Upcoming Webinar with CBER Director Peter Marks, MD

Top-Line: CBER Director Peter Marks, MD will be addressing the Alliance on July 8. The House and Senate still plan appropriations mark-ups, but the Senate faces new delays and the House won’t be starting until after the July 4th recess. FDA continues to publish guidance to aid sponsors whose clinical trials are at risk because of the pandemic. This week’s Analysis and Commentary returns to the Q&A format and addresses FDA’s situation within the current appropriations process.Upcoming Webinar with CBER Director Peter Marks, MD. We are honored that Dr. Marks has accepted our invitation to speak on a special Alliance webinar, scheduled for 2:00 p.m. on July 8. To sign-up to participate, please contact Reed. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven.House Still on Target to Move FY 21 Funding Bills Starting July 6. The House Appropriations Subcommittees are expected to markup all 12 bills upon their return from Fourth of July recess. The Agriculture/FDA bill is set for Subcommittee mark-up at 6:00 p.m. on July 6. The bill is scheduled for consideration by the full Committee on July 9. House action on all 12 bills is slated for the weeks of July 20 and 27, although no dates have been set yet. There is an expectation that multiple bills will be packaged together into “minibus” bills. It has not yet been announced which bills will be combined into each minibus.Senate Effort to Move FY 21 Funding Bills Before Recess Stalls. The Senate Appropriations Committee had planned to start mark-ups this month. They had scheduled seven bills for the next 2 weeks and then would finish the remaining five after the Fourth of July recess. Various alternative schedules have been floated, containing different orders for the bills to come up and different dates on which they would be considered, both before and after recess.All of these plans came crashing down when Senate Appropriations Chair Shelby complained that Ranking Member Leahy and other Democrats were trying to include provisions related to policing and to add some coronavirus funding. Senator Shelby suggested that the policing provisions were authorizing matters, not appropriations, and that there was an agreement that additional coronavirus funding would be considered in the FY 20 Supplemental bills rather than FY 21 appropriations bills. Understandably, Senator Leahy does not agree and no mark-ups are scheduled at this point and are unlikely until this dispute is resolved.FDA Adds to Its Guidance on Continuation of Clinical Trials Impacted by COVID-19. While combating COVID-19 is our national priority, it is imperative that we not lose knowledge being gained through clinical trials in other disease areas. The FDA has now released guidance (here) that

outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.

This complements advice already provided by FDA on continuation of clinical trials (here).