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Public Trust in the US FDA

September 18, 2020

FDA’s reputation has been very much in the news lately. Obviously, this will inform the appropriations process and may well have consequences. Therefore, we at the Alliance will continue to monitor this situation and consider how appropriations are affected. … READ MORE …

Advocacy at a Glance

September 18, 2020

Top-Line: A Continuing Resolution is on track for a House vote next week and must then pass the Senate before October 1. Growing interest in advanced manufacturing is discussed. Acting CDER Director Patrizia Cavazzoni, MD, and Director of the Office of New Drugs Peter Stein, MD, will present to the Alliance on October 16. This week’s Analysis and Commentary examines polling data that may have consequences for FDA in the FY 22 funding process that will start early next year. … READ MORE …

Following the Science to Protect Public Health

September 11, 2020

From USA Today, 9/10/20:

Patrizia Cavazzoni, Peter Marks, Susan Mayne, Judy McMeekin, Jeff Shuren, Steven Solomon, Janet Woodcock, and Mitch Zeller

Opinion Contributors

A lot has been said and written recently about the Food and Drug Administration. The integrity and independence of the agency have been called into question. … READ MORE …

Advocacy at a Glance

September 11, 2020

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. … READ MORE

Understanding Tom Frieden’s Proposed HDO

September 4, 2020

In a May column (here), I talked about a proposal to create a Health Defense Operations (HDO) fund. The gist of the article was that such a fund might provide a way to break an impasse over the budget cap for Non-Defense Discretionary (NDD) for FY 21.

Advocacy at a Glance

September 4, 2020

Top-Line: Acting CDER Director Patrizia Cavazzoni, MD, and Director of the Office of New Drugs Peter Stein, MD, have accepted our invitation to speak at a special Alliance webinar, scheduled for September 28. A Continuing Resolution (CR) to continue government funding after October 1 is inevitable. The important details are still missing: when will it pass, how long will it run, and what other legislation will be tucked into it. This week’s Analysis and Commentary explores the concept of a Health Defense Operations (HDO) fund and its possible implications for FDA. … READ MORE …

“Somehow the CR Will Pass”, But When?

August 14, 2020

In most years, the appropriations committees try to move funding bills forward, even knowing that on-time completion (before October 1) is very unlikely. … READ MORE …

Advocacy at a Glance

August 14, 2020

Top-Line: The House will not return to DC until September 8 (for committee work) and until September 14 for floor votes. While the Senate is scheduled to return on September 8, as well, no specific floor or committee schedules have yet been announced. It is all but certain that FDA and the rest of the government will be funded under a Continuing Resolution. Party Platforms are reviewed, although they are probably not important. This week’s Analysis and Commentary describes the policy and political environment for FY 21 funding between now and the end of the calendar year. … READ MORE …