The Latest Happenings at HHS

Over the past few months, the Department of Health and Human Services (HHS) and its subagencies have been quickly—and often destructively—changing the status-quo. HHS Secretary Robert F. Kennedy (RFK) Jr. has long voiced his skepticism toward the drug industry and vaccine approval process, with these concerns being integral to Secretary Kennedy’s Make America Healthy Again (MAHA) agenda. Between see-sawing drug approvals, changing vaccine recommendations by the Centers for Disease Control and Prevention (CDC), and shifting disclosure policies, it can be difficult for taxpayers and consumers to keep track of the many changes at the HHS. Fortunately, the Taxpayers Protection Alliance (TPA) has been closely tracking and analyzing these developments. Below is a recap of the many changes at the HHS.

CDC Vaccine Panel Alters Vaccine Recommendations

Recently, the Advisory Committee on Immunization Practices (ACIP)—a CDC vaccine panel—convened to reassess its vaccine recommendations. While the panel wisely rejected a motion that “state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccination,” the rest of its decisions had consumers and health experts scratching their heads. For example, it declined a more sweeping recommendation for COVID-19 vaccines, instead embracing a confusing concept called “shared clinical decision-making” (SCDM).

According to University of California law professor Dr. Dorit Reiss, SCDM “usually leads to less uptake, partly because nobody is sure what it requires.” This means that residents of states such as Hawaii, Minnesota, New Mexico, and Wisconsin are probably once again allowed to get boosters at pharmacies. But in states that don’t give pharmacists authority to administer vaccines based on ACIP recommendations, patients won’t be so lucky. And because the FDA recently opted to require prescriptions for COVID-19 vaccines as a default, access will be significantly compromised across the country.

Secretary Kennedy Mulls Vaccine Court Changes

As currently constituted, the National Vaccine Injury Compensation Program (VICP) provides payouts for patients injured by vaccines while allowing manufacturers a reprieve from costly lawsuits that could disrupt vaccine supply. Secretary Kennedy wants to upend that status-quo, proposing to swamp the VICP by adding costly and unfounded autism-related claims to the system.

The question over whether to consider autism as a “table injury”—a health condition found to be caused by vaccines and eligible for a VICP payout—is not a new one. In the early 2000s, VICP addressed more than 5,000 autism-related petitions by consolidating them into a handful of test cases for consideration. Years of study, testimony, and submitted evidence yielded a clear result: vaccines do not cause autism. As United States Court of Federal Claims Special Master Daniel T. Horner noted in more recent proceedings, petitioners in the test cases as well as follow-on individual cases argued separate theories of causation but invariably came up short in the evidence department. That’s not much of a surprise given that the link between autism and vaccines has been extensively studied and debunked by scientists.

Reversing this carefully-thought-out precedent would be exceptionally costly for taxpayers and consumers. As University of Pennsylvania legal scholar Peter Grossi notes, “the economic burden on the VICP of just one year of the most serious autism cases would likely total more than $30 billion—more than 100 times the program’s annual revenues. And because such claims could be submitted by those diagnosed within the last three years, the program could be faced with an immediate docket consisting of claims totaling nearly $100 billion.” This would almost certainly bankrupt the system, leading to the pre-VICP status quo of disruptive litigation that bankrupted vaccine manufacturers and disrupted supplies.

The Food and Drug Administration (FDA) Targets Drug Advertisements

On September 9, the White House issued a memorandum cracking down on direct-to-consumer (DTC) drug advertisements. The memo instructed that HHS “ensure transparency and accuracy” in DTC ads, including by “increasing the amount of information regarding any [usage] risks” and ensuring “truthful and non-misleading information” in ads.

The FDA responded by issuing a flurry of warning letters to producers claiming that their advertisements are misleading and must be changed. For example, the makers of Fasenra (an asthma medication) landed in hot water for showing “compelling before-and-after presentations imply[ing] an improvement in social and emotional functioning. Before Fasenra treatment, the woman is described and presented as bored, stuck at home, and ‘losing [her] groove.’ In contrast, after Fasenra treatment, she is portrayed as someone with an active social life, involving salsa dancing, that is captured on social media as a photo garnering numerous ‘likes.’” Because studies on Fasenra have allegedly not examined social or emotional well-being, the FDA is claiming that patients might get the wrong idea from salsa dancing scenes.

Here, the FDA is missing the forest for the trees. The ad is (reasonably) trying to convey that patients will likely feel better after taking the med and do activities they were previously unable to do. As a result of this crackdown, drugmakers will think twice before producing ads, leading to less information for patients on medications that can improve their lives.

White House, HHS, and FDA Push Dubious Tylenol-Autism Link

On September 22, the White House held a press conference in which President Trump and Secretary Kennedy alleged a link between Tylenol—a popular pain-relieving medication—and autism. But little information emerged about the research process that led to that conclusion. Indeed, even the FDA acknowledged in its letter to physicians on the topic that a causal relationship between Tylenol and autism has not been established and there has been conflicting information on the topic.

Meanwhile, the government refuses to answer questions about the “how” and “why” of its ongoing autism research.  On September 5, the Taxpayers Protection Alliance Foundation submitted a Freedom of Information Act (FOIA) request to HHS to get better insight on the agency’s autism research process. Unfortunately, the agency has yet to respond. This is not an isolated incident at the HHS. An April report in Politico noted that agency officials were shutting down FOIA offices and scaling back information response efforts. This not only raises legal questions but also enables government officials to act recklessly and politicize science. It’s time for a more transparent approach.

FDA Starts Telling Patients its Reasons for Drug Denials

For decades, the FDA has been notoriously tight-lipped about why it rejects drugs. The FDA has remained all-but-silent even when the agency rejects the advice of its advisory committees and refuses to approve life-saving drugs. Fortunately, this unwarranted secrecy is (seemingly) no more. On July 10, the FDA announced it was embracing “radical transparency” by publishing more than 200 complete response letters (CRLs), which typically specify why medications are rejected. On September 4, the agency announced it’s releasing even more CRLs, including doing it in real time (i.e., right after a drug gets rejected). These letters are already offering a glimpse into the often-bizarre decision-making plaguing America’s drug regulator.

For example, in 2023, the agency rejected a medication called Legubeti (to treat acetaminophen overdoses) because of “an unpleasant odor that may affect the tolerability of oral ingestion.” While the FDA ultimately approved the medication the following year, the odious regulatory delay very likely cost lives. Acetaminophen (e.g., Tylenol) overdoses result in about 500 deaths annually in the U.S., and delays over trivialities are a reckless exercise in regulatory foot-dragging. The well-known diabetes medication metformin remained on the market even though patients complained that it smells like “dead fish.” With that kind of precedent, surely smell and taste shouldn’t be an issue in approving other life-saving drugs.

Hopefully, the FDA continues this increased transparency and tells patients why they can’t have access to new therapies.

Conclusion

It’s been difficult to keep up with everything going on at the HHS and FDA. This recap offers but a small glimpse into these many changes. TPA will continue to fight for patient choice and government transparency as the MAHA movement continues to gain steam.