Alexander Gaffney
@AlecGaffney
VP, Regulatory Policy & Intelligence @Politico's @AgencyIQ. Tweeting about @US_FDA's regulation of #Pharma, #MedicalDevice, #Biotech. Signal: AlecGaffney.01
Well, it's #healthpolicyvalentines day, which means it's time to repost THE GREATEST FDA WARNING LETTER EVER. Ahem: Roses are red, Violets are blue, Your product is made with "Love," yes, a ton, But that's a labeling violation under 21 CFR 101.4(a)(1) fda.gov/ICECI/Enforcem…
Scoop: Rep. Morgan Griffith (R-Va.) is in line to be announced Thursday as the next chair of the House Energy and Commerce Health Subcommittee. Rep. Buddy Carter is stepping down as the top GOP member on the subcommittee to focus on his Senate campaign. subscriber.politicopro.com/article/2025/0…
NEW: @US_FDA alum Mike Davis to rejoin agency as deputy director of the drug center. He previously worked in CDER's psychiatry division and most recently worked at a nonprofit developing psychedelic drugs for depression subscriber.politicopro.com/article/2025/0…
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/…
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.
This didn't get a lot of attention on Friday, but it's a big deal. FDA's top drug advertising oversight officials - the leaders of its Office of Prescription Drug Promotion - just left.
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.
CNN's @owermohle has a new report out today detailing how FDA's new Elsa AI tool is quite unrealiable, undercutting claims about how it will be used to make FDA more efficient: cnn.com/2025/07/23/pol…
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.
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.
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.
Today, the FDA published more than 200 decision letters, known as complete response letters or CRLs. CRLs are issued directly to product sponsors when the FDA completes its review cycle and determines that it cannot grant an approval of an application in its current form. By…
NEW: Long-time FDA staffer Annie Saha is going to be leading AI policy at the drug division. For pros: subscriber.politicopro.com/article/2025/0…
A combo announcement from Rick Pazdur and Vinay Prasad. Never thought I would see the day...
When we can minimize the burden on the healthcare system, while at the same time ensuring that benefits outweigh risks, we will! The FDA has taken a big step in removing barriers impeding the delivery of cures by removing the REMS requirement for BCMA- and CD19-directed…
Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say My latest — endpoints.news/sources-fda-ch…
Tala Fakhouri spoke at numerous sessions at the DIA annual conference this week and did not give any indications she was leaving. Another tough loss for CDER.
Updated this list again. In addition to the top drug regulator Jacqueline Corrigan-Curay and top gene therapy regulator Nicole Verdun, the drug center's top AI policy expert, Tala Fakhouri, is leaving this week. statnews.com/2025/04/03/fda…
What a week for FDA news...
Former Amarin CEO Karim Mikhail has joined FDA as a senior advisory to Commissioner Makary and is a candidate to serve as CDER Director buff.ly/xYHFIuf
Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her deputy Rachael Anatol have been placed on administrative leave and… trib.al/zMFHbah
FDA's budget documents were just published, which include this extraordinary statement which appears to validate my user fee trigger analysis:
SCOOP: Multiple former senior regulatory policy officials at FDA have expressed major concerns that FDA's user fee programs are at impending risk of collapse due to layoffs which threaten to trigger a legal provision banning the collection of any fees. home.agencyiq.com/article/000001…
Even if Covid-19 vaccine manufacturers wind up getting FDA licensure for new strains, it sure sounds like pediatric indications are going to be a longshot based on Makary's viewpoint here.
Speaking on Fox News last night, HHS Secretary Kennedy says that the MAHA Commission's report is expected to be published next week. AgencyIQ has written about the potential impact of this report on FDA regulation: agencyiq.com/blog/trump-est…