s medical review departments remain untouched (for now) by Musk’s cuts

FDA’s medical review departments remain untouched (for now) by Musk’s cuts

Trump admin's FDA medical product review units remain protected from cuts, while Marty Makary awaits confirmation as commissioner. HHS offers buyouts but exempts FDA drug reviewers.

endpoints.news
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OPDP Resources retweeted
steve usdin (@steveusdin1) profile picture
steve usdin
@steveusdin14 Mar 2025
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…
Turmoil at FDA puts rare disease review capacity at risk

Turmoil at FDA puts rare disease review capacity at risk

A relentless six-week assault on the civil service, with more upheaval planned, has set off a “five-alarm fire for rare disease,” an FDA revi...

biocentury.com
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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/downloa…
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STAT (@statnews) profile picture
STAT
@statnews29 Nov 2024
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
Former Trump FDA chief is seeking to undermine RFK Jr.’s Senate confirmation

Former Trump FDA chief is seeking to undermine RFK Jr.’s Senate confirmation

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.

statnews.com
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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/downloa…; Material: fda.gov/media/183513/downloa…
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Senators probe whether Pfizer, Lilly DTC platforms create 'potential for inappropriate prescribing' fiercepharma.com/marketing/p…
Senators probe whether Pfizer, Lilly DTC platforms create 'potential for inappropriate prescribing'

Senators probe whether Pfizer, Lilly DTC platforms create 'potential for inappropriate prescribing'

A group of U.S. | A group of U.S. senators are digging into the direct-to-consumer telehealth platforms launched by Eli Lilly and Pfizer this year, in search of any indication that the services could...

fiercepharma.com
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OPDP Resources retweeted
sophie (@netcapgirl) profile picture
sophie
@netcapgirl30 Sep 2024
unmuting at the end of a call just to say “nothing from my end, thanks”
Image from sophie (@netcapgirl)
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Pharma, device groups ask for more leeway to address misinformation. bit.ly/4d7J6I9

News & Insights Search

raps.org
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