During a House hearing on the FDA’s 2024 budget request, a Republican subcommittee chair said he was not too pleased with the idea of a $7.2 billion budget — an 8% increase over the 2023 enacted agency budget.
The $522 million increase includes $372 million in new budget authorities coupled with $150 million for new user fees.
Rep. Andy Harris, MD (R-Md.), chair of the Agriculture, Food and Drug Administration, Rural Development, and Related Agencies subcommittee, also pointed out that while the FDA’s budget authority has grown by 25% since 2018, oversight and monitoring of the agency’s resources have been lax.
“I intend to look deeper into how all existing resources are being used,” Harris said, especially given the structural overhaul of the agency’s food program. (In January, Califf announced that a new human food program would be established and would be overseen by a deputy commissioner, who would oversee 80% of the U.S. food supply, according to PBS.)
“As I stated last year, I believe that many of the problems faced in the FDA can be solved through strong leadership and not necessarily with more money, and I stand by that statement,” he added.
Rep. Rosa DeLauro (D-Conn.), ranking member of the full committee, noted that she’s been an advocate for creating a “single food agency” under the HHS umbrella for years, and saw the restructuring plan as a “step in the right direction.”
While some House Republicans’ proposals have suggested returning the agency’s spending to FY 2022 levels, doing so would be “detrimental” to all of the services the FDA provides, she added. “They would force a reduction in foreign and domestic inspections, impair the FDA labs’ ability to find the cause of foodborne illnesses, and devastate the workforce.”
“While not a perfect agency, the FDA’s programs must be fully funded to ensure the health and safety of the American people. Anything less puts people at risk,” she said.
Harris also slammed the agency for its facetious tweets warning against the use of ivermectin for COVID-19, and accused the agency of “playing… political favorites.”
In August 2021, the FDA tweeted a picture of what appeared to be a veterinarian and a horse in a split-screen photo, alongside a doctor assessing a patient. The tweet read: “You are not a horse. You are not a cow. Seriously y’all. Stop it.”
The tweet linked to an article entitled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” that was published on the agency’s website.
Harris argued that the tweet was “totally inappropriate,” given the widespread use of off-label medications broadly and the product’s “incredible safety record.”
“Now, it looks like it may not be effective for COVID, but physicians were prescribing it off-label, [and] it’s a very safe drug,” Harris said, noting that humans have taken “hundreds of millions of doses.”
Harris compared ivermectin to leuprolide, which treats prostate cancer and is used to treat gender dysphoria in teenage girls. The puberty blocker, which is also used off-label, “may cause lasting health problems,” said Harris, citing a 2017 STAT article.
Over 20,000 adverse events related to leuprolide have been reported to the FDA, 12,000 of which were considered serious, and 2,000 deaths have been reported, Harris told FDA Commissioner Robert Califf, MD, the hearing’s sole witness.
“Is FDA going to tweet about that or put that on the website?” he asked.
Harris asked whether the person who wrote the tweet still worked for the agency, but left little time for Califf to respond.
“That person should have been fired,” he said. “I would urge the FDA … instead of playing favorites, I would say, political favorites with off-label uses, the FDA should be much more serious if they want to be treated as a serious organization.”
Earlier in the hearing, Harris called attention to a recent Politico article that claimed the FDA knew that a major plant producing infant formula had found bacteria in the product months before a recall was issued. He also questioned the “atypical collaboration” between the agency and the drugmaker Biogen on the Alzheimer’s drug aducanumab (Aduhelm), and appeared critical of the agency’s decision to grant an emergency use authorization to “experimental COVID vaccines on 6-year-olds.”
DeLauro echoed criticism of the agency’s handling of the infant formula recalls, and said the FDA was “still dragging their feet when it comes to the health and safety of our babies.”
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