It’s difficult to keep track of all the ways in which Health and Human Services Secretary Robert F. Kennedy Jr. is undermining public health. When it comes to the Food and Drug Administration, his assault ranges from firing the administrative staff who support drug safety inspectors to deciding that artificial intelligence will fix everything.
One of the Trump administration’s myriad purges of federal workers took out the staff that coordinates travel for inspectors of foreign drug factories. While those eliminations might sound like small potatoes in the face of the terminations of top scientists and officials at the FDA, they make it much more difficult for those inspections to occur.
Most people who have ever had a normal job understand this. You can’t fire support staff without compromising the work of the staff they support. But since Kennedy, President Donald Trump, and former co-President Elon Musk have no idea how real jobs work, they’re probably unfamiliar with the concept. Still, these support staff cuts mean that managers, rather than support staff, are now forced to handle travel, budgets, visas, translators for FDA inspectors, and other tasks.
Guess what happens if FDA inspectors aren’t inspecting foreign drug factories that manufacture products for the United States market? You guessed it: Safety violations will go unnoticed and unaddressed. ProPublica documented that when FDA inspectors visited a Sun Pharma factory in India in 2022, they found metal shavings on equipment, contaminated drug vials, and unknown matter being mixed into drugs. Around the same time, a visit to an Intas Pharmaceuticals factory in India found manipulated testing records covering up the fact that things like glass were making their way into the drugs manufactured there.
The Centers for Disease Control and Prevention headquarters in Atlanta, shown in October 2013.
So it appears Americans are going to experience the joy of taking drugs tainted by ground glass and god knows what else. Seems bad! But maybe things are better stateside?
Nope. The Centers for Disease Control and Prevention are planning to use artificial intelligence in the drug approval process. How? Well, Kennedy isn’t so clear on that part. He says AI will be used to “look at the mega data that we have and be able to make really good decisions about interventions”—which is a word salad.
Kennedy’s toddler-level understanding of AI may also soon be imposed on the Vaccine Adverse Event Reporting System. VAERS is currently a database that allows scientists to track reports of alleged side effects, and to use those reports as a jumping-off point for further research about the safety of a vaccine. But during the COVID-19 pandemic, vaccine conspiracy theorists latched onto VAERS as a way to promote their anti-science beliefs.
Because anyone can report side effects about any vaccine to VAERS, that raw data is somewhat meaningless. It’s only after scientists review the data and determine whether the alleged effects are actually related to a vaccine that determinations can be made about safety. But since anyone can download VAERS data, anti-vaxxers ran to places like Fox News to report supposed vaccination-related deaths without acknowledging or understanding that those death reports had not been investigated or definitively linked to a vaccine.
Kennedy hasn’t been clear what AI would do with VAERS data. However, depressingly, the Verge is likely right that he will shovel the VAERS data into some AI system to review vaccine side effects.
This is a twofold problem. One, the administration’s deep love for AI as a replacement for people is unwarranted. Previous FDA dalliances with AI produced a bot that was supposed to help speed the review of medical devices. But the AI tool wasn’t connected to other FDA internal systems or external resources like medical journals. Well, who needs those, really? The tool also glitched out with basic tasks like uploading documents.
The notion that AI is ready for prime time and can undertake complex safety reviews is comical.
The second problem is Kennedy’s rabid anti-vaccine stance. He is frantically looking for side effects because his goal is to curb vaccinations. He does not appear interested in using VAERS to ensure vaccines remain safe and available, so he no doubt doesn’t really care if AI produces slipshod work as long as he can wave around “proof” that vaccines are bad.
Fewer safety inspections, fewer guardrails on drug approvals, and conspiracy-fueled attacks on vaccines. Turns out, “Make America Healthy Again” means just the opposite.
