The Food and Drug Administration (FDA) has a vast mission. This often leads to a vast deficit. The agency notes that “FDA-controlled products account for about 20 cents for every dollar spent by US consumers.” Given this heavily regulated footprint, patients and taxpayers are elevated when the FDA accepts the lighter regulatory sense of touch and decides to introduce flexibility in product approvals. But on the same scale, it is very frustrating when the FDA decides to slow down approval and lower the counterproductive rabbit hole. The FDA appears to be stuck in Jekyll and Hyde mode, with consumers paying prices repeatedly at higher costs and innovation. It has long been the past that regulators can cut red tape and allow patients to increase their choices without breaking the bank.
April 18th was a great day for the rare disease and patient patients in their families. Newly-cast FDA Commissioner Marty McCurry announced that the agency is pondering new approval routes for the treatment of rare diseases based on the “plausible mechanisms” of treatment, rather than a costly and time-consuming, randomized controlled clinical trial. This route is extremely important. This is because sponsors of rare disease therapies often struggle to find enough volunteers for clinical trials. In fact, about 80% of clinical trials (including general conditions) have been closed or delayed due to recruitment issues. Even if a “plausible mechanism” approach leads to several ineffective treatments reaching the market, patients ultimately have the hope that treatment for their condition is crossing the horizon.
But it takes a step forward, and a two step forward with the FDA. Just 10 days after Makary’s announcement, NBC News reported that the FDA is “requiring drug maker Novavax to conduct another clinical trial as part of the approval process for the Covid vaccine that will be available under emergency use permits from 2022 onwards.” The approval was based on a 30,000 randomized clinical trial conducted in 2021 and showed positive results in reducing severe illness in patients. McCurry justified the decision by bashing the pharmaceutical company. “Under this administration, we prioritize the gold standard of science. It doesn’t save millions of dollars from pharma companies,” the truth is that despite the virus-covid-family disease, it’s still fighting for thousands.
Vaccine approval is far from the only problem plaguing the FDA, and this falls within the Department of Health and Human Services (HHS). HHS Secretary Robert F. Kennedy Jr. (RFK Jr.) is on his mission to wrap red tape in every inch of the American food supply. On Secretary Kennedy’s list, there are few policy priorities that appear to be higher than the dyes coming out of food. The Health Secretary reportedly told food executives that they wanted these ingredients to be “before they took office,” and that they “have made clear their intention to take action, provided the industry is willing to become proactive in solutions.” The threat of “take action” is a horrifying statement from any bureaucrat. Some consumer watchdogs have raised alarms on links between dyes and behavioral disorders such as attention deficit/hyperactivity disorder, but the best research and meta-analyses to date have not found reliable links. Even in animal studies where food colored additives are administered to animals, the results are “small, inconsistent, and intrinsically dose-dependent” at doses that are much larger than those consumed by humans.
Anything that contains water is dangerous in significant quantities, but the discovery that sometimes animals can be injured with very high dye doses is a terrible argument for the prohibition.
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RFK Jr. uses his influence to promote new restrictions on the benefits of SNAP (actually food stamps managed outside of the Department of Agriculture’s HHS). Prohibiting the use of snaps to buy unhealthy foods may seem like a good idea. “From the 1980s, the federal government has urged people to eliminate fat and cholesterol and accumulate carbohydrates,” wrote A. Burton Hinkle in 2016 for a reason.
It is not surprising that the growth of this carbohydrate recommendation coincided with an explosion of obesity.
Overregulation and Mission Creep are disaster recipes at the FDA and HHS. Officials such as RFK Jr. and Makary Commissioners must abandon Jekyll and Hyde’s approaches to governance and commit to sworn regulatory reform. The patient deserves a break from endless red tape.
Ross Marchand is a senior researcher at the Taxpayer Protection Union.
