How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors

How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first enacted the Generic Drug User Fee Amendment (GDUFA I) in 2012. After negotiations between the FDA and industry representatives, and with input from public stakeholders, Congress mapped out the concept that generic drug sponsors would pay a user fee upon submission of an ANDA, and in return the FDA would make sweeping commitments to improving the ANDA review process and provide a mechanism for quickly moving ANDAs through the regulatory pathway.

Prior to GDUFA I, the FDA had as many as 2,500 backlogged ANDAs at any given time, which stretched the median time for generic drug approvals to 31 months or more. The primary goals of GDUFA I were to put the FDA’s generic drug program on firm financial footing and ensure timely access to safe, high-quality, and affordable generic drugs.

Essentially, GDUFA I empowered the FDA to assess user fees to fund critical and measurable enhancements to the performance of the Agency’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. This has resulted in hiring more reviewers and investing in better technology, allowing the Agency to better carry out its responsibilities.

GDUFA II Performance Goals and Procedures

GDUFA II was signed into law in 2017, reauthorizing GDUFA I for fiscal years 2018 to 2022.  The ongoing goal is still to facilitate timely access to high-quality, affordable generic medication.

Under the law, the FDA agreed to certain review goals that were no longer tied to a complex tiered system. These review goals are based in part on whether the ANDA is subject to standard review or priority review, and whether the amendment is classified as major or minor. Further, the review goals consider whether the priority submission requires a preapproval inspection, and if so, whether the applicant submitted a timely, complete, and accurate pre-submission facility correspondence. Prior to GDUFA II, Sponsors could not meet with FDA’s Office of Generic Drugs (OGD). However, under the new legislature, the Pre-ANDA program was established, allowing for Sponsors of complex generic products to meet with OGD.

GDUFA II commits the FDA to the following performance goals and procedures relative to original ANDAs and ANDA Amendments:

1. Review and act on 90% of standard original ANDAs within ten months of the date of ANDA submission.
2. Review and act on 90% of priority original ANDAs within the applicable review goal.
3. Review and act on priority original ANDAs within eight months of the date of ANDA submission, if the applicant submits a Pre-Submission Facility Correspondence two months prior to the date of ANDA submission and the Pre-Submission Facility Correspondence is found to be complete and accurate and remains unchanged.
4. Review and act on priority original ANDAs within ten months of the date of ANDA submission if the applicant does not submit a Pre-Submission Facility Correspondence two months prior to the date of ANDA submission or facility information Changes or is found to be incomplete or inaccurate.
5. Review and act on 90% of standard major ANDA amendments within the applicable review goal.
6. Review and act on standard major ANDA amendments within eight months of the date of amendment submission if preapproval inspection is not required.
7. Review and act on standard major ANDA amendments within ten months of the date of amendment submission if preapproval inspection is required.
8. Review and act on 90% of priority major ANDA amendment submissions within the applicable review goal.
9. Review and act on priority major ANDA amendments within six months of the date of amendment submission if preapproval inspection is not required.
10. Review and act on priority major ANDA amendments within eight months of amendment submission if (i) preapproval inspection is required and (ii) applicant submits a Pre-Submission Facility Correspondence two months prior to the date of amendment submission and the Pre-Submission Facility Correspondence is found to be complete and accurate and remains unchanged.
11. Review and act on priority major ANDA amendments within ten months of amendment submission if (i) preapproval inspection is required and (ii) the applicant does not submit a Pre-Submission Facility Correspondence two months prior to amendment submission, or facility information Changes or is found to be incomplete or inaccurate.
12. Review and act on 90% of standard and priority minor ANDA amendments within three months of the date of amendment submission.

Ultimately, the practical impact of GDUFA II is that generic drug sponsors can expect to have their ANDAs reviewed and responded to within ten months of submission. If the review does not result in approval, the sponsor will receive a Complete Response Letter (CRL) which compiles a list of major issues the Agency has found with the application. The sponsor must rectify each deficiency before resubmitting the amended ANDA for another review cycle.

GDUFA’s Success

Having access to funding beyond the traditional budget appropriations from Congress has helped the FDA eliminate its ANDA backlog. This has allowed the Agency to hire additional staff and better allocate review activities.  As a result, the FDA has recently experienced record generic drug approval rates.

ProPharma’s Role in Your Generic Drug Program

The rising rate of ANDA recipients does not mean that, as a sponsor, you should be any less vigilant throughout the application process. While approximately 60% of files were ultimately approved in 2017, the key to maximizing the success of your generic drug program is to strive to get it “Right the First Time.”

When you work with ProPharma, you can count on the technical knowledge of our team members. Based on our broad experience with generic drugs and understanding of the FDA’s review standards, we will help you compile an ANDA that has the highest possible chance of approval. The FDA has made their commitment to reviewing your application in a timely manner; it’s up to you to present them with an application that’s outstanding. In addition to our extensive experience helping clients compile and submit successful ANDA submissions, we have also help clients prepare for and conduct meetings with FDA under the Pre-ANDA program. Regardless of where you are in the process of developing of your generic product, we can help with all of your regulatory needs.

Contact our team of experts today and find assistance on GDUFA and on getting your generic drug approved.