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Advocating for a Responsibility-based “Ask”

April 3, 2020

The Alliance’s FY 21 “ask” (here) is based on two themes: growing FDA responsibilities require an FDA budget that grows; and FDA’s vital responsibilities have become more sophisticated and complex, requiring additional resources. … READ MORE …

Advocacy at a Glance

April 3, 2020

Top Line: The Alliance has a new date for our meeting with Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response and has submitted Congressional testimony on FDA’s FY 21 funding needs. This week’s Analysis and Commentary explores how that testimony changed to reflect FDA’s role in responding to the current and future crises. Finally, we look at the Congressional calendar and how FY 21 appropriations might be addressed (below). … READ MORE …

Coronavirus, Pandemic Preparedness, and Beyond

March 27, 2020

One of the surprises of the Alliance’s Hill Day on March 18 was that Hill staff were so willing to focus on topics other than coronavirus. … READ MORE …

Advocacy at a Glance

March 27, 2020

TOPLINE: FDA would receive another $80 million in no-year money under the third pandemic response legislation. Congress might find it necessary to run a virtual appropriations process. In this week’s Analysis and Commentary, there is a continued discussion of Hill Day and a new discussion on why FDA’s mission cannot be ignored while our attention is focused on the pandemic.

FDA Gains $80 Million in Third Pandemic Relief Bill. The $2 trillion legislation (Senate passed, pending House action) would provide $80 million in no-year monies (i.e., available until expended)

to prevent, prepare for, and respond to coronavirus, domestically or internationally, including funds for the development of necessary medical countermeasures and vaccines, advanced manufacturing for medical products, the monitoring of medical product supply chains, and related administrative activities.

This is the same language that accompanied $61 million that was provided to FDA under the first pandemic response legislation (described here and here). The use of identical language suggests that FDA and HHS are satisfied that they have the authority to use these monies to fight the pandemic by whatever means are appropriate. While adding $141 million in no-year money to FDA’s budget reflects the cost and urgency of fighting the coronavirus, this week’s Analysis and Commentary examines the agency’s other continuing resource needs.

Advanced Manufacturing Has Large Role in Pandemic Response Legislation. The language that directed $61 million and now $80 million to FDA makes specific reference to “advanced manufacturing for medical products” as a purpose for which the monies can be spent. The rationale is that such efforts enhance opportunities for medical product manufacturers to re-locate production to the US, resulting in lower costs and shortened supply chains. This concept appears elsewhere as one of the many uses for which monies can be used under the Public Health and Social Services Emergency Fund. Additionally, $10 million is provided for “development and manufacture of new medical countermeasures and biomedical supplies to combat the coronavirus” at the National Institute for Innovation in Manufacturing Biopharmaceuticals, which is a Commerce Department program.

Alliance to Meet (Virtually) with FDA Food Safety Leader, Frank Yiannas. On April 1, the Alliance will hold a teleconference meeting with Frank Yiannas, MPH, Deputy Commissioner for Food Policy and Response. The meeting, which runs from 1:00 to 2:00 p.m., will provide the opportunity for him to discuss budgetary and resource needs for FDA’s food safety programs. This meeting is open to Alliance members and media. Please e-mail Reed to attend. If you would like to participate, but are not yet an Alliance member, please contact Steven.

Congressional Calendar. Congress is almost entirely focused on two challenges: (1) what can they do to slow the pandemic and save the economy, and (2) how can an organization that is premised on the interactions of 535 people (and staff) function in a time when social distancing is mandated and most Members of Congress want to be home and not in DC. Accordingly, the Senate is targeting April 21 as the next day on which Senate business will be conducted, subject to be called back for an emergency. Once the House finishes with the third coronavirus legislation, we expect them to adopt a similar schedule. (Note: We have been told that more than a third of Congress would qualify as high-risk based on age and other factors.)

