Bloomberg Law
Oct. 23, 2018, 8:03 PM

FDA Dodges Death-Inspired Suit Over Study Volunteer Consent

Dana A. Elfin
Dana A. Elfin

Two strikes, you’re out. A court rebuffed for the second time a public interest group’s suit seeking to force the Food and Drug Administration to amend its informed consent regulations to better protect clinical trial participants.

The suit was triggered by reports of at least 153 treatment-related deaths in clinical trials since 2013, including one during a cancer immunotherapy study sponsored by Juno Therapeutics Inc.

The Center for Responsible Science sued to force the FDA to add three disclosures to its informed consent regulations to give trial participants more information on the differences between animal and human testing. The group’s ...

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