The sweeping changes seen since January 2025 represent tectonic shifts in the foundations of healthcare in the U.S.–transformations that are likely to have targeted impacts on how new medicines are discovered, regulated and potentially even promoted. Furthermore, as the Food and Drug Administration (FDA) sets global standards in many ways, any disruptions or shifts in its operations could create a ripple effect in other regulatory agencies around the world, including the European Medicines Agency (EMA).  

Some of these impacts will be felt long-term, and others may become apparent much sooner. Recent media stories have spotlighted staffing shortages as a cause for potential delays in medicine approvals, but the implications may run deeper. Beyond timing, we could see fundamental shifts in how drugs are evaluated and approved, as evolving administrative priorities reshape the regulatory pathway itself.

The Reduction in Workforce as a Factor in Potential Delay

The reduction in federal workforce policies are far reaching. With respect to FDA, the impact is complex and needs to be viewed from multiple perspectives to assess the potential full implications on the approval process for medicines.

While mid-February saw an initial wave of terminations across the entire agency, it was followed by a broader reduction of 10,000 staffers across the Department of Health and Human Services (HHS). And in the wake of each, there were subsequent modifications to the actions taken. For example, medical device and drug reviewers were deemed exempt from the terminations. Following the April layoffs, media outlets reported that HHS Secretary Robert F. Kennedy, Jr. stated that approximately 20% of the staffers who were discharged in the latest round may be erroneous and could be reinstated. However, no plan has yet been announced for effecting that correction.  

The attrition of staff through layoffs is further compounded by those leaving the agency for other reasons. In January, the federal government offered employees an option to resign by February 6, 2025, and retain salary and benefits through September 2025. In March, HHS extended another offer to buy out employees. While it has been estimated that tens of thousands of employees accepted, the specific number of FDA employees who have left is not currently publicly available.

What is known is that many key personnel who would be involved in new medicine approvals have also voluntarily left the agency, including the Director of the Office of New Drugs within the Center for Drug Evaluation and Research (CDER), the Director of the Center for Biologics Evaluation and Research (CBER) and the Deputy Director of CBER. In addition, prior to the start of the new administration, the head of CDER also resigned.

Some of the vacated positions have been replaced from within. However, due to the hiring freeze that was put into effect by executive order on January 20, 2025, the agency is losing key staff without an ability to recruit and replace them. Clouding the situation further, the HHS reductions in personnel may face legal challenges.

Finally, the drug approval process is long and complex and not solely left to the reviewers whose jobs have been exempted from the workforce reduction. Reductions in communications and legal staff may also disrupt key processes, while cuts to FDA inspection personnel, particularly those responsible for overseeing foreign manufacturing facilities, could delay new approvals if inspection capacity is diminished.

Has all this disruption negatively impacted the new approval of drugs?

At this stage, the answer is not clear. One way to assess it is by examining the timeliness of the agency in meeting its approval commitments. Under the Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and periodically reauthorized by Congress, FDA accepts user fees from pharmaceutical companies allowing expansion of resources to review new medicines, and in return, agrees to review a new drug application in a set time frame. These are referred to as “action dates” or “PDUFA dates.”  While these dates are proprietary information, companies do often reveal the timing of when a decision is expected by FDA.

In reviewing publicly known action dates for 2025, while some have been altered or missed, there does not seem to be a pattern to indicate that FDA is proceeding at any interrupted pace.

Another resource to consider is the approval of novel drug applications, also known as new molecular entities (NMEs), which are reported by FDA on its website. The number of NMEs approved for 2025 is lower than in any year since 2021, but this dip could stem from a range of factors. Only over time will it become clear whether this reflects a true slowdown or normal variation.

The Potential for Change in the Process for Approving Drugs

When a new application is submitted to FDA, it is likely there has been consultation with the agency prior to submission. The depth and scope of exchanges between agency and sponsor will vary depending on the drug, the treatment area and the status that is accorded the application.

Once submitted, FDA decisions regarding that new application have traditionally happened in one of two ways. The most common involves an in-depth analysis of every aspect of the application and assessment by qualified review staff at FDA. Once review staff have completed that task, barring any outstanding questions regarding clinical studies showing efficacy and safety, and following inspection of manufacturing facilities, the agency will issue a decision. This comes in the form of an approval or a Complete Response Letter (CRL) outlining what the agency would like to see to approve the application. This decision usually arrives on or before the PDUFA date.

