The Generic Drug Forum was a two-day event held on April 8-9, 2025. This was one of the first public engagements that the Office of Generic Drugs (OGD) participated in since the current administration’s pause on FDA communications was announced in February 2025. There were many interesting sessions that presented an enormous amount of content. Some of it was Generic Drugs 101, but there were plenty of “I didn’t know that” pieces of information or clarifications that were of particular interest. We blogged about one such item on Imminent Action, its meaning and metric, here. In addition, we presented some information on the FDA’s progress in meeting GDUFA goal dates.

Today, I want to point out some information on approval times for generic products that was presented by Darby Kozak, Ph.D., Deputy Director, OGD. Also, there was a bit presented relating to data integrity (DI); while hardly a new issue for the generics industry, it is clear that the DI problem has not disappeared.

Looking at approval times, Dr. Kozak indicated the great strides that the OGD has made in the reduction of time to approval of ANDAs. The following chart provides median approval times for the 5%, 10%, 25%, and 50% of applications in the cohort years since the first year of the GDUFA program. (Please note that data is not yet available for the 50% median in 2023.)

Presentation of this specific data set in this particular manner, broken out by cohort year (i.e., the year in which the application was accepted for receipt), is not something that the industry typically gets a glimpse of. This also means that, when looking at cohort-year results, the data will change when more of the applications submitted from that cohort year gain approval. The picture does, however, look good. The type of data we’re used to seeing reported is mean and median approval data by quarter for all applications approved, regardless of the cohort year in which they were submitted. This information usually comes from the monthly Generic Drugs Program Activities Report, in which the mean and median approval information is provided on a quarterly basis. For instance, see the chart below from FY 2023, the first time this information was provided in the monthly report.

As you may note, the numbers are quite a bit different than the numbers in Dr. Kozak’s slide and that is because these numbers include older applications that are being approved, perhaps two to three or more years after their cohort year. As noted in the Approval Time by Quarter report, the data in this chart represents “Mean/Median AP/TA calculated as the difference between the first full approval (AP) date or the first Tentative Approval (TA) date and the date the original application was accepted for filing divided by the average number of days per month (30.4375). The unit for each of these metrics is months.” A bit of apples and oranges for sure, but Dr. Kozak’s chart does show the improvement in approval times for fresh applications in the newer cohort years as well as a favorable trend over time.

Shifting gears, Dr. Kozak also addressed the age-old problem of DI and noted that DI issues were the main reason for the OGD missing goal dates. He also indicated that investigating DI issues utilizes a significant amount of the OGD and FDA review resources, which could otherwise be used for other review activities. Dr. Kozak noted that assuring the integrity of the data in applications is ultimately the responsibility of the ANDA applicant. He further stressed that applicants should ensure that all of the contractors associated with the filing, whether involved in manufacturing, bioequivalence testing, laboratory testing, etc., have robust quality assurance programs and suggested that applicants “not use a supplier with questionable quality practices.”

As there have been notable cases (see previous posts here, here, and here) where DI issues associated with the data from certain CROs were found to impact multiple applicants and ANDAs, Dr. Kozak highlighted the 2024 Draft Guidance titled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies as a good guidance document for industry to follow while reminding applicants that they have a responsibility to “inform the FDA of any data quality concerns promptly.”

We’ll be back with more tidbits from the Forum later this week!