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About the Alliance for a Stronger FDA

August 1, 2020

We are often asked about the Alliance, its origins and accomplishments. … READ MORE …

Advocacy at a Glance

August 1, 2020

Top-Line: The House should complete — by later today — action on 10 of the 12 appropriations bills, including Ag/FDA. The next step will be for the Senate to start moving their own bills, but it seems likely that we will have to wait until after Election Day for final action. A Continuing Resolution will be needed to fund the government starting October 1. This week’s Analysis and Commentary looks at the history of the Alliance and its accomplishments.

Reminder to Media: The Alliance’s Friday Updates (including the sections on Advocacy at a Glance and Analysis and Commentary) are on-the-record. Further, we are always available to both our members and media to answer additional questions.

House Will Pause Once It Has Completed 10 of 12 Appropriations Bills. The House finished its consideration of Ag/FDA appropriations on July 24 as part of H.R. 7608, a four-bill minibus that also includes State-Foreign Operations; Interior-Environment; and Military Construction and Veterans Affairs. The House started consideration this week of a six-bill minibus, H.R. 7617 and it should pass on July 31.  At that point, the House will have moved 10 of the 12 appropriations bills. They will be waiting for the Senate to release drafts and act upon their own version of the 10 bills. Senate action will not come until September at the earliest.

The House has not moved forward on the committee-passed Homeland Security and the Legislative Branch funding bills. Although no reason has been given publicly, it is possible that the Legislative Branch funding bill is being delayed so proponents and opponents of a Congressional pay raise can slug it out in the post-election session.  Likewise, while no reason has been given publicly, Homeland Security is likely being held up because of immigration and/or border wall funding issues. In both cases we are speculating, but if we are correct, the bills will not come up until after the election.

The Senate and FDA Appropriations: No Movement, No Surprise.  A number of disagreements — substantive, procedural, and political — have kept Senate Appropriations Committee Chairman Shelby and Ranking Member Leahy from releasing bills and scheduling mark-ups.

FY 21 Appropriation: Qs&As

July 26, 2020

Q: You have repeatedly referenced how tight the budget situation was this year (here). How did this play out for Ag/FDA funding?

A: The Ag/FDA subcommittee allotment reflected the overall tightness of the budget situation and provided little money for increases or new program initiatives. The subcommittee bill that became part of the H.R. 7608 minibus featured discretionary budget spending totaling $24.3 billion. The breakout of how that is to be spent is contained in this fact sheet and reflects the subcommittee’s concerns about immediate pandemic-related problems in the rural economy, feeding programs, and the food supply.

In a statement at the time of the committee mark-up, the Alliance thanked the committee

for its continuing support of the resources FDA needs to meet its expanding responsibilities. We view the proposed $41 million increase in FY 21 as a vote of confidence in the agency, given the severe budgetary constraints for all federal programs. We believe the FDA will still need more resources in the coming fiscal year to fulfill its mission and we will continue to work with Congress to achieve that end.

Q: What are the consequences for FDA if the agency begins the fiscal year (October 1) with funding from a Continuing Resolution?

A: The consequences of a CR are severe, even though they may be temporary. The FDA would need to carry out its programs using the FY 20 (prior year) funding levels, without the increased monies proposed for FY 21 by the House. Further, FDA would be limited in its ability to start new initiatives (variously defined) for as long as it is on CR funding. Last (but hardly least), CRs create uncertainty, which makes program and personnel planning difficult.

Q: What is the status of monies that FDA has been receiving under the 21st Century Cures Act?

A: The House bill, H.R. 7608, provides FDA with $70 million to fulfill medical product development goals set by the 21st Century Cures Act legislation. Because the monies are derived from savings in mandatory programs, these funds must be appropriated but do not count against any discretionary budget ceilings. To reflect this distinction, these funds are in a separate section that comes after the main FDA appropriation of taxpayer and user fee funds.

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 26, 2020

Reminder to Media: Friday Updates (comprising “Advocacy at a Glance” and “Analysis and Commentary”) is on-the-record. Further, we are always available to both our members and media to answer additional questions.

Top-Line: The House completed action on the FY 21 Ag/FDA appropriations bill, in which FDA would receive a $41 million increase. The next step would involve Senate mark-ups, which could be in September, but are more likely to be post-Election Day. This week’s Analysis and Commentary has another series of Q&As that clarify aspects of the current funding situation, overall and for FDA. … READ MORE …

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 …