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.<br><br>Get full access to Weight and Healthcare at weightandhealthcare.substack.com/subscribe

Novo Nordisk In Trouble For Not Reporting Serious Adverse Events to the FDA

Weight and Healthcare 

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**Podcast:** Weight and Healthcare

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Novo Nordisk is in trouble for not reporting serious adverse events to the FDA. This is the Weight and Healthcare newsletter. If you like what you're hearing, please consider subscribing and sharing at weightandhealthcare.com. Remember when I wrote about the FDA adverse 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, creating AstroTurf organizations that claim to be advocacy groups for higher weight people, but are, in fact, funded by Novo and other pharma and weight loss surgery groups and lobbying for their priorities, marketing their drug through Grand Rounds presentations,

creating PSAs and sponsored content using people who, you can't make this stuff up, play doctors on television, releasing a wildly misleading press release about a study prior to releasing the actual study so that it can't be fact-checked, co-opting the language and concept of anti-weight stigma activists in order to sell weight loss drugs, getting suspended by the Association of the British Pharmaceutical Industry for Unethical Practices,

getting caught in unethical practices by investigative journalists, and, very recently, engaging in misleading advertising. Now they're in trouble for failing to meet reporting requirements of post-marketing adverse drug experiences, or PADEs. Here's your too-long-didn't-listen summary. An FDA inspection found that Novo Nordisk had failed to report post-marketing adverse drug experiences, including serious adverse events and deaths, in the required timeframe, 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 were not followed. The FDA issued this letter after the initial FDA inspection and seven 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, quote,

Suggesting systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA, end quote, and noted that their failure to determine the root cause of the violations, quote, Raises concerns about your firm's ability to monitor the safety of your products, end quote. The letter states that the FDA has, quote, Let's take a deeper dive.

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 expe...

Novo Nordisk In Trouble For Not Reporting Serious Adverse Events to the FDA

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Novo Nordisk In Trouble For Not Reporting Serious Adverse Events to the FDA

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.