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TMAP: Planning for Efficient, Effective Data Management at FDA

February 21, 2020

On an Alliance-sponsored webinar this week, FDA’s Principal Deputy Commissioner and Acting Chief Information officer, Dr. Amy Abernethy, spoke about the Technology Modernization Action Plan (TMAP) released by FDA and the next steps at the agency. … READ MORE …

Advocacy at a Glance

February 21, 2020

Alliance FY 21 “Ask” Set at $120 million above the FY 20 BA Appropriation. The Alliance’s Board of Directors met this week and set the Alliance’s FY 21 budget authority (BA) funding “ask” at $120 million above the FY 20 level for such FDA programs. … READ MORE …

Join Us for Our Annual Hill Day on March 18!

February 20, 2020

Each year the Alliance for a Stronger FDA goes up to Capitol Hill to visit with congressional offices to discuss the importance of a fully-funded FDA. This event is open to all participants, and you do not need to be an Alliance member to participate. To RSVP, please click here and our staff will send you information. … READ MORE …

Alliance for a Stronger FDA Announces New Officers for 2020

February 20, 2020

The Alliance has announced its complete set of officers for 2020. For full details please see the media release issued today.

The Alliance’s Assessment of the President’s FY 21 Budget Request

February 14, 2020

Q: What was the Alliance’s reaction to the President’s budget request?

A: The statement we released reads as follows:

In relative terms, we are pleased that the Administration’s commitment to FDA remains strong, even while many other worthwhile agencies are proposed for cuts. In absolute terms, further increases are going to be needed for FDA because the mission and responsibilities of FDA are still growing and the science is becoming more complex.

Q: What is FDA’s current and the President’s proposed funding levels? 

A: In FY 20, FDA received a budget authority (BA) appropriation of $3.159 billion for “salaries and expenses”.  The President is proposing a $47 million increase (about 1.5%) for FY 21, which would bring the agency BA funding level to $3.206 billion.

The Alliance has always used the salaries and expenses (S&E) number in describing FDA funding levels, because S&E is the most accurate reflection of FDA’s programmatic activity that is paid from the BA appropriation. In comparison to our numbers, the Administration’s summary document variously uses numbers that show an increase of between $23 million and $25 million. This reflects their decision to net out a $5 million decrease in Cures funding and an $18 million decrease in Building and Facilities (B&F) that was boosted in FY 20 by monies largely intended to be one-time investments. Note that Cures funding comes from reductions in mandated spending and is not BA (taxpayer) funding and Building and Facilities is carried as a separate account from S&E monies.

The President’s proposal for FDA for current law user fees for FY 21 is $1.96 billion, excluding tobacco user fees. The proposed $78 million increase in existing user fee programs is based on the formulas in the current user fee agreements. Therefore, the proposed funding does not represent any increase or decrease in Administration support.

Q: What is the Alliance’s most important message?

A: “Growing responsibilities require a budget that grows.” For this reason, our advocacy will emphasize ways in which the agency’s responsibilities have grown (breadth) and ways in which the job has become more complex (depth). To respond to these challenges, the agency needs additional budget, more scientific and technical staff, and better analytic tools (such as interoperable data systems) that support scientifically based decision-making. Examples of new technologies for which the agency needs additional capability and personnel: gene and cell therapy, digital health, artificial intelligence, cybersecurity of medical devices, and real world evidence. On the food side, there is whole genome sequencing, culture-independent diagnostic testing, and block chain.

Q: Is the President’s budget request “dead on arrival?”

A: No. Ignore anyone who says: “Don’t pay attention because the President’s budget is dead on arrival.”  In reality: whether Congress accepts or rejects the President’s proposals or adds more money, his numbers will be used as a baseline when the subcommittees mark-up. That matters.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA. We apologize once again for the 1 week delay in posting this information to this web site..

