U.S. and European regulators are giving a clear message at public meetings and in their written guidance that up-front communication with the agencies about data integrity lapses that a company has uncovered is critical to maintaining trust and avoiding more serious enforcement repercussions later.
Industry, on the other hand, is pointing to the wide spectrum of DI problems that may occur and questioning where the reporting threshold should be placed. Industry is also probing the regulators on their expectations for what a risk-based response should look like internally, depending on what is known about the problem at hand.
The response issue has been prominent in the industry/regulator dialogue on data integrity at recent forums and was highlighted in the comments that FDA received on the draft DI guidance it released in April.
Pushing the topic onto the front burner are the high stakes involved for companies in meeting the regulatory expectations in the DI context. The stakes are high for the patient, as well, if product quality is jeopardized and/or drug shortages result.