The recent political developments in the United States, marked by Donald Trump’s return and his administration’s intention to drastically alter healthcare regulations, have brought to the forefront the critical issue of safeguarding independent, evidence-based research. Particularly concerning are statements indicating a potential downsizing of the Food and Drug Administration (FDA), an entity previously subjected to reform proposals and now facing the risk of deregulation that could undermine the scientific integrity of the approval system.
A recent editorial in The Lancet has highlighted this issue, urging Europe to decisively reaffirm its leadership in promoting equitable, inclusive, and evidence-based medical science. The article warns of the dangers inherent in a model that prioritizes process acceleration at the expense of methodological robustness, potentially causing global distortions. The most tangible risk is the increasing exclusion of vulnerable groups—such as children, the elderly, and women—from clinical studies, violating principles of representativeness and distributive justice that modern medicine can no longer afford to overlook.
Deregulation and selective science: a dangerous combination
The debate over FDA deregulation is not new but gains new dimensions in light of Trump’s rhetoric opposing “economic freedom” to “federal bureaucracy.” This narrative ignores the importance of evidence quality and the necessary balance between rapid access and rigorous evaluation. As noted in a recent contribution to Health Affairs, the growing pressure to approve new drugs based on preliminary phase I or II studies, often lacking robust comparative efficacy data, risks creating false expectations and compromising patient safety.
The tendency to view data as “strategic assets” and to bend scientific metrics to political or commercial interests occurs in a context already marked by complex challenges: from the shortage of expert reviewers to the growing pressure from the biotech industry, from the fragility of the peer-review system to the increasing opacity of data in registration trials.
Italy’s Role in the European Context
In this scenario, Italy is also called upon to strengthen its contribution to the European regulatory system. In recent years, the Italian Medicines Agency (AIFA) has taken significant steps toward greater transparency in decision-making processes, as evidenced by the opening of Health Technology Assessment (HTA) reports and the publication of data related to drug reimbursement. However, critical issues remain, starting with the average duration of access times to new drugs compared to the EU average, and the need to strengthen Italian participation in European task forces for post-HMA/EMA rule harmonization.
At the academic level, projects like the Alliance for Biomedical Research in Italy (ARBI) and Convergenza have sought to foster dialogue between public research, industry, and institutions, promoting an integrated approach to clinical data evaluation. Furthermore, journals such as Recenti Progressi in Medicina and Giornale Italiano di Farmacoeconomia have repeatedly highlighted the need to invest in a culture of evidence-based policymaking, to counteract localistic tendencies or heterogeneous approaches that risk undermining trust in the system.
It is also important to consider the impact these global dynamics can have on training processes: specialization schools, doctoral programs, and Italian IRCCS (Scientific Institutes for Research, Hospitalization, and Healthcare) are tasked, now more than ever, with training professionals capable of critically reading literature, understanding study limitations, and contributing to the construction of solid, ethically robust, and scientifically verifiable protocols
An opportunity for Europe: leading science with rigor and inclusivity
In the current context, Europe has not only the opportunity but the responsibility to offer a credible alternative—a regulatory model that does not succumb to the temptation of shortcuts but strengthens scientific and ethical safeguards to protect public health. This is a crucial aspect of the credibility of European institutions: promoting representative multicenter studies, harmonizing evaluation criteria between the EMA and national authorities, enhancing data transparency, and ensuring decision-making processes independent of political or economic influences.
The European Commission, through programs like Horizon Europe and the emerging European Health Data Space, has shown encouraging signs in this direction. But a stronger, more cohesive leadership is needed. Italy can play a central role, leveraging its scientific network, the strength of its medical schools, and the innovative drive of startups and SMEs in the biotech and life sciences sectors.
Rigore, evidenza, rappresentatività
The challenge today is not only technical or regulatory but profoundly cultural. It is about choosing between science guided by transparency, continuous verification, and data representativeness—or selective science, driven by contingent interests. Europe can—and must—make a difference, reviving a vision of research as a common good, the foundation of progress, and an instrument of equity.
In the global comparison with more permissive models or “regulatory shortcuts,” Europe’s—and Italy’s—strength will not only lie in the quality of its data but in the quality of its choices. Because well-conducted science does not need to rush; it needs to endure.