On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors. The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward. Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.
By filing an IND, a drug developer seeks approval to conduct human trials of investigational new drugs. After an organization submits an IND application to the FDA for approval, the FDA review team must review the submission within a 30 day period and determine whether to approve or deny the application. During this period, the FDA review staff and IND sponsors communicate regarding IND status, concerns, and questions, and the clock stops on the 30-day period any time the FDA requests additional information from the sponsor. Overall, this process is designed to minimize the risk of harm to clinical trial volunteers and confirm that the clinical trial protocols are appropriate. Further, the FDA reviews the proposed study protocol to confirm sponsors’ plans support compliance with good clinical practice requirements. The FDA released guidance last December on best practices for communication between IND sponsors and FDA review staff in order to assist in improving the effectiveness, timeliness, and transparency in communications between the parties. Additionally, the FDA believes that improved communication may assist in facilitating the availability of effective and safe drugs to consumers.
The FDA expects that the upcoming review, pending OMB approval, will shed more light on how commercial IND sponsors perceive their communications with FDA staff. During this review, ERG will collect data from sponsors of “a sample of up to 150 active commercial INDs that have activity during a one-year period.” The surveys (which can be found here) and interviews with IND sponsors are intended to assess sponsors’ experiences when communicating with the FDA review staff, and will examine “what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement.” After this data is analyzed and reported by ERG, the FDA will “publish the report on the Agency’s public website and hold a public meeting about the assessment.”
The study findings may be useful in assisting the FDA in meeting its PDUFA commitment to promote transparency between sponsors and review personnel. The PDUFA plan emphasizes its goal to promote effectiveness and efficiency of the first cycle review process while minimizing the number of review cycles necessary for approval. Sponsor recommendations through the surveys may very well shed light on current communication issues as well as other factors that might hinder the approval process. An understanding of such hindrances may assist FDA in improving communication and transparency between parties and, thus, the IND approval process itself.
EBG will continue to monitor all developments in FDA’s regulation of the IND approval process as well as the forthcoming results from ERG’s review of IND sponsor communication with FDA review staff.