Advocacy at a Glance

February 14, 2020

Topline: The President’s budget request for FDA was released this week, with the President proposing a $47 million increase for the agency. This is described further in this week’s Advocacy at a Glance section (below) and in FAQs in this week’s Analysis and Commentary.

We apologize for the 1 week delay in posting the information below to this web site.

President Proposes Small FY 21 Increase for FDA.  In FY 20, FDA received a budget authority (BA) appropriation for salaries and expenses of $3.159 billion. The President is proposing a $47 million increase (about 1.5%) for FY 21, which would bring the agency funding level to $3.206 billion. This is reflected in the Alliance’s more detailed chart. The Alliance’s position is described in this week’s Analysis and Commentary. The President’s proposal is summarized here. The 400+ page Congressional Justification (CJ) is here.

Proposed Program Increases and Decreases in the President’s FY 21 Budget Request for FDA.  On pages 10-17 of the CJ for FDA, there is information on the Administration’s proposed programmatic increases and decreases in the agency’s funding. Specifically:

  • Artificial Intelligence and Other Emerging Technologies (Food Safety and Medical Products) (+$10.2M)
  • Strengthening Response Capabilities for Foodborne Outbreaks: (+$1.2 million)
  • Cannabis and Cannabis Derivatives (+$5.0 million)
  • Modernizing Influenza Vaccines (+$5.0 million)
  • Transform Medical Device Safety, Cybersecurity, Review, and Innovation (+$18.0 million)
  • Compounding (+$4.5 million)
  • Reductions to Outreach, Training, and Organizational Excellence (-$19.6M)

FDA Budget Request in Context. Given the overall budget situation for the non-defense discretionary (NDD) portion of the federal budget, even  the small increase proposed for FDA reflects strong Administration support for the agency. Apart from VA, NASA, and Homeland Security, the President’s budget request proposes deep cuts in NDD programs and FDA was one of the few that saw even a small increase. In the larger picture, the President’s proposed NDD spending is $15 billion below the actual FY 20 spend. With specific regard to Ag/FDA appropriations, the President’s request would cut 8% from current FY 20 funding.

Upcoming Alliance Events:

  • MARCH 18: For All FDA Stakeholders. March 18 (Wednesday) is the Alliance’s Hill Day. Please mark your calendars. We will be setting up dozens of Hill meetings, so we can use participants all day, or just in the morning or the afternoon. You do not have to be an Alliance member to be part of our Hill Day.
  • APRIL 1: For Food Safety Stakeholders. April 1 meeting at FDA with Frank Yiannis, Deputy Commissioner for Food Policy and Response. This will be an Alliance members-only meeting. This is the third of our FDA meetings this year.

Please let Reed know if you would like to participate in either of these events.

March 13 Deadline for Member Requests to House Appropriations Agriculture/FDA Subcommittee. Members of Congress can provide the House Appropriations Agriculture/FDA Subcommittee with a request for funding of programs of particular interest to them or their state or district. The Subcommittee has asked House Members to submit these requests by March 13. Every House office will have its own deadline in advance of this, as they consider what requests to submit. It is vital to the FDA cause that the Appropriations Subcommittee receive multiple requests for increased FDA funding. While the Senate Subcommittee has not yet set its deadline, individual Senators are already setting their deadlines and should be contacted as well. If your organization would like to ask Members’ office to support FDA, please contact Roger. He can supply the deadlines of specific offices, as well as suggest appropriate language to support your request.

Can We Help With Your Hill Day? Many of our Alliance members hold their own Hill days and we encourage you to include FDA’s increased funding needs among your “asks.” If you plan to do so, let us know the date and your needs (a one-pager, a paragraph, a chart, etc.) and we will be happy to support your efforts with regard to FDA funding. To follow-up on this, please contact Liz.

Alliance Issues Analysis of President’s FY 21 Request for FDA Funding

February 11, 2020

The Alliance for a Stronger FDA issued its analysis of the President’s FY 21 request for FDA funding on Monday this week; for details, please click here. … READ MORE …