An alternative path for a new drug application arises when the FDA has unresolved questions and seeks input from both external experts and the public. In that case, FDA calls an advisory committee meeting and embarks on a more transparent process. There are 17 different panels of advisors across various therapeutic categories, each one staffed by an FDA employee.

If an advisory committee is called, historically a public meeting is announced in the Federal Register and a public docket is opened for written input from the public, which is then distributed to the panel of advisory experts. Prior to the meeting date, the FDA publishes on its website all relevant aspects of the drug application, enunciates questions for discussion and proposes a vote on one or more of them, usually ultimately voting to recommend or not the approval of the application – advice that FDA may or may not follow. The meeting is held to discuss the application, and the public – often involving clinical investigators and patients – is invited to give in-person comments during a portion of the meeting.

The reductions in workforce affect both of these approval pathways. In addition to FDA review staff, legal and communications support – both impacted by staffing cuts – help facilitate the application assessment process.

Additional Factors Adding to Approval Process Uncertainty

An early action by the administration was to put into place a communications freeze for federal agencies. The impact on FDA has been notable, with few press releases issued since the beginning of the new administration. The FDA Roundup, typically containing multiple news items published several times a week is now at a near standstill. There have been scant notices about agency activities published in the Federal Register, none of which have been for the purpose of announcing a meeting. FDA Advisory Committee meetings that had been scheduled were postponed. In short, the process for Advisory Committee meetings described above is in limbo. It is not clear whether FDA has the staff that would be necessary to conduct such a meeting and, if so, how key stakeholder perspectives, like those of patients, would have the ability to contribute.

Other factors also raise concerns about the current process.

HHS Secretary Robert F. Kennedy, Jr. has expressed discomfort with the relationship between FDA and industry. One area of concern is the existence of potential conflicts of interest of members of committees advising NIH and specifically CDC and FDA committees related to vaccines. It is not clear if that view encompasses all advisory committees.  

As a part of that concern, the Secretary has also expressed criticism of the Prescription Drug User Fee Act, which supplies a substantial portion of the FDA budget to shorten the review times of applications. While negotiations for the next round of PDUFA reauthorization are not scheduled until 2027, media reports that existing staff who facilitate activities in support of the PDUFA fee structure have been largely eliminated, calling into question the more immediate impact on the PDUFA system.

Secretary Kennedy has also expressed reservation about the need for public input into HHS decisions. It is unclear at this time if this will extend to the role of public comment in the FDA review process.

In short, the existing process for the review of drugs appears to be in stasis, with many aspects potentially coming under scrutiny and facing the possibility of change or elimination. Currently, there are many compounds in the pipeline awaiting FDA process for decision-making. Between the staff changes and the potential for new policy developments in relation to the process, delay is a distinct possibility.

Worldwide implications?

It would be remiss to not also recognize the far-reaching impact that changes at the FDA may have on regulatory bodies worldwide. These changes are likely to have significant global implications, particularly for the EMA, which often relies on FDA data and early approvals to expedite its own drug review processes. Disruptions at FDA, whether due to staffing reductions or policy shifts, could lead to delays not only in the U.S. approval process but also in other key global markets.

The EMA, which frequently aligns its review processes with the FDA’s, could face challenges in synchronizing approval timelines, potentially slowing access to critical medicines in Europe. Similarly, regulatory bodies in other regions – such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Health Canada – may also be affected. These agencies often monitor and adapt to FDA decisions, so delays or changes in FDA operations could trigger a cascade effect, potentially slowing the global approval process for new therapies.

Implications for Communications

For communicators supporting this process, either from inside the pharmaceutical and biotech industries, or the agencies that support them, there are an array of implications. Policies enacted are broad, sometimes vague in scope and can be unclear in their application. Therefore, in planning around new approvals and pipeline medicines, a new level of uncertainty must be built into the equation by communications teams.

Navigating uncharted waters demands close monitoring of the evolving landscape, regular assessments of potential scenarios and an understanding of vulnerabilities to those changes. It also requires strategic planning, both operationally and communicatively, to reinforce preparedness and mitigate risks.

Communications planning must be both broad enough to reflect the landscape and specific enough to address the circumstances of a particular drug or therapeutic category. It also must encompass the ability to anticipate and respond quickly to unfolding developments. Moreover, it needs to consider scenarios that accompany not just a single delay, but multiple delays.

Ultimately, applying the traditional model of communications around approvals for the future may be a thing of the past. Communications teams will have to build a new model built around greater uncertainties in the process moving forward.