In the Press
January 10, 2023

FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs (The Wall Street Journal)


The Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies, according to The Wall Street Journal. The agency, which must sign off before companies can begin testing an experimental drug in people, has long used its authority to place holds on studies due to safety concerns. As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a Wall Street Journal review of FDA data on clinical holds, some of which was obtained through a Freedom of Information Act request. A clinical hold “can be very damaging to not only what the medical community might think of the program, but also what investors might think of the company’s approach,” said Julie Tibbets, chair of the FDA practice who advises companies facing clinical holds. “It casts a bit of a dark cloud that then the company has to find its way out from.”