15 Years!
This past week FDA commissioner Dr. Califf was visiting India to celebrate 15 years since the establishment of the New Delhi office, a place that holds special meaning for me. As a result, I was interested in the details of the visit, and one particular activity caught my attention: Dr. Califf’s 25 minute sit-down interview with CNBC’s “The Medicine Box” on September 29th. I was impressed with the direct and meaningful nature of the questions. It was evident that the journalist was well aware of the current compliance environment, and unafraid to ask tough questions! The interview covered several hot topics:
Unannounced Foreign Site Inspections: my take on the interview is that we can expect these to continue and most likely be expanded, especially because Dr. Califf actually states “I think a mixture of announced and unannounced is important, and you will see more unannounced inspections.” Essentially, no firm should now be surprised if an FDA Investigator shows up in a foreign facility without notice, especially anywhere the FDA has a permanent presence (EU, South/Central America, Asia), which makes the logistics of such a visit easier to manage.
Re-Shoring Essential Manufacturing Capabilities: FDA has little influence on the factors that could encourage re-shoring, as a science-based public health agency. Economics has a large role to play here, among other things outside of the FDA’s control.
Emerging Concern with Clinical Data Integrity: Dr. Califf himself inserts the “including clinical” comment several times as a concern, including when responding to questions about post-COVID compliance. This is notable considering the recent press regarding the reliability (or not) of clinical trial data being used to approve drug applications. This is a worldwide concern and potential nasty can of worms about to be opened. Be prepared for a crackdown on enforcement of good clinical data governance. See my earlier blog post for an evaluation of the recent European guidance for GCP data management, which provides excellent advice and is largely harmonized with previously published commercial DI guidance.
Maturity: Dr. Califf emphasizes a focus on the transition to digital, which could aid the agency in determining when and where to perform inspections, as well as specific areas of interest in which to focus during those inspections. We are likely some years away from such a scenario, but the comments fit in quite nicely with the recent FDA update earlier this month to the QMM journey and potential rewards for Quality investments, which they have been pushing hard the past few years. In parallel to the discussion on digital transformation, there is an emphasis on employee training and empowerment, a necessary ingredient for true Maturity. Industry should be prepared for a change in tactics when it comes to the FDA evaluation of employee training programs, with an emphasis on the ability to demonstrate training effectiveness, rather than simply providing evidence that training was provided.
I could keep going here on the link between the interview and industry’s QMM journey – but will save that for the next Blog post, stay tuned!
Pete
