FDA Seeks Public Comment on Draft Guidance for Priority Zoonotic Animal Drug Designation

On December 15, 2023, the United States Food and Drug Administration’s (“FDA”) Center for Veterinary Medicine (“CVM”) announced it had opened a docket to seek public comment on a new draft guidance entitled CVM GFI #283: Priority Zoonotic Animal Drug Designation and Review Process. The draft guidance is intended to assist sponsors seeking Priority Zoonotic Animal Drug (“PZAD”) designation for a new animal drug and to otherwise expedite the development and review of such drugs. FDA is accepting public comments on the draft guidance until February 16, 2024.

Background

The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, signed into law on March 27, 2020, added section 512A to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) to expedite the development and FDA review process for PZADs, a new category of new animal drugs. A PZAD is a new animal drug for which there is “preliminary clinical evidence” indicating that the “drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector-borne disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.” Section 512A(a). Section 512A(b) permits the sponsor to request a PZAD designation at the time of or any time after an investigational new animal drug (“INAD”) file is opened under section 512(j) or the sponsor files a new animal drug application (“NADA”) under section 512(b) or an application for conditional approval under section 571 for the drug.

Sections 512A(a) and (c) direct FDA to expedite the development and review of PZADs, including by determining within 60 calendar days after receiving a PZAD designation request whether a new animal drug qualifies as a PZAD. The law identifies actions FDA may pursue for the expedited development and review of an NADA or conditional NADA for designated PZADs, including taking steps to ensure the design of the clinical trials is as efficient as practicable, providing timely advice to, and interactive communication with, the sponsor, and implementing additional administrative or process enhancements.

Summary of Draft Guidance

The draft guidance describes CVM’s current thinking regarding the eligibility criteria for PZAD designation, the process for PZAD designation requests, and the process for expedited development and review of PZADs.

Eligibility Criteria for PZADs

A new animal drug must meet two substantive criteria to be designated as a PZAD. First, the new animal drug must be intended to prevent or treat a zoonotic (including a vector-borne) disease in animals. This includes products intended for use in an animal to prevent or treat a disease that could transfer to humans or a zoonotic disease-causing agent that can be transmitted to humans by contact with the animal or its environment, by ingestion of or exposure to animal products, or through insects or other vector species[1], or by treating a vector species. Second, the zoonotic disease must have, and be recognized as having, the potential to cause serious adverse health consequences for, or serious or life-threatening disease in, humans.

The draft guidance also states that only pioneer new animal drugs that may be approved or conditionally approved are eligible for PZAD designation and the drug’s indication should reflect the primary endpoint used to determine success in effectiveness studies in target animals, rather than how the product may prevent zoonotic diseases in humans. PZAD designations may be granted to multiple sponsors seeking approval for the same drug for the same or similar zoonotic disease indication(s) and a PZAD designation itself does not provide any marketing incentives (e.g., exclusivity) for the drug product.

PZAD Designation Requests

CVM reiterates that sponsors may request a PZAD designation concurrently with or after the INAD file’s opening or NADA’s filing, but recommends the sponsor submit a PZAD designation request to the INAD file. Before submission, a sponsor may request a meeting with CVM’s Office of New Animal Drug Evaluation (“ONADE”) to discuss the designation request.

The draft guidance advises that in the submission, the sponsor should address how the new animal drug meets the criteria for PZAD designation by providing the following information:

• Proposed conditions of use (i.e., drug identification, indication, species class, and dosage regimen);
• Method of administration;
• Mechanism of action (if known);
• A discussion of the potential for the new animal drug to prevent or treat a zoonotic disease in animals, including a vector-borne disease; and
• A description of the potential for the zoonotic disease to cause serious adverse health consequences for, or serious or life-threatening disease in, humans.

CVM will issue a letter informing the sponsor whether the drug is designated as a PZAD within 60 calendar days of the request.

Expedited Development and Review for PZADs

The evaluation process for PZADs will follow the new animal drug evaluation phased-review process outlined in GFI #132 Administrative Applications and the Phased Review Process. CVM confirms that PZAD applications will be subject to the applicable current Animal Drug User Fee Act (“ADUFA”) timelines, but also explains that, “with the goal of streamlining the process for PZAD products,” it will employ the following strategies:

1. Recurring informal meetings between CVM and sponsors so the sponsor can provide updates on drug development, address any changes to data submission timelines, and discuss questions and other issues that may result in minor amendments to the technical section submissions. These meetings will not replace pre-submission conferences or other formal meetings.
2. Pre-review feedback upon request, including high-level informal CVM feedback on draft submissions prior to the formal submission, such as guidance on gaps in the submission or answering questions on the appropriate level of detail for the presentation. Notably, CVM will “aim to” send sponsors a summary of its pre-review feedback within approximately 35 calendar days of receiving the meeting request, but will not issue a memorandum of conference (“MOC”) or acknowledgement letter for pre-review feedback.
3. Post-review feedback, to discuss informally the comments in CVM’s response letter and assist the sponsor to prepare a resubmission. CVM will not provide an MOC or acknowledgement letter for post-review feedback.
4. Stopping the review clock under certain circumstances, such as when the sponsor must submit additional information to complete a technical section or so CVM can accept a study without closing out the submission and initiating a new review cycle. When CVM stops the clock for a PZAD submission, it will provide to the sponsor a list of comments, to which the sponsor should respond within two weeks by either: (1) agreeing to submit an amendment with the requested information within 120 days; or (2) requesting that the clock be restarted because the sponsor does not agree to submit the additional information.

What Can You Do?

FDA encourages stakeholders to comment on the draft guidance. New animal drug sponsors may be especially interested in seeking further specificity and commitments on timelines and processes for expedited FDA review of designated PZADs, pre-submission meeting conferences and obtaining MOCs or other review documentation from CVM. The Agency currently is accepting comments on the draft guidance until February 16, 2024 through FDA’s docket (No. FDA-2023-D-3740).

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