The Trump administration’s policy agenda, the approach of U.S. health secretary Robert F. Kennedy Jr., and the work of the Department of Government Efficiency (DOGE), are upending the way pharmaceutical products, medical devices and healthcare innovations are evaluated and approved in the United States.
Several of President Trump’s more than 150 executive orders (EOs) signed during his early months in office have a direct impact on the U.S. Food and Drug Administration (FDA), and by extension the life sciences industry.
These include specific EOs designed to lower drug prices by accelerating the approval of “generics, biosimilars, combination products and second-in-class brand name medications”, and to reshore domestic pharmaceutical manufacturing (including of active ingredients) by streamlining reviews of domestic products while increasing costs and reporting requirements for foreign drug-makers. The FDA is also under pressure from further executive orders designed to facilitate the Trump administration’s deregulatory agenda.
At the same time, Secretary Kennedy is spearheading the development of a new public health strategy which aims to tackle the prevalence of cancer, autism spectrum disorders, autoimmune disease, allergies and asthma—particularly among children.
“Americans of all ages are becoming sicker, beset by illnesses that our medical system is not addressing effectively”, says the EO establishing the Trump administration’s Make America Healthy Again Commission. “These trends harm us, our economy, and our security”.
For supporters, these moves represent a long-overdue disruption of the status quo. But within the life sciences sector there has also been disquiet at the speed at which health policy is changing—and fears that the scientific rigor of the U.S. regulatory process is being diluted by the administration’s measures and approach.
The FDA has lost a number of career scientists from senior positions since the Trump administration took office, with Secretary Kennedy reportedly planning substantial reductions to the number of FDA staff. Major cuts are also planned to federal funding for scientific research, while the impact of the EO entitled “Unleashing prosperity through deregulation”—which aims to reduce the volume of regulation by requiring new measures to be accompanied by the removal of 10 existing rules—has caused concern within the industry.
Meanwhile, the withdrawal of the U.S. from the World Health Organization has raised questions over U.S. participation in, and alignment with, global regulatory standards.
This, coupled with the threat of increased tariffs on pharmaceutical imports, has created uncertainty for U.S. life sciences companies that sell their products globally and that have complex cross-border supply chains.
New leadership at the Department of Health and Human Services and the FDA
Robert F. Kennedy Jr. was sworn in as health and human services (HHS) secretary in February. Secretary Kennedy initially ran for the Democratic presidential nomination before standing as an independent and eventually supporting the candidacy of President Trump.
Secretary Kennedy’s Make America Healthy Again campaign (MAHA) championed “health freedom” and promised to prioritize “liberty and environmental integrity as cornerstones of a thriving nation”.
In September, the MAHA Commission launched a 128-initiative strategy that includes policy recommendations aimed at examining and addressing the root causes of childhood chronic disease. These include developing a new vaccine framework and addressing vaccine injuries, limiting food dyes, enacting stricter rules on pharmaceutical advertising, defining ultra-processed foods, and closing generally recognized as safe (GRAS) food ingredient loopholes.
Secretary Kennedy was a controversial choice for the role of America’s top health official given his repeated unsubstantiated claims about corruption within the FDA and the broader pharmaceutical industry and his views on vaccine efficacy and water fluoridation, among other things.
While MAHA supporters have welcomed his focus on exercise, natural foods and supplements over prescription drugs, Secretary Kennedy has been accused by his critics of cherry-picking study findings and promoting therapies that are not supported by scientific research. His comments that parents of newborns should “do their own research” before vaccinating their children have been criticized for going against decades of public health advice.
On June 9, Jim O’Neill was sworn in as deputy health secretary. Having previously held senior roles at HHS between 2002 and 2008, he has since then worked at an investment fund, the Thiel Foundation, and a health research group seeking regenerative medical solutions for age-related diseases.
Welcoming Mr O’Neill, Secretary Kennedy said he would “help us harness cutting-edge AI, telemedicine, and other breakthrough technologies” and “promote outcome-centric medical care, champion radical transparency, uphold gold-standard science, and empower Americans to take charge of their own health”.
