US FDA official emphasises the need for strong quality culture amidst growing data integrity issues in pharma

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Sarah McMullen, the Country Director at the US Food and Drug Administration (FDA), recently shared insights into the growing concerns about data integrity issues within pharmaceutical facilities. While acknowledging the increased identification of such issues, she emphasised the need for a strong quality culture and proactive measures to address these challenges.

McMullen highlighted that data integrity issues are not isolated incidents but are found throughout manufacturing and laboratory facilities. She emphasised the importance of fostering a robust quality culture within organisations.

“What we want to see from companies is not just a quality motto, which most companies should have and do have; we want to see them empower their employees at every level to make the right decisions regarding product quality and to have the accountability to follow that up. And so that’s maybe one of the pieces that we think could solve some of these data integrity issues,” McMullen said in an interview with CNBC-TV18.

Discussing the broader compliance landscape, McMullen noted an overall improvement in compliance within the pharmaceutical industry in India. Post-COVID, the FDA conducted a significant number of follow-up compliance inspections, followed by an increased focus on surveillance inspections. The number of surveillance inspections conducted in the past year more than doubled compared to the previous year, contributing to enhanced compliance rates, she added.

While it remains challenging to ascertain whether data integrity issues existed before but went unnoticed, McMullen acknowledged the current efforts to discover and address them. The FDA aims to take concerted actions to rectify these issues and ensure the integrity of data across pharmaceutical facilities.

McMullen emphasised that data integrity is not limited to specific locations and urged the entire pharmaceutical industry to engage in improving practices. Recognising the global nature of the issue, she called for collaborative efforts to enhance data integrity standards and practices worldwide.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow