In recent weeks, biotech companies have faced setbacks in moving forward with clinical trials due to operational delays at the FDA, according to an exclusive report from The Wall Street Journal published April 17.
Five things to know:
- Biopharmaceutical firms developing treatments for hard-to-treat conditions say they are facing delays in routine FDA processes, including clinical trial guidance and regulatory feedback. In some cases, the agency is missing standard timelines for communicating next steps, leading to trial postponements and shifts in global development strategies. Industry officials told WSJ the disruptions are leading to longer drug development timelines and increased uncertainty for both companies and investors.
- One biotech company developing a treatment for a life-threatening genetic respiratory disease said it has not heard back from the FDA regarding an amendment to a clinical trial it had planned to start later this year. The amendment, submitted in March, would allow patients to take steroids to manage side effects.
Drugmakers typically expect such requests to be reviewed within several days. With no response as of mid-April, the company plans to shift its focus on trial activity in Europe, an official with the company told WSJ.
- The regulatory delays come after 3,500 FDA employees were laid off in early April as part of HHS Secretary Robert F. Kennedy Jr.’s broader department restructuring efforts. Several senior officials at the agency — including Hilary Marston, MD, chief medical officer, and Peter Stein, MD, who oversaw the approval of new drugs — were affected by the layoffs.
- “FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ensuring critical programs and testing continue,” a spokesperson for the FDA told WSJ.
- Trial delays can lead to mounting costs for drugmakers, particularly smaller biotechs that rely on timely FDA decisions to maintain funding and hit development goals. Regulatory setbacks can derail planned timelines, increase overhead and jeopardize potential product launches — issues that are especially risky in a challenging market where many companies are already struggling to raise capital, executives told WSJ.
