Robert F. Kennedy Jr., whom President-elect Trump has said will “go wild on health” in his administration, posted shortly before the election:
FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.
On the highest level, Kennedy seems to oppose the pharmaceutical business model, which requires patents and the exclusivity they provide to justify and support years of research and development work and billions of dollars in investments required for innovative drug development. He also seems to believe many, if not all, FDA positions and actions are motivated, at least in significant part, to protect the interests of the innovator drug industry.
More specifically, Kennedy’s often publicized criticism of the industry suggests he may use his influence to:
- permit the manufacture and distribution of medical products that have not gone through the FDA approval or clearance processes, such as compounded GLP-1s, stem cells and some medical devices
- permit marketing claims, including for some products that do not comply with all FDA regulations, that would disadvantage drug, device and food manufacturers that are compliant with FDA requirements
- prohibit the manufacturing of foods that use FDA approved dyes and additives
- permit the interstate shipment of raw milk
Following are suppositions about how Kennedy believes FDA has “aggressively” suppressed these products and actions, informing the abovementioned list.
First, Kennedy seems to disapprove of the drug approval standard or FDA’s long-standing implementation of it: The agency declined to approve a psychedelic, MDMA, for the treatment of PTSD, after questions were raised about the clinical trial data supporting the application and an advisory committee recommended against approval.
Second, it seems Kennedy does not believe FDA should enforce the drug approval requirement. For example, his citation of peptides may indicate his ire at FDA’s recent announcement that one approved GLP-1 drug was no longer in shortage, which could limit compounding pharmacies’ ability to make customized versions of it. With regard to stem cells, FDA has said that stem cells should be used under an investigational drug exemption (IND), and it has successfully taken some enforcement actions against doctors who have used unapproved stem cells without an IND.
Third, Kennedy seems to disapprove of FDA cautioning against the unapproved use of some medical products. For example, the FDA has cleared hyperbaric oxygen therapy devices as Class II medical devices for several uses but asserts that other uses (curing cancer, Lyme disease, autism and Alzheimer’s disease) are unproven. FDA has also cautioned against the off-label use of ivermectin and hydroxychloroquine to treat COVID-19 infection. Another example where Kennedy is likely to take issue is that under the Dietary Supplement Health and Education Act, FDA limits the disease claims that vitamins and nutraceuticals can make. These positions seem to indicate support for allowing more latitude for the promotion and use of products for uses not reviewed or approved by the FDA. Although FDA issued guidance in the previous Trump administration to allow both drug and device manufacturers to provide information about unapproved uses more freely than previously, it remains to be seen whether Kennedy believes drug and device manufacturers should be able to promote unapproved uses of their products more broadly.
Fourth, he objects to a long-standing regulation that bans the interstate shipment of raw milk. He may push to withdraw the regulation and may, alternatively or as an interim measure, exert his influence to direct FDA to issue guidance saying it will not enforce the regulation.
Fifth, Kennedy’s longstanding positions suggest he believes FDA suppresses “clean foods” (a term generally used to mean whole, unprocessed foods) because the agency objects to the use of unproven claims about such foods, or because the agency has approved the dyes and chemical additives or otherwise allowed the use of ingredients in processed and ultra-processed foods—foods that Kennedy believes contribute to chronic disease. For example, Kennedy may push the FDA to issue guidance allowing the promotion of “clean foods” using claims that are currently not permitted (e.g., healthier or safer than processed foods), or he may seek to withdraw the approvals of certain ingredients that currently may be used in food. The former may give producers of “clean foods” an opportunity for marketing against the producers of other foods, such as processed foods. The latter would require many food manufacturers to reformulate their foods, which would impose costs on the manufacturers and take time to implement. Typically, FDA provides a substantial amount of time for manufacturers to reformulate foods, but Kennedy could push for that timeline to be expedited. Requiring quicker reformulation would substantially increase the economic costs of the regulation (rather than decrease regulatory burden). Moreover, if the time frame were exceptionally short, some manufacturers might need to withdraw their products from the market while they reformulate.
President-elect Trump has indicated he will nominate Kennedy to be secretary of health and human services. If confirmed, Kennedy will have direct oversight over FDA. We will be assessing his other statements to understand what his nomination may mean for FDA and how it may oversee the industries it regulates.
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