FDA commissioner promoted off-label COVID-19 vaccine use despite ban

The U.S. Food and Drug Administration (FDA) is meant to protect the health of Americans, but what happens when the person in charge is taking part in the exact type of behavior they prohibit others from engaging in?

That’s the question some people are asking about FDA Commissioner Dr. Robert Califf, who seems surprisingly eager to promote pharmaceuticals for off-label use despite the practice being banned.

During his first stint serving as the FDA commissioner under Barack Obama’s presidency, Dr. Califf even drafted a proposal that would see pharmaceutical firms given permission to advertise their drugs for off-label use. This is something that the FDA has long prohibited, and he received quite a bit of pushback for the proposal.

For example, Senator Ed Markey sent him a letter about the off-label use of deadly opioids, warning: “The FDA must not become complicit in the growing prescription fentanyl problem this country is combating.”

In 2009, pharmaceutical giant Pfizer paid $2.3 billion for illegally marketing more than a dozen of its drugs off label. They were investigated by several federal agencies, one of which was the FDA Office of Criminal Investigations.

This was a big issue at the time, and it’s something that hasn’t gone away yet. Dangerous (and often deadly) outcomes of off-label drug use still make headlines. Even the New York Times mentioned Dr. Califf’s push for off-label promotion in his previous stint as FDA commissioner when President Biden appointed him to the role yet again in 2021.

“[T]he proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration, according to a person familiar with it,” the paper noted.

X post by Califf promotes use of COVID-19 vaccines to prevent long COVID in children

Now that this criticism has died down a bit, he’s at it again, this time pushing for the off-label use of COVID-19 vaccines as a way to protect children from long COVID-19. He posted about this on X several months ago, sharing an article from the journal Nature about how the vaccines can somehow accomplish this.

Even the FDA has admitted this is not an authorized use. An FDA official told journalist Paul Thacker in a letter: “The FDA-approved and authorized coronavirus vaccines are indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccines are not approved or authorized as a treatment for long COVID.”

They reiterated in a follow-up email that the vaccines have not been approved or authorized for preventing long COVID.

However, the article Califf linked to in Nature did indeed make this claim, and the fact that he shared it will have been interpreted by many as an endorsement of it. But the study was a small, observational one that had never undergone peer review.

It also contained a number of quotes from pediatric infectious disease specialist Dr. Jessica Snowden. One thing that the Nature article conveniently forgot to mention when they published it is the fact that Dr. Snowden received money from Pfizer for providing marketing talks about their COVID-19 jab and she sits on their advisory board. (This fact was added in a correction to the story, but not until much later.)

The study was problematic in many ways, especially the fact that it depended on self-reports of long COVID rather than an official diagnosis from a medical professional.

Dr. Califf’s questionable stance is back in the spotlight after he recently gave a speech about the threat of “medical misinformation.” As you might have guessed, he was referring, at least in part, to COVID-19 vaccines. He must have forgotten that he is a part of the problem.

Sources for this article include:

DisinformationChronicle.Substack.com

X.com