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Why No Movement in the Senate?

July 18, 2020

Q: If the bills are drafted, what is stopping the Senate from moving forward?

A: Several times this year I have written about the “hurry up, then slow down” pacing of the appropriations process over the last decade. No one becomes an appropriator unless they believe that completion of the process each year is important. Leadership has a similar interest: completed funding bills are widely interpreted as a sign of a productive Congress.

All that forward motion eventually comes up against the nearly immovable resistance caused by Congressional gridlock. Appropriations bills can’t move in the Senate right now because, among other things, Senator Shelby is arguing that Democrats are breaking an agreement that only mutually agreed-upon amendments would be considered. Senator Leahy says that the agreement only covered the prior year when it was negotiated. It sounds like a petty “he said, she said” spat.

In fact, the current deadlock does not rest on trivial issues or stubborn personalities. If Senator Shelby schedules a mark-up, his colleagues — five of whom are up for re-election — will face a succession of Democratic amendments designed to put them on the record in a way that could hurt their campaigns.

Q: Could the Senate deadlock break and what happens if it doesn’t?

A: Nothing prevents a Shelby/Leahy agreement. It might take the form of something like: Democrats can offer these three amendments, but can’t offer these other seven. If that occurs at all, it seems more likely to be in September than now. First, emergency supplementals are appropriations bills, so appropriators will have their hands full over the next 3 weeks. Even if there was time, attention span and good will sufficient to release bills and hold mark-ups, it is hard to see the benefit to election-year Republicans of giving an extra month of exposure to their positions.

Actually, the situation is even a bit worse than that for those (like us) who favor completion of the appropriations process before October 1. Senate floor votes on appropriations are not likely to happen before November. Otherwise, the 20 incumbent Republican Senators running for re-election would face difficult votes on Democratic amendments. Even after the election, the Senate is likely to conference their committee-passed bills with the House-passed bills. This is not uncommon but bound to have difficulties, particularly were to occur ahead of the election.

The most likely — but not certain — scenario is: (1) the emergency supplemental bill occupies the next 3 weeks, (2) Senate Republicans move slowly, if at all, in September and pass a CR early (maybe September 18 to send their troops home to campaign), and (3) the CR would run until after the election. Whether there will be agreements on funding in November/December or another CR into 2021 will depend on what happens in the election.

As a general matter, the flat funding that comes with a continuing resolution is particularly bad for agencies, such as FDA, whose missions and responsibilities are growing. Their ability to increase their efforts is likely to be thwarted as long as the CR is in place.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.

Advocacy at a Glance

July 18, 2020

Top-Line: The House is likely to vote on FY 21 Ag/FDA appropriations next week. Committee action in the Senate on FY 21 appropriations is stalled by a number of factors and is unlikely to come up before September at the earliest. FDA has resumed domestic inspections and launched its New Era of Smart Food Safety initiative. A hearing is slated on FDA’s Hiring and Retention Policies. This week’s Analysis and Commentary explains Senate (in)action and the most likely scenarios for FY 21 funding. … READ MORE …

CBER Director on COVID-19 and Vaccine Development

July 10, 2020

On July 8, the Alliance for a Stronger FDA was pleased to host a webinar with Peter Marks, MD, PhD, Director of FDA’s Center for Biologics Evaluation and Research. He joined the FDA in 2012 as CBER’s Deputy Director before becoming Director in 2016. … READ MORE …

Advocacy at a Glance

July 10, 2020

Top-Line: The House Appropriations Committee approved an FY 21 Ag/FDA funding bill with an increase of $41 million for FDA. CBER Director Dr. Peter Marks addressed Alliance members and the media on July 8 on vaccine development. There were nearly 100 participants and his remarks were widely covered by the media. This week’s Analysis and Commentary summarizes his remarks. The next Alliance webinar — with former FDA Chiefs of Staff — is on July 23. … READ MORE …

FDA Is Its People … and They Need Our Support (Redux)

June 26, 2020

Steven is away this week and suggested we reprint an edited version of one of his earlier columns on the FDA budget. … READ MORE …

Advocacy at a Glance

June 26, 2020

Top-Line: CBER Director Peter Marks, MD will address the Alliance on July 8. The Friday Update will not be published on July 3 in observance of Independence Day. The House plans to markup all of their appropriations bills beginning on July 6, while appropriations bills remain stalled in the Senate. FDA announced it will roll out the blueprint for the New Era of Smarter Food Safety in the coming weeks. This week’s Analysis and Commentary discusses some of FDA’s responsibilities and the budget it requires to perform its critical public health mission. … READ MORE …

How Well Is This Year’s Appropriation Process Working?

June 19, 2020

Q: Will the current set of House and Senate mark-ups be completed before August, setting up September enactment of FY 21 funding bills? … READ MORE …

Advocacy at a Glance

June 19, 2020

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. … READ MORE …