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Remember when I wrote about the FDA Averse Events Reporting System and how the drug companies are required to report adverse events? Novo Nordisk just got a warning from the FDA for…not doing that. This is part of a long list of Novo’s misdeeds including (but certainly not limited to):
Putting doctors on their payroll to promote their drugs to the media without disclosing their ties to Novo
Marketing their drug through Grand Rounds presentations
Getting caught in unethical practices by investigative journalists
And, very recently, engaging in misleading advertising
Now they are in trouble for failing to meet reporting requirements of Postmarketing Adverse Drug Experiences (PADEs).
Summary
An FDA inspection found that Novo Nordisk had failed to report postmarketing adverse drug experiences (PADEs) including serious adverse events and deaths, in the required time frame (and in some cases at all.) In some cases their written procedures were out of FDA compliance, in some cases their written procedures were in compliance but not followed. The FDA issued this letter after the initial FDA inspection and 7 pieces of follow-up correspondence from Novo Nordisk, because Novo’s responses failed to provide sufficient details to show that similar violations won’t happen in the future. The FDA characterized Novo’s violations and subsequent responses as “suggest[ing] systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA,” and noted that their failure to determine the root causes of the violations “raises concerns about your firm’s ability to monitor the safety of your products.” The letter states that the FDA has “serious concerns about the scope and impact of these violations on your entire product portfolio.”
Deeper Dive
Postmarketing adverse drug experience (PADE) reporting is critically important because drugs are approved by the FDA based on relatively short trials which cannot fully capture long-term adverse event profiles. Therefore drug companies are required to have clear plans to capture and report adverse drug experiences (ADEs) post-approval, and to follow through with those plans. The FDA “relies on complete, accurate and timely safety information to evaluate a product’s safety profile and uphold its mission to protect and promote public health.”
I am pointing this out to make it very clear that a failure to meet the FDA requirements to report PADEs is a threat to public health.
In a letter issued March 5, 2026, the FDA began by stating that an inspection of Novo Nordisk undertaken between January 13 and February 7, 2025 found “serious violations of PADE reporting requirements.”
Following the inspection Novo Nordisk was issued a Form 483 for PADE reporting violations. Per the form, “companies are encouraged to respond in writing with their corrective action plan and then implement that corrective action plan expeditiously.” Novo responded on April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026.
On March 5, 2026 the FDA issued a warning letter because, even after all that correspondence “it appears that you did not adhere to the applicable statutory requirements…”
The FDA took this opportunity to “emphasize” (their word) to Novo that
“As an application holder of products with active ingredients including semaglutide, liraglutide, nedosiran sodium, and estradiol, NNI is required to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA. You developed written procedures that failed to ensure that you, and your contractor acting on your behalf, complied with all applicable PADE regulations for the surveillance, receipt, evaluation, and reporting of ADEs.”
To be clear, Novo’s “Our Medicines” page lists 38 different medications so it’s not like they are new to this and it’s not like they don’t have a long history of regulatory violations.
While the FDA letter focused on semaglutide, liraglutide, nedosiran sodium, and estradiol, the letter made clear that the FDA has concerns about “the scope and impact of these violations on your entire product portfolio.”
Next the letter lists “examples of this failure” which “include but are not limited to”
Failing to develop required written procedures that ensured the Novo and the contractor acting of their behalf “reported all serious and unexpected ADEs to FDA within 15 calendar days.”
Specifically, the FDA letter notes that Novo’s written procedure for “Handling of Adverse Events and Other Safety Information” allowed Novo to avoid reporting Adverse Drug Experiences (ADEs) if the reporters specifically state that they believe the events to be unrelated or that a causal relationship can be excluded.
Novo made this exception up and the letter is clear that it is “inconsistent with FDA regulations.” The letter makes clear that based on Novo’s made up procedure their staff or contractor “cancelled or rejected serious and unexpected ADEs that were required to be reported.” They give an example of a liraglutide patient who had a stroke that went unreported.
The letter goes on to explain that Novo opened a deviation (DV0166369) in April 2024 after “discovering” that ADEs were not reported because their staff and contractors were inappropriately documenting them as “incidental” or “incidental and unrelated.” Novo claimed that the confusion was because their written procedures were consistent with regulations of countries outside the US.
