Industry Comments on FDA’s Draft Data Integrity Guidance Reveal Regulatory Challenges

The number and depth of comments FDA received on its new draft data integrity (DI) guidance, and the dialogue the guidance has generated at recent public forums, indicate the high profile nature, dimension, and complexity of the challenges regulators face in overseeing and seeking to advance industry DI practices.

The comments center around industry concern that the expectations the agency is conveying in the guidance are as clear, viable, risk-based and globally harmonized as possible, and not overly restrictive or proscriptive.

The comments are generally supportive of the FDA draft, recognizing the critical nature of assuring data integrity to the regulatory process and the importance of substantive guidance. The concerns expressed, however, indicate that the regulatory balancing act is not an easy one, and that care needs to be taken to ensure that the expectations actually drive the desired behaviors and outcomes.

FDA released its draft “Guidance for Industry” entitled “Data Integrity and Compliance with CGMP” in April with a 60-day comment period, which closed July 14th. Over 50 separate responses were received.

Among the organizations providing in-depth comments were ISPE, PDA, PhRMA, GPhA, the Personal Care Products Council, and the Society of Quality Assurance. A comparison of the association comments shows a common focus on clarity, viability, risk orientation and global consistency as key criteria in evaluating the draft’s content and wording.

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