Discovery On Hold: How Shutdowns Stall Science And Shake Trust

By Ray Dogum, Chief Editor, Drug Discovery Online

Shutdowns do more than stall government operations. They expose vulnerabilities across the broader research ecosystem. When appropriations lapse, the ripple effects reach deep into early drug development efforts: FDA slows regulatory intake, NIH freezes grant reviews and awards, clinical trials are disrupted, and talent pipelines tighten as student and work visas remain in limbo.

These disruptions are not isolated inconveniences. They create systemic risks that compound across your drug pipeline, from early discovery to IND submission. For sponsors and CROs, the challenge is not just financially surviving the shutdown. It’s also ensuring that you can quickly adapt your project plans to the operational choke points that linger long after funding resumes.

Overall, the HHS Contingency Plan estimates 41% of HHS employees across 13 operating divisions (32,460 employees) are furloughed.

Surviving FDA Bottlenecks

According to the FDA’s Plan, the funding lapse will limit FDA’s ability to protect public health. During the shutdown, the “FDA would not be able to accept new drug applications, generic drug applications, biological product applications, biosimilar biological product applications, animal drug applications, or medical device submissions that require payment of a user fee.”

Oversight of unapproved drugs, compounded medicines, and food safety would shrink to emergency-only activities, leaving long-term initiatives paused. Inspections, regulatory science research, and policy development would be curtailed, while hiring, equipment upgrades, and innovation investments would be put on hold.

FDA operations would focus solely on imminent threats to human life, with broad impacts on health security and product availability.

NIH Significantly Scales Back Operations

With 75% of NIH employees furloughed, it’s clear that many activities that it’s normally responsible for will come to a complete halt. In fact, below is the summarized list of activities that will not continue, directly from the NIH’s Plan:

• All NIH grant peer review meetings, advisory council meetings, issuance of new awards, and program/grants management activities.
• The admission of new patients at the NIH Clinical Center (unless deemed medically necessary by the NIH Clinical Center Director).
• Initiation of new protocols at the NIH Clinical Center.
• Basic research conducted by NIH scientists.
• Translational research conducted by NIH scientists that develops clinical applications of scientific knowledge.
• Training of graduate students and postdoctoral fellows at NIH facilities.
• Scientific meetings at NIH facilities.
• Travel of NIH scientists to scientific meetings.
• Some NIH veterinary services.
• NIH scientific equipment services.
• Almost all NIH administrative functions, including the onboard of non-excepted staff.
• Most NIH mail, cafeterias, and visitor services.

It’s not difficult to imagine how stressful and challenging this can be for professionals working across the entire drug discovery pipeline. Ultimately, you need agency feedback to move your assets forward. Otherwise, you’re just burning time and money.

Academic Research on Hold

Unfortunately, early career researchers striving to complete their PhDs or Postdoc fellowships will likely become one of the most impacted groups of this political turmoil. This group depends on grant funding from the NIH to advance their research and move forward in their careers. Academic calendars don’t get put on hold during a shutdown. In many cases, there’s nothing they can do about it.

Notably, not all research labs will be directly impacted by the shutdown. On day 3 of the shutdown, I asked world-renowned engineer and MIT Institute Professor, Dr. Robert Langer, if he anticipated the shutdown would impact his tissue engineering lab or research funding. He confidently said, “I don't think our lab will be affected. I think it's very unfortunate that there's a shutdown, but I think our lab will be okay.” Dr. Langer, who has authored over 1,600 papers and has been cited over 460,000 times also shared that when he began his career, his first nine research grant applications were rejected. What if there was an active shutdown when his rejected applications were submitted? Would he have even bothered to continue submitting proposals if feedback from the NIH was delayed even further by a government shutdown? Would he have persevered through it all, or would he have found a different life path? Knowing Bob, he would have kept pushing and waited for the government to get its act together. But many early career researchers today (especially foreign nationals with J-1 and H-1B visas) wouldn’t have the opportunity to wait it out. Faced with uncertainty, they might pivot to other careers or leave science altogether.

These shutdown-related stressors add to the issues concerning the new $100,000 annual fee imposed on H-1B visa petitions. For example, current employees with H-1B visas of Penn International Scholar and Student Services received a warning in September to avoid international travel as Trump implements the annual fee.

Clinical Interruptions Lead to Broken Public Trust

Clinical trials are often the costliest stage of drug development, and unexpected disruptions can derail timelines and drive up expenses for sponsors. But it’s not just biotech companies that will be negatively impacted. As Clinical Leader reminds us, patients will feel the pain of this shutdown as well. Reopening the government won’t instantly rebuild trust in medical research. Restoring confidence among patients who were counting on potentially life-saving trials is far more complex than simply reimbursing furloughed workers.

The Silver Lining

Shutdowns are disruptive, but they also create space for reflection and recalibration. When the usual pace of filings, reviews, and site activations slows, research teams can turn downtime into strategic advantage: auditing data room quality and strengthening collaborations that often get sidelined in the rush to deliver. It is an opportunity to invest in internal training, explore alternative funding sources such as non-profits and Decentralized Science (DeSci) communities, and revisit bold ideas that rarely make the priority list.

While no one welcomes political gridlock, using this pause to plan smarter and build resilience can position organizations to move faster and more confidently when the lights come back on.

Ultimately, shutdowns are a matter of political will and complex negotiations among policymakers and partisan groups. We also know how painfully determined both sides of the aisle are during this particular shutdown. Given the fact that Trump’s last government shutdown was the longest in history at 35 days, it’s not unreasonable to expect another record-breaking shutdown this time around. Focus on what you can control and plan for the worst.