New administration prompts leadership and staff changes
In March, a bipartisan vote in the Senate confirmed Marty Makary, a British-American surgeon, as the new head of the FDA. Welcoming the appointment, Secretary Kennedy praised Dr. Makary’s “extensive research, clinical experience, and national leadership”.
While Dr. Makary has promised to “ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense”, since the Trump administration took office, the agency has lost a number of long-serving senior doctors, scientists and policymakers across multiple divisions.
Among those to resign their posts have been Dr. Peter Marks, who had been head of the Center for Biologics Evaluation and Research (CBER) since 2016; Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER) since 2021; and Jim Jones, head of Human Foods since 2023.
The Center for Devices and Radiological Health (CDHR), meanwhile, has lost its Digital Health Center of Excellence director and deputy science director.
Senior officials put on administrative leave include Julie Tierney, acting director; Dr. Peter Stein, director of the Office of New Drugs; and Dr. Hilary Marston, chief medical officer.
“These deep cuts and the loss of experienced leadership at virtually all the major centers that regulate the safety of food, drugs, devices is quite high risk”, said Dr. Jesse Goodman, former chief scientist at the FDA and director of Georgetown University’s Center on Medical Product Access, Safety and Stewardship.
Following the exit of Dr. Marks, who oversaw the government’s vaccine program, John Crowley, president and CEO of biotech industry association BIO, voiced his concern that the loss of experienced leadership at the FDA would “erode scientific standards and broadly [affect] the development of new, transformative therapies”.
Dr. Vinay Prasad, a critic of U.S. government Covid policies on school closures, mask mandates and booster shots, took over the CBER in May. One of his first moves was to end Covid boosters for healthy people under the age of 65 unless manufacturers can demonstrate efficacy for that group using randomized, controlled trial data to evaluate clinical outcomes. (The latter point is in line with FDA Commissioner Makary’s views on the benefits of such trials, outlined in his recent book, Blind Spots).
Dr. Prasad stepped down from the agency in July, following a conservative backlash against his decision to pause the use of a drug linked to two patient deaths. However, he was reinstated a few weeks later.
Meanwhile, Kyle Diamantas, a corporate lawyer and policymaker who is reportedly close to the Trump family, has been appointed as deputy commissioner for human foods, where he oversees the agency’s activities relating to nutrition and food safety.
The changes in leadership come against a backdrop of significant reductions in FDA staff. In early April around 3,500 jobs were cut, although some scientists and inspection staff were subsequently reinstated after the layoffs interrupted the agency’s oversight of drug and food safety.
Overall, the FDA will reportedly lose close to a quarter of its staff through a combination of layoffs, early retirements and voluntary redundancies through President Trump’s second term.
Fast-tracking and deregulation: benefit or risk for consumers?
On May 16, Grace Graham, the FDA’s deputy commissioner for policy, legislation and international affairs, gave a speech outlining the FDA’s strategy under Secretary Kennedy’s leadership. Appointed to her role in March, she has held policymaking positions under Democrat and Republican presidencies.
Deputy commissioner Graham stated the agency’s objective to reduce the time it takes to develop new medicines, especially those targeting rare diseases. She also highlighted plans to use technology to streamline drug development, phase out animal testing, and accelerate development of generics and biosimilars (complex medicines made from living organisms such as cells, bacteria, or yeast). These moves, she said, would cut drug costs and increase accessibility.
Her speech confirmed that the FDA would follow the administration’s ten-for-1 rule, which requires federal agencies to cut ten pieces of regulation or guidance for every additional piece introduced. While Ms. Graham said the policy would not “hamstring us from issuing the necessary regulatory documents” to ensure safe, effective access to high-quality drugs, others have expressed doubts over applying the ten-for-1 rule to the work of the FDA.
According to analysis from Politico, there are more than 170 life sciences-related guidance documents under development or in the pipeline at the agency. If the EO were followed to the letter, to publish them all, the FDA would need to remove more than half of the guidance documents currently in circulation.
