FDA official says data integrity issues are the main reason for ANDA delays
BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, according to Darby Kozak, deputy director of the Office Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER).Kozak made these remarks during the agency’s Generic Drug Forum (GDF) on 9 April, and said the information was gleaned from the results of a recent transparency pilot.
His presentation addressed three key aspects of the generic drug program: the current status of generic drug approvals, some notable approvals, and new strategies the agency is using to expedite the development of generic drugs. Prior to his presentation, FDA officials said they would not discuss the recent layoffs at the agency during the meeting.
In calendar year 2024, FDA approved 900 ANDAs, which were either granted approval or tentative approval. This included the approval of 92 complex generics, 76 first generic drug approvals, and 132 generics designated as competitive therapeutic alternatives. One of the notable first generics approved was for bupivacaine liposomal injection.
Kozak explained that these figures do not include OGD’s handling of “thousands” of post-approval supplements, as well and its handling of controlled correspondence and suitability petitions.
To expedite the ANDA review process, OGD launched a six-month transparency pilot in October 2024 to enhance communications and transparency with generic drug applicants.
The pilot was developed as part of FDA’s commitments under the Generic Drug User Fee Amendments (GDUFA III). Section II B.6 of the commitment letter states that “if an RPM [regulatory project manager] learns that FDA is likely to miss the goal date for an ANDA, the RPM will notify the applicant of the delay in taking an action, identify the general reason for the delay including the outstanding discipline(s), if any, and the estimated time for FDA’s action on the application.”
He noted that these delays impact only a fraction of the actions FDA takes each year.
The pilot showed that the majority of the delays, 75%, were attributed to data integrity issues, while the remaining 25% were due to scientific or regulatory reasons.
Kozak said that “data integrity issues were the leading cause of an ANDA missing its goal date by more than 60 days.”
He reminded companies that “FDA requires high-quality data that is accurate, consistent, and reliable. FDA and OGD require industry to maintain the integrity of data throughout the product lifecycle.”
Kozak pointed to a recent warning letter to Raptim Research, an Indian contract research organization, to illustrate the agency’s concerns with data integrity. The letter found that bioequivalence data may have been falsified, and FDA has said that drugs that relied on bioequivalence studies conducted by Raptim Research will need to repeat those studies. (RELATED: FDA uncovers ‘significant’ data integrity concerns at Indian CRO, Regulatory Focus 2 April 2025).
Kozak recommended sponsors consult FDA’s April 2024 draft guidance on achieving data integrity for in vivo bioavailability (BA) and bioequivalence (BE) studies.
One of his requests is that the industry ensures it is submitting applications with “accurate, consistent, and reliable data.”
“Although uncommon compared to the number of generic drug applications approved and marketed every year, data integrity affects everyone in the generic industry and the generic program. Questions of data integrity erode public confidence in all medications…It consumes vital FDA resources to address these issues, these are resources that we otherwise could devote to other issues,” he said.
