Trump 2.0 spells global change in pharmaceutical industry

Trump has promised to ‘Make America Healthy Again’, but many questions remain unanswered. Credit: Bloomberg / Contributor / Getty Images

Having promised to “Make America Healthy Again”, the administration in Trump’s second presidency looks set to shake up the health sector – both domestically and internationally. Regulatory bodies, including the globally relied-upon US Food and  Drug Administration (FDA), can expect to see an overhaul while America’s involvement in the World Health Organization (WHO) is set to shift.  

Trump’s staff nominations such as the selection of Robert F Kennedy Jr (RFK) as Secretary of the Department of Health and Human Services (HHS), and Dr Mehmet Oz as the administrator for the Centres for Medicare and Medicaid Services (CMS), are early indicators of the US’ possible trajectory. Additionally, Dr Marty Makary has been nominated to head up the FDA.

Both RFK Jr and Trump gave various clues along the campaign trail on the incoming administration’s likely health priorities. Promises have included pledges to “clean up corruption in our government health agencies” and to “put an end to the revolving” door between industry and government.

There has been heavy speculation around the future of the FDA given the potential incoming HHS secretary. In a post shared last month, before being nominated to lead the HHS, RFK Jr said: “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.”

Although his claims are unfounded – the FDA’s “suppression” of “sunshine” being a particularly bizarre suggestion – RFK Jr’s statement nevertheless indicates a serious shift in the usual regulatory processes of the FDA. It’s part of his wider depiction of pharmaceuticals as a “corrupt” industry that relies on the ill-health of American citizens. He said in October that “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”.

Responding to Pharmaceutical Technology’s queries on the potential impact of RFK Jr and the incoming administration, an FDA spokesperson said that “throughout its more than 115-year history, the FDA has continually upheld its mission to protect and promote public health across numerous administrations. The FDA is regarded globally as the gold standard public health regulatory agency and its more than 20,000 career staff include leading experts in their fields. The agency remains guided by science and the law for products within its oversight”.

However, if RFK Jr does intend to dismantle the current structures of the FDA and other health regulatory bodies, it could constitute a talent problem. Treehill Partners CEO Ali Pashazadeh tells Pharmaceutical Technology: “If there is a major shakeup of the FDA, how much of the human capital and the talent and experience there will end up walking out?”

A mass exodus has global implications too: over half of the 291,000 FDA-registered manufacturing and handling facilities are spread over more than 150 countries, and the regulatory body is responsible for the development of internationally harmonised standards and standards convergence.

Pashazadeh says a change in regulatory personnel under Trump could also slow pharmaceutical investments, at least in the short term:  “Until we know where the chips are falling, this probably isn’t the right time to put capital down, because you’re not sure what’s going to be in and what’s going to be out.”

On an international level, Trump’s business-oriented policies could see the US health agenda become one of deregulation; if the administration wants to flood global markets with American-produced drugs, there could be a loosening of requirements for new drug market authorisation.

Richard Sullivan, professor of cancer and global health at King’s College London, says countries in Europe, and others such as Canada and Australia are probably looking at what deregulation means for biopharmaceuticals: “If that means even more drugs are making it through with even less and less evidence as to their benefit or their toxicity, we’re in trouble.”

Although not a regulatory body, WHO is responsible for coordinating the expansion of universal health coverage and managing international responses to health concerns.

In May 2020, Trump notified the UN and Congress of his formal move to withdraw in July 2020, but his subsequent election loss saw him reluctantly leave the White House before the year-long process was completed. 

Sullivan says: “If [the Trump administration] are serious about withdrawing from WHO then they will and that will leave a massive hole of $600M to $700m.”

Losing the US on the global health stage will have wider financial ramifications: in 2022, the US was the largest donor to global health, providing $15.08bn in foreign health assistance in 2022. This put the US $11bn ahead of the second biggest donor: Germany, which provided $4.4bn.

Vaccination programmes are worried – particularly following the appointment of RFK Jr – that essential groups, including Gavi, the Vaccine Alliance, could face a potential loss of funding.

RFK set up the Children’s Health Defense in 2016, an anti-vaccination group with a mission of “ending childhood health epidemics by eliminating toxic exposure”, which has wrongly linked autism to thimerosal (a preservative in vaccines). The group celebrated RFK’s appointment on X saying, “We have complete confidence that he will fulfil the work he started at CHD to improve the lives of millions of children.”

Dr Nathalie Macdermott, NIHR clinical lecturer in the Department of Women and Child Health at King’s College London, says: “Childhood vaccination programs are one of the greatest public health achievements in our history, and the main reason the life expectancy of the human population is substantially increased since the pre-vaccination era. It is also the primary reason for the substantially reduced mortality rates globally in children under five years old.”

Despite concerns of medical professionals across the world, other global systems could also lose funding. The US has contributed $26.31bn so far to The Global Fund to Fight AIDS, Tuberculosis and Malaria. Biden’s fiscal year 2023 budget included “a $2bn contribution for the Global Fund’s Seventh Replenishment, for an intended pledge of $6bn over three years”. The future of the financial commitment from the US is now unclear.

New investors will keep a close eye on developments in the US, and it seems likely that many may adopt a ‘wait and see’ attitude, at least for now. An immediate impact however has been seen with vaccine manufacturers.

mRNA vaccine producer Moderna saw shares fall 7.34%– its lowest level since April 2020–between 14 and 15 November, around RFK Jr appointment. Moderna’s share price has returned to its previous value but remains significantly below pre-election levels. 

This story is echoed across vaccine producers. However, Pashazadeh says RFK Jr could bring “a fresh look at drug development and the healthcare market is very much overdue”. He notes that biotech investments have slowed down and the IPO market has been “patchy” signalling a need for bigger deals allowing investor flow. Perhaps then, the introduction of a new administration under Trump will enable an overdue review of existing health and pharmaceutical structures, and a shakeup could shake out old problems.

However, Sullivan sees more reason for concern. Regarding RFK Jr, he says: “We’re already in a world where disinformation in health and misinformation health is being weaponised in different ways. We’ve seen what the effect can be. Covid-19 was like a sort of transit ischemic attack. It was a warning to everybody of what this kind of thing can do, and from an even domestic purpose, the leadership required for health needs to be extremely au fait with what is going on.”