Obtaining Early Regulatory Advice — INTERACT Meetings

Part 1
Author: Dr. Cheryl L. Rowe-Rendleman

In the United States, “biologic products” are subject to a different premarket pathway than products regulated as “drugs”. This 3-part blog series describes practices of the U.S. Food and Drug Administration (FDA), across key practices and processes for market approval of biologic products.

Part 1: Obtaining Early Regulatory Advice — INTERACT Meetings (October)
Part 2: Conducting Trials (November)
Part 3: Data information and disclosure (December)

Obtaining Regulatory Advice
In the US, biologics are regulated by the FDA Center for Biologics Evaluation and Research (CBER). The Center is responsible for reviewing and regulating biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER also regulates selected in vitro diagnostics and devices that manufacture a biologic at the point of care, as well as a small number of drug products related to blood banking or cellular therapies.

When seeking initial advice about a biologic, sponsors of novel products have to decide which of the 3 offices within CBER would be most helpful.

Table 1. CBER Review Offices

Product Classification	CBER Office for Review
vaccines, allergenic products (e.g. patch tests), infectious disease vaccines, live biotherapeutics (including probiotics)	Office of Vaccines Research and Review (OVRR)
cell, tissue and gene therapies, therapeutic vaccines for various disease indications	Office of Tissues and Advanced Therapies
blood donor screening assays and retroviral diagnostic tests	Office of Blood Research and Review

Within each office there are divisions and advisory committees that can help an individual sponsor get started with early regulatory advice on a biologic-led product. Most of these meetings are held virtually or resolved with written responses from the FDA. In rare instances the meetings with the FDA are held face-to-face.

Early Advice

In October 2023, FDA issued a draft update of the 2017 guidance for formal meetings with sponsors or applicants of PDUFA products [1,2]. A “PDUFA” product is a product that is subject to the “Prescription Drug User Fee Act”. These fees allow the FDA to support resources to process the review of drug and biologics applications. In the 2023 guidance, FDA expanded the types of meetings that sponsors could request.

The new TYPE D meeting is a focused FDA interaction comprised of no more than 2 questions to discuss issues at key decision points. Typically input will be needed from no more than 3 divisions to resolve a critical regulatory crisis. It may take as long as 50 days to receive a written response to questions posed in a Type D meeting.

INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER producTs) meetings have been used by CBER since 2017. Now this meeting type has been expanded to drugs and the Center for Drug Evaluation and Research (CDER). An INTERACT meeting is intended to facilitate IND-enabling efforts when the sponsor is facing a novel, challenging issue that might otherwise delay progress of the product toward entry into the clinic in the absence of this early FDA input. This may include questions for which there is no existing FDA guidance or other information that a sponsor might reference. Other questions 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. According to the 2023 Draft update, one might expect a written response from the FDA within 75 days of a formal request to the FDA.

Given these timelines–it is important that sponsors plan ahead and use these meetings wisely. Premeeting preparation of questions and background materials is critical for productive discussions with the FDA. The meeting packages should be organized, paginated, and indexed to help the reviewers navigate across sections. Since recording or videotaping of FDA meetings is prohibited by law, sponsors should always bring a scribe or someone to take notes at these meetings.

References

1. Formal Meetings between FDA and Sponsors or Applicants for PDUFA Products. Guidance for Industry. US Department Health and Human Services (December 2017). www.fda.gov/media/109951.
2. Formal Meetings between FDA and Sponsors or Applicants for PDUFA Products. Draft Guidance for Industry. US Department Health and Human Services (October 2023). www.fda.gov/media/172311.

About the Author:
Omar Consulting Group, LLC

Dr. Cheryl Rowe-Rendleman serves as CEO and Managing Consultant at Omar Consulting Group, LLC. (Princeton NJ ǀ Durham, NC). Since 2006 Omar (ophthalmic management and research) specializes in regulatory and clinical consulting for drugs and devices in the US, Europe, and China. At Omar, Cheryl specializes in taking companies to the FDA and plays a leading role in developing successful paths to market and acquisition for emerging biotechnology.