It’s been about six months since I last checked in with news from the Pharma & Biopharma Outsourcing Association (PBOA). At the time, the PBOA was immersed in negotiations with FDA and other industry groups for the reauthorization of the Generic Drug User Fee Amendments (GDUFA). Because negotiations were ongoing, I couldn’t discuss how they were progressing—beyond the need for confidentiality, it was also a very fluid process.

Now, I’m happy to report, industry’s negotiations with FDA have concluded! However, I still can’t go into much detail, pending FDA’s disclosure of the proposed five-year reauthorization model. In mid-September, the agency did reveal some details of the proposal in a Federal Register notice, in advance of an October public meeting for comment prior to submission to Congress. Much of the FR notice discussed operational improvements for GDUFA II, regarding timelines for first reviews of Abbreviated New Drug Applications (ANDAs), a priority model that would shave two months off of the first review cycle—provided the applicant provides a pre-submission facility correspondence two months prior to ANDA submission—and consolidation of all ANDAs and ANDA amendments in a way that will streamline the program’s administration.
The agency also proposes to communicate outstanding facility issues more quickly to ANDA filers; PBOA worked to make sure they’ll respect the confidentiality of CMO facilities and their clients.

CMOs and CDMOs may be less directly impacted by these enhancements than the ANDA filers are, but PBOA was glad to be part of the conversation throughout the process and to develop a better understanding of the bottlenecks in ANDA reviews, the dynamics between the generics industry and the FDA, and the ways in which facility inspections are changing under FDA’s inspectorate overhaul and risk-based model.

PBOA’s primary goal at the negotiations was to rework the GDUFA funding model into a fairer, more equitable system that would provide FDA with sustainable and predictable resources for the GDUFA program over the next five years. Again, I can’t go into detail—size of the program and percentages allocated to each revenue source—but the FR notice does mention several key proposed changes to the fee structure that should go a long way to achieving our goal:

1. An annual “program fee” for ANDA-holding entities — ANDA sponsors will pay a tiered fee based on their total number of approved ANDAs.
2. “No fee until approval” — A facility listed only in pending ANDAs will not be charged a facility fee. For CMOs, that means no paying annual facility fees on a facility that’s waiting for a first ANDA approval.
3. CMO Final Dosage Form (FDF) facilities will pay one-third of the fee paid by non-CMO FDF facilities.

These are significant changes to the program, and they were the result of extensive negotiations among industry groups and FDA. I believe they’ll create an environment where CMOs and contract packaging organizations (CPOs) can compete more effectively in making generic drugs for sponsors. The reduced CMO facility fee and the elimination of fee-while-pending, which has resulted in CMOs paying multiple years of facility fees without a revenue-generating product at their sites, will benefit our sector over the next five-year GDUFA period, pending Congressional approval, and help create a more robust, flexible manufacturing network for generic drugs.

We couldn’t have achieved this without the support of PBOA’s member companies and the CMO/CDMO sector overall. At the same time, it required a leap of faith on the part of FDA to bring us into the negotiation. As the new kids at the table, PBOA was treated respectfully by the other participants, and I believe that this experience, over and above the immediate changes to the GDUFA program, will help our sector work more closely with industry and FDA. Our team’s professionalism and diligence not only helped us achieve our goals, but also demonstrated to the FDA that PBOA is a group they can work with in future.

In fact, our work on GDUFA helped bring about a very positive meeting between the PBOA and Janet Woodcock, M.D., the director of FDA’s Center for Drug Evaluation and Research (CDER), and her team. I’ll tell you more about that next time I check in.

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Gil Roth
President, Pharma & Biopharma Outsourcing Association

Gil Roth is the president of the Pharma & Biopharma Outsourcing Association (www.pharma-bio.org), a non-profit trade association representing the regulatory and legislative interests of CMOs and CDMOs. He can be reached at gil.roth@pharma-bio.org.