Navigating the FDA disruption: 4 key actions for pharma

Significant slowdowns at the US Food and Drug Administration (FDA) following internal restructuring and layoffs pose a growing challenge for the pharmaceutical industry. As reported by The Wall Street Journal, the layoffs are part of a broader reshaping of the Department of Health and Human Services. Approximately 3,500 FDA employees — including key figures responsible for new drug approvals and biologics — were cut. According to WSJ sources, these changes have led to missed regulatory deadlines, reduced responsiveness, and a less predictable approval environment.¹

While many small biotech firms have been vocal about the near-term impact, the implications for large pharmaceutical companies are equally critical. With dozens of major clinical programs in progress and billions of dollars invested in long-term pipelines, big pharma will need an action plan in case this situation persists.

1. Double down on speed (“Control the controllables”)

Responsiveness from the FDA is out of industry’s control. If regulatory reviews are likely to take longer, the industry should accelerate its own operations to safeguard overall timelines as much as possible. This means streamlined trial designs, fewer amendments, quicker deployment of right resources and right time, and accelerated internal decision-making. Agent-based automation (AI) efforts, operating models, and decision-making processes are all in-scope.

2. Emphasize regulatory excellence ("No foot fault")

In an environment where regulatory processing is slower, industry players should avoid introducing preventable errors or incomplete filings. A single oversight in a submission — so-called “foot fault” — can trigger costly delays. Every protocol, amendment and briefing package should be buttoned up, aligned with guidance and reviewed with exceptional rigor. With the FDA's communication bandwidth stretched, companies should fill the interpretive gap. Deep institutional knowledge of regulatory precedence and enhanced internal guidance functions can allow for progress even when formal feedback is delayed or ambiguous.

3. Strengthen global regulatory diversification

Companies should accelerate parallel submissions and engagement with international regulators, such as the European Medicines Agency or Pharmaceutical and Medical Devices Agency in Japan. A diversified regulatory strategy not only spreads risk but can help maintain global timelines for launch readiness and patient access.

4. Engaging collectively to support FDA rebuilding

Industry-wide coordination through advocacy groups and trade associations can help elevate the urgency of the situation. Proactive dialogue with lawmakers and regulators can be the key to driving agency rebuilding efforts focusing on preserving the integrity and efficiency of the US drug approval system.

Though the current environment introduces uncertainty, it also presents an opportunity for leadership. With careful planning, executional discipline and collaborative engagement, large pharmaceutical companies can continue to drive innovation and patient impact — while supporting the evolution of the regulatory landscape itself.

^{1. “Drug Development Is Slowing Down After Cuts at the FDA,” The Wall Street Journal, April 17, 2025}