Secretary Kennedy and President Trump have both expressed their support for eliminating the FDA’s user fee programs, seeing such payments from industry participants as a threat to the regulator’s independence. Such a move, which would have to be approved with a congressional act, would leave taxpayers to cover the funding gap. Ms. Graham suggested in her speech that these fees could be “restructured and simplified” at their next reauthorization in 2027.
There are concerns over the administration’s deregulatory agenda, which has targeted pre-market approval requirements for medical products, labeling and advertising disclosures for dietary supplements and processed foods, and limits the FDA’s post-market surveillance and recall authority. Critics argue that this scaling back benefits industry players at the expense of safety.
Speaking on a podcast in June, Secretary Kennedy stated that alternative treatments such as stem cells, vitamins, peptides, and chelation therapy should be less regulated.
He acknowledged however that “of course you’re going to get a lot of charlatans, and you’re going to get people who have bad results. Ultimately, you can’t prevent that either way. Leaving the whole thing in the hands of pharma is not working for us”.
Industry sources say the administration has either proposed or implemented significant cuts to the FDA and United States Department of Agriculture (USDA)’s operating budgets including via job cuts among inspectors, lab technicians, and scientific reviewers; reductions in the infrastructure supporting foodborne illness surveillance, drug shortage tracking and enforcement databases; and delayed modernization of regulatory systems (e.g., for electronic submissions, data transparency, and AI-driven oversight tools).
Drug development, approvals and pricing
Job cuts at the FDA are reportedly already slowing the drug approval process and causing the agency to miss deadlines. There are fears that staff reductions could result in less engagement between drug developers and the FDA.
While big pharma companies have large scientific and legal teams and are well-versed with the FDA process, this dynamic could disproportionately impact smaller innovators, which typically engage intensively with the agency through the development cycle.
Secretary Kennedy has been vocal about his concerns regarding the FDA’s use of emergency use authorizations (EUAs) and accelerated approval pathways, particularly in the context of vaccine development. He has expressed a preference for more rigorous testing, including potentially requiring new vaccines to be tested against placebos, which is a controversial stance among public health experts.
There are concerns that any deprioritizing of post-market safety systems could lead to delays or underreporting of adverse event data; inadequate tracking of drug interactions and long-term outcomes; and increased public health risks from recalls of compounded drugs, biologics, or combination products accelerated for approval as part of the administration’s plan to lower drug prices. (We explore some of the antitrust implications of these moves here)
At the same time, the U.S. Department of Commerce has initiated a Section 232 national security investigation into imports of pharmaceuticals and pharmaceutical ingredients. The probe—which will conclude at the end of this year—will cover finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients (APIs), key starting materials, and derivative products.
Similar investigations into aluminum, steel, cars, and car parts have resulted in significant tariff increases.
Stance on vaccines prompts continued controversy
On June 9, Secretary Kennedy wrote an opinion piece in the Wall Street Journal explaining his decision to remove all 19 members of the Advisory Committee for Immunization Practices (ACIP), eight of whom had been appointed during the final weeks of the previous administration. He said the move would put “the restoration of public trust above any pro- or antivaccine agenda” and “ensure the American people receive the safest vaccines possible”.
The ACIP evaluates the safety, efficacy and clinical need for vaccines and passes its findings on to the Centers for Disease Control and Prevention (CDC). Secretary Kennedy said the committee was “plagued with persistent conflicts of interest and has become little more than a rubber stamp for any vaccine”.
At the time, public health experts and former officials voiced concerns that the action would “exacerbate mistrust in vaccines”, and cause challenges for doctors, nurses and pharmacists.
However, Secretary Kennedy swiftly appointed eight new members to the committee, describing them as “highly credentialed scientists, leading public-health experts, and some of America’s most accomplished physicians”.
Groups such as the American College of Physicians said the new members had been selected too quickly and without transparency, causing “confusion and uncertainty”.
In May, Secretary Kennedy and Commissioner Makary announced that the CDC would remove Covid-19 booster shots from its recommended immunization schedule for healthy children and pregnant women.
