Drugmakers seek details on INTERACT meetings

Sponsors of drug and biologic products are asking the US Food and Drug Administration (FDA) for more specifics on how agency officials will decide whether to green light requests for in-person consultations and INTERACT (Initial Targeted Engagement for Regulatory Advice on CDER and CBER Products) meetings.

The comments are in response to FDA’s draft guidance on formal meetings between sponsors or applicants developing products regulated by either the FDA’s Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The guidance, issued in September 2023, incorporated provisions of the Prescription Drug User Fee Act (PDUFA VII). (RELATED: FDA guidance on formal meetings adds new categories, timelines, Regulatory Focus 21 September 2023)

The guidance adds two new types of meetings: a Type D meeting to address a narrow set of issues at key decision points and the INTERACT meeting for novel products and development programs. It also defined a “formal meeting” as including in-person face-to-face, virtual face-to-face (video conference), teleconference, and written response only (WRO) formats.

INTERACT meetings

The Biotechnology Innovation Organization (BIO) praised FDA for adding the Type D and INTERACT meetings in a timely manner, following the passage of PDUFA VII. However, they noted that sponsors “continue to experience considerable variation across review divisions and centers” in both the types of meeting formats that are available and the ability to receive timely clarifications.

BIO requested that FDA provide more specifics about when it is likely to grant in-person meetings versus other meeting formats. The group also commented that sponsors have noticed a shift toward the agency using WRO instead of face-to-face meetings, even for complex topics.

“While we recognize that the FDA applies the same level of consideration to WRO responses as it does to live meetings, we note that WRO limits the ability for dynamic exchange which is particularly important when Sponsors are employing novel approaches. We encourage FDA to outline the criteria applied in determining the appropriateness of WRO,” BIO wrote.

Additionally, BIO asked FDA officials to provide more examples of when it is appropriate to request a Type D meeting and to clarify the difference between an INTERACT and pre-IND meeting.

Gilead Sciences also asked for clarification of the criteria for granting INTERACT meetings and what types of issues are more appropriate for a pre-IND meeting. The company asked FDA to provide hypothetical examples of INTERACT meetings granted by CDER.

The draft guidance states that INTERACT meetings should be requested to address questions for “novel products and development programs that present unique challenges in early development” for which there is not existing guidance or other written materials from the agency. Gilead commented that this standard was “overly restrictive” and requested clarification and examples of how FDA was defining “novel.”

Meeting formats

On the topic of meeting formats, Gilead asked for more information about who would be considered a “core participant” for video conference meetings and would need to have their cameras turned on during meetings. The company also requested that FDA address when screen sharing can happen in a video conference. “Since it is difficult to prospectively anticipate the details of meeting discussions, screen sharing would allow for sharing of content not previously supplied within the meeting package,” Gilead wrote.

Gilead also noted that supplements and post-approval changes are not specifically addressed in the guidance and requested examples of the types of meetings that should be requested for topics related to chemistry, manufacturing, and controls (CMC) changes.

Question limit

AbbVie questioned FDA’s approach of limiting sponsors to no more than 10 questions in the meeting request package. The company asked for a rationale for the approach and whether there are circumstances in which more questions would be acceptable to the agency. AbbVie also noted that FDA does not specify how much time sponsors will have for milestone meetings. “We strongly recommend the option to extend meeting times for milestone meetings. We recommend FDA provide the appropriate meeting time to allow discussion of the questions that need to be answered to advance a development program,” AbbVie wrote.

Transparency

While members of industry commented on the details of the meeting guidance, five nonprofit patient research and advocacy groups called for greater transparency around meetings between FDA and industry in general. The groups included the National Center for Health Research, MedShadow Foundation, Patient Safety Action Network, USA Patient Network, and Washington Advocates for Patient Safety. The organizations cited the lack of information on the FDA website about which meetings are occurring and the lack of public access to meeting minutes.

“While we understand the need to protect propriety information, the need for transparency to regain the trust of the public is equally important. These issues of trust, expressed by Congress, researchers, the media, patients, and consumers, have arisen numerous times when the FDA has rejected an application and then later reversed itself with no public explanation or with inadequate transparency,” the groups wrote.

The groups said the public should be privy to when FDA rejects a sponsor’s package and if the sponsor challenges that decision or submits follow-up information.

Comments on formal meeting guidance

Drugmakers seek details on INTERACT meetings

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