Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of falsified data that the sponsor company identifies within a proposed or current human or animal study in support of pharmaceutical, medical device, food, color additives, or dietary supplement approvals or clearances. The rule is broad in scope, and is intended to drive down instances of falsified data contained within product approval or clearance submissions to FDA. The FDA’s intent is to prevent “ambiguity in the current reporting scheme” that has caused confusion among sponsors and to “help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.”
Initial Analysis: This rule will effectively require the tactical implementation of certain compliance program elements within the oversight framework for human and animal studies. At a minimum, it should require additional training on the rule, and expectations regarding the prohibition of falsification of data under any circumstances. It should also lead to incorporation of personal certifications of data integrity on data submission, and individual acknowledgment of penalties for falsification of data.