The CDC, however, said it would retain Covid vaccines for healthy children age six months to 17 years old, as long as there is “shared decision-making” between families and their doctors.
This followed a new requirement by the FDA that drug manufacturers conduct more studies as a condition for approving updated Covid vaccines for healthy adults under age 65. It will likely still be possible for doctors and pharmacies to recommend and administer the vaccine off-label, but insurance may stop covering the cost for that demographic.
In August, the administration fired CDC director Susan Monarez after just a month, saying she was “not aligned with the president’s agenda”, replacing her with deputy health secretary Jim O’Neill. Chief medical officer Debra Houry is among senior officials to have resigned in recent months, warning of a “rise of misinformation” about vaccines.
Medical devices benefit from innovation, but require more surveillance
Under Secretary Kennedy, the FDA would like to see more citizens take responsibility for their own health. As deputy commissioner Graham said in her recent speech: “Medical devices can help Americans better track their own health needs before they get sick and creating conditions for more of these products and information to be available without a prescription can maybe help some avoid more severe disease”.
At the same time, the administration is also pursuing an aggressive deregulatory agenda designed to prioritize speed to market.
To accelerate access to novel medical devices, the government could expand the 510(k) pathway under which companies make a pre-market submission to the FDA to demonstrate that their product is as safe and effective as another device that is already on the market.
It is also thought to be under pressure to accept real-world evidence and to go further with the “least burdensome” approach introduced in 2019. Industry sources are concerned that such a move could reduce oversight and clinical evidence requirements for many devices.
Another risk is that staffing cuts at the FDA’s Center for Devices and Radiological Health (CDRH) could delay public notices related to medical device recalls and safety alerts, slow device reviews and curtail post-market reviews.
Resource constraints are also creating bottlenecks for complex applications and weakening FDA enforcement capacity. Key programs like inspections, compliance follow-ups, and data modernization programs are similarly being delayed.
Cuts are likely to exacerbate existing flaws in the system, including in relation to the FDA’s surveillance infrastructure. Here, manufacturers do not consistently inform the agency about adverse events involving medical devices using MAUDE, a searchable database of medical device reports (MDRs). A study in the British Medical Journal (BMJ) found that nearly a third (over 1.2 million) of initial manufacturer reports were not submitted on time between September 2019 and December 2022.
Withholding safety information may “cause avoidable patient harm”, which could be prevented if the FDA “systematically and prospectively collected” post-market monitoring data rather than relying on self-reporting, said report author Alexander Everhart.
Efforts by the FDA to increase active surveillance using electronic medical records and insurance claims have been hampered by devices frequently lacking unique device identifiers (UDIs), despite bipartisan calls to make them mandatory.
Late death reports in particular were disproportionately more common if they were associated with breakthrough devices, which benefit from speedier development, assessment, and review for premarket approval. The fact that the agency has scaled back its active post-market monitoring work raises the risk that dangerous or defective devices remain in circulation.
In July 2024, the Government Accountability Office (GAO) said that more than 1.7 million injuries and 83,000 deaths had been potentially linked to faulty medical devices over a ten-year period. The FDA, it continued, had begun building a surveillance system to look for potential safety issues in devices from surgical masks to implantable pacemakers. Obstacles to setting up the system—identified as a priority since 2009—included funding and identifying the patients using the devices.
Another area where the FDA (and other agencies) is playing catch-up is in response to the rapid proliferation of AI in medical devices. It has proposed draft guidance for adaptive algorithms, and will require funding, political backing, and internal consensus to finalize and enforce robust rules. CDHR has furthermore been subject to layoffs of recently hired specialists in artificial intelligence and machine learning.
Technology-enabled products such as digital therapeutics, and software-based tools often fall between regulatory jurisdictions, creating ambiguity in classification, review, and enforcement. A digital device for example, might be regulated by the Federal Communications Commission (FCC) and FDA, with additional oversight from the Consumer Product Safety Commission (CPSC) and Federal Trade Commission (FTC)—while being subject to certain privacy and security laws.
Overcoming this—while enabling innovation in a way that is safe for patients—will require more coordination among FDA units, as well as inter-agency harmonization.