Again, Novo is not a new player in the US drug game so I’m not super convinced. Also, this “we didn’t know” claim has appeared before, including when they were caught by the Association of the British Pharmaceutical Industry secretly funding a “training” that was, in effect, a marketing seminar for their drug. In that case the “we didn’t know” defense backfired spectacularly, to the tune of a public reprimand and multi-year suspension from the organization. In another example, Novo Nordisk was called about by watchdog group Danish Patients when the Danish Ob*sity Association created a campaign lobbying for government subsidies for weight loss drug Wegovy, without disclosing that 94% of their funding came from Novo Nordisk (if this sounds familiar, much like the Ob*sity Action Coalition here in the US, the Danish Ob*sity Association is Novo’s astroturf “patient advocacy” group in Denmark. They are repeating this model in countries all over the world. ) The Vice-Chair gave a presentation at a Novo Nordisk event giving her personal weight loss testimonial in volition of rules of the Danish Ethics Board for the Pharmaceutical Industry (ENLI). Novo responded that they didn’t know ENLI rules applied. So we see a pattern of Novo responding to serious ethical breaches with a claim that is barely a step above the patented Shaggy “It wasn’t me” defense. (With thanks to the brilliant Louise Adams for the information about the Danish ethics violation.)
Back to this latest FDA violation. The letter points out that Novo closed the deviation in December 2024 and that while they claimed in a written response that they had submitted the ADEs, they didn’t actually provide the information the FDA would need to verify (and I can’t imagine that the FDA is willing to take Novo Nordisk’s word for it!) Novo also failed to provide “sufficient information” as to how they would fix the problem moving forward.
The letter further explains that Novo’s correspondence fails to “provide sufficient details about how your updated procedures, guidance, and training materials will ensure future compliance with reporting serious and unexpected ADEs to FDA in a timely manner.”
But wait, there’s more…
The letter continues that Novo’s written procedures failed to ensure that they and their contracted call center “correctly received, reviewed, and processed ADE information” which ended up in a failure to submit ADEs as required. The letter points out that Novo and their contractors wrongly invalidated reports claiming that there were no patient identifiers but the FDA representatives looked at the source documents and found the valid patient identifiers. One of these involved the death of a semaglutide patient.
It turns out that this issue was identified with a contracted call center from May to October, 2023. Novo changed call centers, opened a deviation, and completed corrective and preventative action but continued to claim that cases lacked patient identifiers when the identifiers were actually available.
The FDA isn’t done though, they also point out that Novo’s written procedures stated that cases would enter “medical review” by calendar day 9 following the awareness date with medical review completed by calendar day 10. Except that didn’t happen, and cases languished in “medical review.” In one example a semaglutide patient who reported suicidal ideation entered “medical review” status on December 16, 2024 but the review wasn’t performed until February 3, 2025, and that was only after it was uncovered by the FDA inspection.
Novo also made up their own rule, against FDA requirements, that if the ADE was reported by a non-healthcare professional and consent was not obtained from the reporter then there was no need for follow-up. Here a reported death of a semaglutide patient was not reported. Under the same rule, Novo claimed that in death cases they would make two follow-up attempts to obtain relevant information but, in one example, a semaglutide patient became depressed and died by suicide and Novo made exactly zero documented attempts and, as of the date of the FDA’s letter, has STILL not submitted the case.
I think that this part of the letter is worth quoting in its entirety (emphasis mine):
While we acknowledge the corrective and preventive actions your firm has taken since our inspection, your response is inadequate because you did not provide sufficient details to determine whether your actions will effectively prevent similar violations in the future. Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA. In addition, your failure to identify and assess the root cause(s) of deficiencies discussed in this letter raises concerns about your firm’s ability to monitor the safety of your products, including through oversight of vendors with whom you contract to fulfill any of your ADE responsibilities. While this inspection focused on NNI’s compliance with PADE regulations for a sample of NNI’s products, including semaglutide, liraglutide, nedosiran sodium, and estradiol, based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio.
When we hear claims, including research findings, from Novo Nordisk (and the massive stable of doctors on their payroll who have agreed to represent them,) we have to decide if we want to take the word of a company that has to be told by the FDA that they can’t make up reasons to avoid reporting serious side effects and deaths associated with their drugs and then has to be told by the FDA that, when they are caught doing that, they actually have to fix it and not just pretend to.
Remember that this is regarding an inspection that started in January of 2025. As I reported in this piece, the adverse events and serious deaths for semaglutide are already quite high, and that’s before we realize that, because of Novo’s actions, we may never know how many ADEs have gone, and will continue to go, unreported.
This month’s online workshop is Movement in a Bigger Body with Leslie Jordan Garcia. This workshop is for anyone who wants to learn more about weight-inclusive movement/fitness with the understanding that nobody is obligated to participate, but every body should be welcome. There is a pay-what-you-can-afford option and all registrants get a video in case you can’t make it live. Details and Registration are here!
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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.
There was a time when the FDA did the reporting of adverse events and not the companies that sell the drug therapies. Getting the companies to “police” themselves was always going to be a bad for the consumers. (And while we are at it, companies should not be “legal persons”.)
I’m particularly angry at the company’s failure to report suicidal thoughts and acts, because I had the former symptom on a Novo Nordisk GLP-1 (not Ozempic). But the FDA in January “requested removal of suicidal behavior and ideation warning from” GLP-1 meds. So surprising that they found no correlation when the company is withholding reported cases.