Alliance Webinar with CDER Postponed, Will Be Rescheduled Shortly

Top-Line: The House and Senate will be focused on the FY 21 Continuing Resolution over the next two weeks to assure there is no government shutdown on October 1. The Alliance’s webinar with CDER directors will be rescheduled from its previous date. The new time will be widely circulated. The Alliance for Aging Research is circulating a sign-on letter about the role of science in policy-making. This week’s Analysis and Commentary reprints an op-ed, published this week, that provides the view of FDA’s senior career leadership on the priority they give to science-based decision-making.Alliance Webinar with CDER Postponed, Will Be Rescheduled Shortly. We are pleased with the outstanding response to last week’s announcement of an Alliance webinar with Acting CDER Director Dr. Patrizia Cavazzoni and Office of New Drugs Director Dr. Peter Stein. The date announced (September 28) is no longer viable, but we should have a new date shortly. If you have already signed up, you will get a note directly asking if you still will be able to attend. For all others, we expect to have a date to announce in next week’s Friday Update and will also circulate a new invitation to our mailing list. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.CR Funding Will Be Needed to Begin FY 21. With this week’s failure of the Senate Republican’s “skinny” COVID-19 supplemental legislation (passed, but didn’t reach 60 votes necessary for cloture), it seems that Congressional leadership is finally admitting out loud that the continuing resolution (CR) is the only vehicle certain for passage in September. Yet to be resolved are: if any other legislation might be added onto the bill given that Speaker Pelosi and Senate Appropriations Chairman Shelby suggest the CR will be “clean”; anomalies; and the date to which the CR would extend.The other legislation category is open-ended at this point, but is usually limited to things like one-year extensions of certain expiring programs. Anomalies are OMB-Congress’ agreement on fixing situations where there would be an unacceptable result created by the impact of the CR. An example might be a loan fund program that, by law, would otherwise cease to exist if not provided for in some way under a CR. The date to which the CR is extended is likely to be a debate between the end of the second week of December versus February or March of next year. We think the December date is a tad more likely because--depending on the election and politics surrounding it--it leaves the flexibility to settle FY 21 funding in either timeframe.FDA and Politics: Controversy that FDA Wishes it Could Avoid. We feel certain that all Alliance members, indeed all our readers, are aware of the current back-and-forth in the media about FDA’s response to the COVID-19 pandemic. In the September 10 (yesterday) USA Today, the senior career executives at FDA -- who oversee all the work of the agency’s centers and field operations -- published an opinion editorial expressing their views on the situation and their commitment to science-based decision-making. Their views deserve a wide audience. To contribute to that, this week’s Analysis and Commentary reprints their op-ed. Our Deputy Executive Director, Steven Grossman, will be back next week with fresh insights for Analysis and Commentary. For this week, though, we urge you read what the Center directors have said.“Follow the Science” Sign-on Letter Being Circulated by Alliance for Aging Research. Long-time Alliance for a Stronger FDA member, Alliance for Aging Research, is spearheading a multi-stakeholder letter that asks our federal and health care agency leaders to let science, not politics, lead the way. A copy of the draft letter is here. Our Alliance members are urged to review the letter and consider signing on. The final letter, with a large number of co-signers, will be released ahead of the Senate HELP hearing, COVID-19: An Update on the Federal Response on September 23rd. To sign-on, please use this Google sign-on link by noon EDT on Wednesday, September 16th, or contact Michael Ward by e-mail.