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# FDA Obstacles Lead to Overseas Trials: Survey
- URL: https://www.fdaweb.com/fda-obstacles-lead-to-overseas-trials-survey/
- Published: 2026-08-12T12:00:00.000Z
- Updated: 2026-09-14T13:44:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161615

While U.S. biotech companies focused on treating rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the U.S., historical obstacles posed by FDA are prompting the companies to seek development overseas. That’s a key finding from a survey of 37 U.S. biotechnology executives conducted by the Biotech Consortium to Accelerate Innovation. A survey [report](https://www.businesswire.com/news/home/20260812482557/en/New-Survey-Finds-U.S.-Biotechs-Advancing-Treatments-for-Rare-and-Serious-Diseases-Want-to-Run-Clinical-Trials-in-U.S.-but-Regulatory-Hurdles-are-Sending-Them-Abroad?ref=fdaweb.com) says:

- 76% of interviewees pick the U.S. for FIH trials when review is predictable;
- 72% are hesitant to run FIH trials in the U.S. under FDA’s historical framework;
- 73% say the top reason why sponsors are leaving the U.S. is delay and financial cost tied to FDA clinical holds and rework;
- surveyed executives cite “current turmoil at FDA with high turnover” and warn the U.S. is “offshoring our industry faster than we can catch up”;
- 54% of the executives say they are less likely to test new drugs in the U.S.; and
- 85% support fixing FDA’s “1/10 rule” so it sets a safe starting dose and not a treatment ceiling.

Proposed solutions identified in the survey are:

- clarify that the 10x safety margin sets a starting dose and not a treatment ceiling as outlined in a 2005 FDA guidance;
- restore predictable review timelines that reduce costly holds and rework;
- strengthen sponsor-reviewer communication so trial design is driven by science, not procedural ambiguity;
- ensure better alignment of review criteria with disease severity and life expectancy;
- improve benefit/risk framework that considers the patient’s voice; and
- use a central institutional review board for first-in-patient studies.