WASHINGTON (CN) – The Food and Drug Administration plans to amend its regulations to require sponsors of product applications for FDA approval to report any indications of the falsification of data regarding studies that involve human or animal subjects. The rule is being proposed due to apparent misunderstanding by the sponsors.
In the mid- to late-1990s “some particularly egregious cases of falsification of data by clinical investigators” occurred, including a case in which “an investigator falsified data that extended across studies in 91 applications submitted to FDA by 47 sponsors,” according to the proposed FDA rule. Since no one reported the falsification, the FDA’s Center for Drug Evaluation and Research performed a study and found that sponsors stated they were confused about the extent to which possible falsification of data had to be reported, the amount and type of information that sponsors must report after a study, or an investigator’s part in the study is over, when to report falsification, and whose falsification of data must be reported.
In response, the FDA plans to require that sponsors report any indication that there is or may be falsification in anything relied on by the sponsors, that has or may have occurred before, during or after a study, by anyone, within 45 days of becoming aware of the information.
The proposed rule would apply to all sponsors, petitioners, manufacturers and suppliers that submit requests for product approvals, new dietary ingredient notifications, or authorization of labeling claims, including nutrient content claims and health claims.