FDA takes wary approach on trials with cutting-edge drugs: WSJ

The FDA is increasingly hesitant on allowing drugmakers to test their cell and gene therapy candidates in human trials, The Wall Street Journal reported Jan. 10. 

Compared to 2012 through 2016, when each year saw human trial requests for experimental drugs denied 557 times on average, trials were paused 664 times each year from 2017 to 2021. From 2021 through December 2022, the FDA put 747 requests on hold, according to the Journal's investigation. 

One reason for the agency's aversion to approving human drug trials could be because of the lurking unknowns about new technologies such as cell and gene therapies, according to the Journal. Unanswered questions about the new drug developments' safety profile may be contributing to the FDA's hesitance; for example, a participant in a sickle-cell gene therapy trial developed anemia. 

Analysts also pointed out to the Journal that an overall increase in trials in recent years could be leading to more pauses.

Read the full report here

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