Drugs

FDA Emphasizing Data Integrity: Attorneys

Attorneys John Hillebrecht and Rebecca McKnight (DLA Piper) say that after years of Justice Department focus on off-label promotion, kickbacks, and false claims, it appears that the focus may be shifting to current good manufacturing practice issues, especially data integrity. Writing in an online post, the two cite a 4/14 FDA draft guidance on data integrity and compliance with CGMP in which the agency says it has been troubled by the growing number of such violations that were increasingly being discovered during cGMP inspections.

While “data integrity” often is thought of as reflecting intentional misconduct and manipulation of data and records, the post says, some in the industry have argued that many violations are unintentional and due in part to expectations that were not detailed in cGMP regulations or past guidance documents.

“The draft guidance could be seen as addressing critics seeking greater clarity in the area head on, as it is largely written in straightforward language, mainly in a Q-and-A format, with several real-world examples that reflect record-keeping technologies used in the modern cGMP environment,” the attorneys write. “In this sense the draft guidance does not draw a new line in the sand so much as provide additional signage warning more precisely where FDA thinks the existing lines lie.”

The article also discusses how failure to comply with cGMP regulations can give rise to False Claims Act violations and discusses various types of enforcement action available to FDA.

“The draft guidance is a timely reminder that FDA is calling attention to data integrity in the cGMP context, and DOJ is likely paying attention,” the authors conclude. “Record-keeping may not be glamorous, but the draft guidance shouts loud and clear that ‘ensuring data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy, and quality of drugs’ and medical devices. Even the largest and most sophisticated companies may have potential issues lurking, and it would behoove all companies to discover them before the next time FDA is at the door.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome