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# FDA Likes New User Fee Interactions, and Resources: Hearing
- URL: https://www.fdaweb.com/fda-likes-new-user-fee-interactions-and-resources-hearing/
- Published: 2022-02-03T12:00:00.000Z
- Updated: 2026-09-14T17:31:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151078

FDA says that the most important enhancements in the Prescription Drug User Fee Act (PDUFA VII) reauthorization are a new early interaction meeting for getting feedback on development programs, a new program on drug supplemental submissions, and increased staffing to address the increasing review obligations of cell and gene therapy products. Testifying at a 2/3 House Energy and Commerce subcommittee hearing on drug/biologic user fee reauthorization, CBER director **Peter Marks** highlighted a few of the enhancements the program will begin seeing when the industry- and FDA-negotiated five-year agreement goes into effect 10/1.

“Enhanced interactions give us the opportunity to provide more guidance to sponsors, improving the potential for first-cycle approval and giving safe and effective drugs to patients sooner,” Marks said in his opening remarks. “These interactions also enable sponsors to incorporate the advances in regulatory science into their development programs, expediting drug development and facilitating timely regulatory decisions.”

The new INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products) meeting, according to the new PDUFA [commitment letter](https://www.fda.gov/media/151712/download?ref=fdaweb.com), “facilitates Investigational New Drug Application (IND) enabling efforts where a sponsor is facing a novel, challenging issue that might otherwise delay progress of the product towards entry into the clinic in the absence of this early FDA input. There would also be a new follow-up opportunity to pose clarifying questions after meetings or a written-response-only communication.”

Under INTERACT, the meetings are intended for novel questions and unique challenges in early development, the agency says. “The issues typically relate to IND requirements for example: questions regarding design of IND-enabling toxicity studies (e.g., species, endpoints), complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of cutting-edge testing methodologies,” it says.

Another FDA high-interest area in the PDUFA reauthorization, according to Marks, is the “Split Real Time Application Review Pilot Program” for efficacy supplements that meet specific criteria. Applications that move into the pilot program will be submitted in a “split” fashion, in two parts with each component about two months apart. “The goal is to shorten the time from the date of complete submission of the application to the action date,” FDA says. Marks said these supplements could be approved at least a month earlier than current reviews permit.

Marks was also excited about an “incremental increase in our cell and gene therapy staff which is desperately needed to allow those products to move ahead and progress in a very timely manner.” In his testimony, he said FDA has experienced exponential growth in cellular and gene therapy submissions over the past seven years with over 1,993 active, development programs. “We have seen a sustained increase in development program activities, including an 85% increase in original IND receipts, a 139% increase in IND amendment receipts, and a 158% increase in formal meeting requests.”

Marks said the user fee agreement will “support development of multiple guidances, numerous public meetings to examine new technologies and approaches, patient-focused drug development meetings to better understand patient perspectives on gene therapy products, and public outreach to facilitate product development and approval. In addition, if the negotiated commitments are adopted, new allergenic extract products will be included in PDUFA VII, and the program will provide needed resources to facilitate the development and approval of new therapies, including those for food allergens, which constitute most new allergenic products under development.”

PDUFA VII recommends increasing fees to fund 352 new staff and to support critical investments in areas such as data IT modernization, according to Marks’ testimony. The new staff and investments are scheduled to phase in over the five-year user fee period, and they will focus on improving pre-market review processes and procedures; enhancing regulatory science to expedite drug development; enhancing regulatory decision tools to support drug development and review; and continuing enhancement and modernization of the drug safety system, among other areas.

Addressing the generic drug user fee reauthorization, CDER director **Patrizia Cavazzoni** told the hearing that the generic program is really focused on increasing the efficiency of the review process and “trying to make the most out of every single review process so that we can increase the proportion of generic drugs that are approved with only one cycle of review. And to that effect, there are a number of incremental elements in the proposals to achieve those goals. The other big focus in the generic program is enhancements to facilitate and accelerate the development of complex generics, which are those generic drugs that are more difficult to make. And to that effect the agreement includes commitments to issue product-specific guidances to increase communication with the manufacturers who are developing these complex generics, and also to ensure that there is communication in situations where we have to issue a complete response letter.”

She said that the average first-cycle approval rate remains around 15%. And while progress is improving in the approvals of complex generics, about 30% of active reference products, that do not have generic competition, are complex products.

Regarding the biosimilar user fee reauthorization, Cavazzoni said the focus of the proposal is on increasing the efficiency of biosimilar development and review and interchangeable biosimilars, which are those biosimilars that can be switched at the pharmacy like generics. She pointed to last year’s approval of an interchangeable insulin to illustrate gains the agency is making in this area. The reauthorization also proposes a regulatory science pilot program that will focus on two demonstration projects: (**1**) advancing the development of interchangeable products, and (**2**) improving the efficiency of biosimilar product development.

To read FDA’s prepared testimony, click [here](https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Witness%20Testimony%5FCavazzoni%5FMarks%5FHE%5F2022.02.03.pdf?ref=fdaweb.com).