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Public Citizen Health Research Group v. FDA (NDA reviews)

As part of the Food and Drug Administration’s consideration of new drug applications, the FDA conducts scientific reviews within different disciplines (for example, pharmacology, medicine, and statistics). When, following the completion of this review process, the FDA approves a new drug application, it publicly posts online an “action package.” The action package includes review documents prepared by reviewers in each discipline and various other documents generated during the review of the application. Historically, each discipline provided a separate written review, which the FDA included in the action package posted online.

In June 2019, the FDA announced that it had begun to utilize a new integrated review process and documentation template, whereby reviewers would create one collaborative document, rather than preparing independent reviews. Following this change, the FDA’s action package for the prescription drug Balversa contains a multidiscipline review, not separate reviews from the reviewers in the different disciplines.

In October 2019, Public Citizen submitted a FOIA request to the FDA for any documents written by the individual reviewers listed in the Balversa multidiscipline review from which analyses, recommendations, or any other information was extracted, excerpted, and/or summarized for inclusion in the multidiscipline review for Balversa. The FDA failed to respond to the FOIA request, and Public Citizen filed a lawsuit seeking disclosure of the requested records. After we filed suit, FDA told us it had no responsive records, and we dismissed the case.