The U.S. Food and Drug Administration (FDA) recently proposed a rule on Reporting Information Regarding Falsification of Data (to be codified at 21 C.F.R. pts. 16, 58, 71, 101, 170, 171, 190, 312, 511, 571 and 812) that would require companies, including drug and device manufacturers, to report confirmed or suspected falsification of study data. The purpose of the proposed rule is to "ensure the integrity of data submitted to FDA because reliance on falsified data could lead to clinical testing of unsafe products, approval of ineffective or unsafe products, or marketing of products with false or misleading claims." The proposed rule puts the onus on study sponsors to report falsifications because FDA believes that study sponsors are "in a better position [than FDA] to discover possible falsification of data through their monitoring, auditing, and reviewing of data." FDA urges that the proposed rule "would allow the agency to more rapidly identify persons who have falsified data and more effectively address problems."
Under the rule, FDA would require a sponsor to notify the agency within 45 days of learning of a falsification or a suspected falsification in studies involving human or animal subjects. The rule would apply to data falsification "in the course of reporting study results, or in the course or proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects (e.g., clinical investigations) or animal subjects (e.g., nonclinical laboratory studies and clinical studies in animals) conducted by or on behalf of a sponsor or relied on by a sponsor." For example, the rule would cover data falsification, forged informed consent forms, modifying laboratory measurements and values, and omitting exclusionary medical history, but would not cover unintentional errors, such as typographical errors or plagiarism.
Reports submitted under the rule could result in administrative or enforcement actions such as "excluding clinical trials from consideration by FDA, placing a clinical trial on hold, or initiating disqualification of investigators or criminal proceedings." Parties seeking to comment on the proposed rule must submit comments by May 20, 2010.