Sponsor-FDA Communications In IND Phase Will Get Outside Review

US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.

The US FDA is ready to assess and potentially improve its drug development communication practices after similar efforts related to the application review process, another addition to a growing list of efforts to improve transparency.

The agency wants to hire Eastern Research Group (ERG), which has conducted several similar studies of FDA practices, to look at IND-phase communications. The agency said in a Federal Register notice expected to be published Aug. 16 that it has asked for permission from the Office of Management and Budget to conduct the assessment.

FDA is seeking IND sponsor perspectives on "what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement," according to the notice.

ERG would conduct surveys and interviews with 100 to 150 active commercial IND holders. Surveys would be sent to IND sponsors following formal meetings to gain feedback on the communications practices used for the meeting. Sponsors conducting Type A, B, B (end of phase) and C meetings would be included in the cohort, according to the notice.

It appears the surveys will cover situations where the agency is addressing problems as well as milestones and other drug development issues.

Type A meetings generally are reserved for stalled development programs or to address important safety issues, including dispute resolutions and clinical holds. Type B meetings can include discussions following an agency action other than an approval, and Type B (end of phase meetings) include discussions at the end of phase I or II or before phase III. Type C meetings can include early discussions of the use of a biomarker as a new surrogate endpoint and other topics not covered by Type A and B meetings.

Researchers also would interview one to three representatives of each sponsor in the assessment to learn more about communication outside the meetings, including email and telephone interactions. FDA expects sponsors will need 10 minutes to complete a survey. Including scheduling and participation time, interviews were estimated to take 90 minutes, according to the notice.

 

The resulting report, due in April 2020, would include recommendations for improvement based on the sponsor information and feedback from FDA review staff.

The sample cohort will be small – it will cover 2.5% to 3.75% of the 4,000 INDs that have activity each year.

Part Of PDUFA VI Commitments

FDA committed to the survey as part of the 2017 prescription drug user fee reauthorization. Findings could inform updates to guidance on best practices for communication between IND sponsors and FDA based on the results, although that document was finalized in late December 2017. The agency also will convene a public workshop by the end of March 2021 to discuss the results.

FDA also agreed in PDUFA VI to maintain a dedicated communication and training staff in the centers for drug and biologics evaluation and research. They will help facilitate sponsor-FDA interactions during drug development, as well as serve as a contact point when a sponsor has a general question about drug development or needs help finding the proper review division to send questions. Liaisons also will help sponsors when they do not receive responses to questions.

In addition, reviewers will be trained on best practices and the role of the liaison staff, according to the PDUFA VI commitment letter.

Enhanced communications are part of agency efforts over the years to become more transparent about its decision-making and operations, in part to improve consistency and predictability, although that has brought drawbacks along with benefits. (Also see "Decline In Civil Discourse Harms US FDA's Operations, Woodcock Says" - Pink Sheet, 29 Jun, 2018.)

ERG Worked On PDUFA V 'Program,' Benefit-Risk Framework

Eastern Research Group has an extensive history with FDA related to PDUFA-related assessments.

The company conducted the interim and final assessments of the changes to the NDA/BLA review system that were implemented in PDUFA V. FDA and industry agreed the review time would be lengthened two months and mid- and late-review cycle communications would be incorporated.

ERG recommended FDA improve transparency with its inspection system when research found that sponsors could not determine how to find inspection information at the agency. (Also see "PDUFA V ‘Program’ Gets Positive Evaluation – Except For Inspections" - Pink Sheet, 1 Apr, 2015.) It's interim assessment also revealed trepidation among some at FDA about the increased workload the additional communication created. (Also see "PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA" - Pink Sheet, 6 Apr, 2015.)

The company ultimately determined that the "Program," as the new review model was termed, allowed for more first-cycle approvals. (Also see "PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications" - Pink Sheet, 12 Dec, 2016.)

ERG also assessed FDA's implementation of the benefit-risk framework, intended to allow reviewers to detail how they reached a decision on an application. (Also see "US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved" - Pink Sheet, 20 Sep, 2017.) Among the recommendations was to make the completed frameworks more accessible, which could include using them in the advisory committee process. (Also see "Benefit-Risk Frameworks May Be Coming To US FDA Advisory Committees" - Pink Sheet, 3 Apr, 2018.)