Do We Really Need FDA’s Pre-Approval Inspections? FDA’s Own Data Say, No.
(Thursday, March 18, 2021)
Last year between March and December, FDA “reduced the need” for Pre-Approval Inspections (PAI) by more than 50%, and still met almost all its product approval timelines (93-100% of the times), raising the question if these inspections can be reduced for good. The year of the pandemic forced FDA to do an experiment otherwise impossible; to evaluate if alternate sources of information can negate the need for an onsite PAI, and it seems that FDA proved that the PAIs may not be as critical as we have been made to believe. The PAIs have been projected as an essential requirement for new product approvals. Under FDA’s pre-pandemic policies, all manufacturing sites involved in the production of a new product, whether a new prescription drug or a generic version, must be inspected before the approval decision was made. However, during the pandemic, FDA was forced to rely on internal records available from past compliance inspections, information from foreign regulators, and new records submitted by the applicants in lieu of inspections to decide if the product could be approved without a PAI. And for 93-98% of the original new drugs, and 91-94% of the generic drugs, lack of PAIs did not affect the final decision. This presents a strange conundrum. If this is true now, why was it not true before, and why does it need to go back to the pre-pandemic levels? FDA is being pushed by other agencies of the US government to fill the proverbial back-log of inspections but perhaps there is no back-log to start with. According to FDA’s own data, it was satisfied with the alternate sources of information for compliance verification and hence there should be no back-log. A back-log would indicate as if something was deficient in those approval decisions, but according to the FDA, there were no such deficiencies. Rarely did FDA had to delay an approval decision due to lack of the PAI. Perhaps it is the time to look at this differently. The PAIs create an immense pressure on the FDA to complete its facility inspections in a short time creating logistical challenges and costs. By permanently reducing PAIs, FDA could use the extra resources for surveillance inspections and targeted audits thereby still securing the supplies. FDA should use last year’s record to make a point that PAIs are probably an antiquated policy which should be downgraded from the pedestal they are perched on and the saved resources used for other activities that will truly assure product safety for the consumers.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
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