Industry wants more transparency, dedicated program for complex generics in GDUFA IV

The next iteration of the Generic Drug User Fee Amendments program should focus on enhancing communications between the US Food and Drug Administration (FDA) and generic drug applicants, industry commenters said. Additionally, some commenters said there should be a dedicated program for complex generic development as part of GDUFA IV.

The recommendations were made by members of the generic drug industry as it begins the negotiation process to renew the program for fiscal years 2028 to 2032 and followed a public meeting on GDUFA reauthorization last month.

In its meeting announcement, FDA requested that stakeholders evaluate the overall performance of the GDUFA program and to suggest and changes to the current fee structures. They were also asked to identify which aspects of GDUFA should be retained, modified, or discontinued, and to suggest any new features the FDA should consider adding to the program.

Overall, the industry expressed strong support for the user fee program. The Association for Accessible Medicines (AAM) said that “GDUFA is a success story and one we are proud to continue building together. GDUFA is a vital tool that supports the development of generic medicines for industry and enables the FDA to efficiently assess and approve them. In FY 2024 alone, FDA approved over 700 generic drugs, including more than 100 first generics. These represent critical opportunities to lower costs for patients and strengthen the resilience of our supply chain.

Generic drugmaker Viatris agreed with AAM, stating, “By and large, GDUFA is an indispensable program that supports the assessment of generic drugs and ensures patients have access to affordable treatments…. Overall, more efficient communication between FDA and [abbreviated new drug application] ANDA applicants would reduce the number of assessment cycles and foster the development of complex generic products that could help transform the health of the American people.”

Improved communications

Despite the program’s successes, AAM complained that first-cycle approval rates have not improved to the group’s satisfaction. “First cycle approval rates have never exceeded 20% since FDA began reporting the rates in 2018, and they actually fell from 18.9% in fiscal year (“FY”) 23 to 17.6% in FY 24,” AAM wrote, noting that first cycle approvals for new drugs and biologics are much higher.

AAM said that improved transparency and communication at various stages of the submission could improve the situation and that some of its members felt that “some meetings fall short of providing the intended transparency concerning FDA’s expectations, and they offer limited opportunities for meaningful, substantive dialogue.

The group noted that the industry has seen “inconsistent and ineffective” communication with applicants regarding review delays. The group stated that applicants often receive letters and requests from FDA for issues that could have been address earlier in the process.

Viatris emphasized the need for the FDA to enhance the GDUFA process by improving communication for IRs and DRLs. FDA should work to “improve communication practices for information requests (IRs) and discipline review letters (DRLs) to avoid delays, including unnecessary goal date extensions.”

Indian generic firm Aurobindo said that to avoid unnecessary delays, the agency should issue DRLs upon completion of individual discipline assessments, rather than waiting for all review components to conclude prior to communication. “This approach would support more timely and transparent engagement between the Agency and applicants, allowing for early resolution of issues and potentially reducing the likelihood of Complete Response Letters (CRLs) for matters that could be effectively addressed through Information Requests (IRs).”

Explain reasons for rejecting DMFs

In connection with this recommendation for improving communications, there were also requests for the FDA to explain to ANDA holders the reasons for any rejected DMFs.

Aurobindo said that “we would like to respectfully express a concern regarding the notification of deficiencies—particularly those related to Drug Master Files (DMFs) and quality assessments. In certain instances, we are informed that a deficiency exists, yet the specific nature of the issue is not disclosed. This lack of detail can hinder our ability to promptly investigate and resolve the matter, potentially resulting in unnecessary delays in the review and approval process.”

The company suggested that FDA consider providing a general categorization of the deficiency, for example, whether the deficiency is related to stability data, the manufacturing process, or drug specifications.

“Such transparency would significantly improve our ability to respond effectively and support the overarching goal of bringing high-quality generic medicines to market efficiently,” the company said.

AAM also weighed in and agreed with the other respondents. “Applicants and DMF holders cannot track the progress of the DMF review because of a lack of transparency. FDA provides no information about when it initiates a review or whether deficiencies have been identified before the formal action letter,” it said.

Dedicated program for complex generics

Several respondents also suggested that GDUFA IV have a dedicated program for reviewing complex generics to avoid review delays.

AAM said that “despite the GDUFA III efforts, development of complex generics continues to be delayed, and first-cycle approvals of these products are rare in part because of limitations placed on the enhancements. For example, under GDUFA III, only a subset of complex generics qualifies for Product Development and Pre-Submission Meetings, and FDA commits to provide only limited meeting opportunities before submission.”

Teva also suggested a dedicated complex generic development program. Teva said that “potential learnings from the Biosimilar Biological Product Development (BPD) program could be leveraged and adapted to support development and approval of complex generic products in a dedicated program. Similar to the BPD fees, such a program could be funded by a dedicated fee for participation in the program to ensure the Agency has adequate resources to support such program for all complex generic products without need to limit participation to select few programs.”

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Industry wants more transparency, dedicated program for complex generics in GDUFA IV

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