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“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 …

CDER Priorities: During the Pandemic and for 2021

August 7, 2020

CDER Deputy Center Director for Operations Dr. Patrizia Cavazzoni met with the Alliance (by conference call) on August 4. … READ MORE …

Advocacy at a Glance

August 7, 2020

Top-Line: Given that it has been so hard to reach agreement on the COVID-19 supplemental appropriations bill, it is hard to imagine action on the FY 21 funding bills before October 1. There will need to be a Continuing Resolution, with FY 21 funding considered after Election Day. The Alliance met with senior CDER staff and the meeting is summarized in this week’s Analysis and Commentary. … READ MORE …

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. … READ MORE …

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 …