In her May 16 speech, Grace Graham said the FDA was concerned about the number (and standard) of clinical trials taking place abroad. She added that addressing this would require new infrastructure in the U.S., and the “streamlining and modernizing” of regulations such as Good Laboratory Practices, which was last adapted in the 1970s.
However exactly what this process would entail remains to be seen.
Legal challenges to the FDA’s authority
In the meantime, legal and judicial challenges are increasingly aimed at constraining the FDA’s rulemaking and enforcement powers.
Courts are also leveraging nondelegation arguments that challenge the constitutionality of federal agency discretion. These efforts are supported by the Supreme Court’s decision to end the “Chevron deference” (which gave federal agencies broad powers to interpret ambiguous laws and statutes). They may also curtail the FDA’s ability to regulate emerging technologies or impose new obligations on innovators. Industry-aligned litigants are also challenging new FDA guidance as improper rulemaking, seeking to weaken the agency’s ability to adapt without new legislation.
Looking ahead, it’s possible that these shifts could increase the risk of judicially imposed paralysis in emerging areas of regulation, such as AI-driven diagnostics or genetically modified organisms.
Isolation, immigration and trade
A rejection of multilateralism reduces U.S. influence in shaping global norms and could ultimately lead to U.S. products being isolated from international markets if they don’t maintain compliance with stricter regulatory standards overseas.
The Trump administration has ordered an immediate halt to engagement of all kinds with the WHO (although the U.S. cannot officially leave until 2026), and the FDA is likely to diverge from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards by replacing or reducing in vivo toxicology testing for certain drugs.
The U.S. withdrawal from the WHO has locked it out of the Codex Alimentarius (food standards) body. Meanwhile the Trump administration has also paused further funding for the World Trade Organization (WTO), threatening its influence over WTO trade and safety standards discussions.
This, plus the fact that the FDA is now less active in global bodies such as the International Medical Device Regulators Forum (IMDRF), will likely weaken U.S. influence over the development of new regulatory frameworks. At the same time, escalating trade tensions could lead to further misalignment with foreign regulatory systems, creating uncertainty for U.S. exporters and importers.
We are already starting to see major U.S. pharma companies seeking initial regulatory approvals in Europe rather than at home in order to preserve their ability to sell their products globally. They may also consider expanding their R&D, testing and production capabilities outside the U.S. in jurisdictions with access to skilled talent.
At home, the administration has launched measures to tackle illegal immigration, which is set to significantly reduce the labor force in agriculture and meatpacking. Trade disputes meanwhile will likely slow inspections at ports of entry due to resource strain in the FDA, and at U.S. Customs and Border Protection.
Dwindling domestic production of ingredients for drugs could increase reliance on imports from countries with weaker regulatory regimes, without proportional inspection capacity. Likewise, bottlenecks in the global pharmaceutical supply chain could cause shortages of active pharmaceutical ingredients (APIs), among other challenges.
When highlighting the administration’s desire to reshore pharmaceutical manufacturing, FDA deputy commissioner Grace Graham noted that 73% of all FDA-registered manufacturing facilities of active pharmaceutical ingredients and 52% of all FDA-registered finished drug manufacturing facilities are currently located outside the U.S., with China as a leading global supplier. The Trump administration is bidding to reduce the current five to ten years it takes to build the relevant domestic facilities.
At the same time, the FDA would like to “reverse the trend” of innovative drugs being first developed overseas. Deputy commissioner Graham noted that some global studies “may not be representative of the U.S. population”. FDA regulations require that, to use foreign data as the sole basis for marketing approval, it must be “appliable to the U.S. population”, so it is possible that Graham was implying such considerations could be leveraged in future to limit imports of certain products.
Tariffs could push overseas production to the U.S.
In early August, President Trump announced plans to place an initial “small tariff” on pharmaceutical imports into the U.S.
“In one year, one and a half years maximum, it’s going to go to 150% and then it’s going to go to 250% because we want pharmaceuticals made in our country,” he said in an interview.