Possible Need for a Virtual Appropriations Process. For several weeks, we have been suggesting that the “must-be-completed” FY 21 appropriations process may need to be recreated in “virtual” form. It is difficult to imagine running hearings, mark-ups, and even having extended floor debate with a 6-foot distance between participants. And that is not to mention that most Members appear to want to be home in their districts rather than in DC. Senate Appropriations Committee Chairman Richard Shelby suggested that further hearings with Administration witnesses might be cancelled or done virtually, but held out hope that face-to-face meetings might be possible before mark-ups begin in May and June (Roll Call story here).

Alliance for a Stronger FDA — FY 21 “Ask” and Explanation

March 20, 2020

“Growing Responsibilities Require a Budget that Grows”

The FDA’s mission continues to grow; vital responsibilities have become more sophisticated and complex. Accordingly, the Alliance’s FDA “ask” for FY 21 is for an increase of $120 million in budget authority (BA) above the FY 20 appropriations level. This would bring FDA “salary and expenses” to $3.278 billion. This would be an overall increase of just under 4% compared to the FY 20 enacted levels and an increase of $72 million over the Administration FY 21 request. Funding under 21st Century Cures, $70 million, is additional.

The agency needs an increased budget, more scientific and technical staff, and better analytical tools to support scientific-based decision-making and innovation in both food safety and medical products activities.

  • In food safety, this means use of artificial intelligence, whole genome sequencing, culture-independent diagnostic testing, and enhanced electronic record-keeping.
  • In medical products, this means new tools to evaluate medical products that incorporate cell and gene therapy, digital health, artificial intelligence, and real-world evidence and other new technologies.

Food Safety — In FY 20, Congress committed more than $1.4 billion in BA funding to food safety, nutrition, cosmetics, dietary supplements, animal foods, and other food elements of FDA’s mission.  For FY 21 for food safety programs, the Alliance is recommending a $50 million increase in BA program funding (or $41.6 million more than the President’s request for food safety programs).

We urge Congress to consider:

  • More robust and rapid FSMA implementation, including increased cooperation with states, finalization of guidances including traceability, and a focus on produce safety, import safety, and training/education;
  • Enhanced funding of systems for surveillance of foodborne illness and outbreak response;
  • Upgrades to the public health laboratories network;
  • Strengthening the scientific capabilities of CFSAN, CVM, and NCTR.

Funding should also be considered for: FDA’s recall initiative, nutrition education, safety of cosmetics and dietary supplements, antimicrobial resistance, CBD, and standards of identity/food labeling and product claims.

Medical Products — In FY 20, Congress committed nearly $1.7 billion in BA funding to support drug, devices, biologics, and other medical product elements of FDA’s mission. For FY 21 for medical products, the Alliance is recommending a $70 million increase in BA program funding ($39.9 million more than the President’s request for medical products programs).

We urge Congress to consider:

  • Addressing the shortage of agency staff and expertise in (1) new high-growth scientific areas, notably the dramatic increase in products being developed with gene and cell therapy and (2) new technology-driven challenges, such as cybersecurity, artificial intelligence, digital health, and blockchain;
  • Expanding the FDA’s ability to respond to public health emergencies, including coordinated efforts to speed development of diagnostics, therapeutics, and vaccines for viral and other emerging threats to public health;
  • Strengthening FDA ability to address the safety of imported medical products and APIs;
  • Renewing and expanding initiatives first funded in FY 19, including innovative initiatives in advanced manufacturing, outsourcing, real world evidence, compounding, generics and rare diseases.
  • Strengthening the scientific capabilities of CDER, CBER, CDRH, CVM, and NCF.

Funding should also be considered for: integrated knowledge management systems to support medical device and biologics; and efforts to develop and integrate interoperable data systems.

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

March 20, 2020

Topline: The Alliance successfully completed its first virtual Hill Day. This year, Hill staff were more aware of FDA’s importance, largely because of its role in combating the pandemic. The Alliance has an upcoming meeting with FDA’s Frank Yiannas. Testimony to appropriations committees is due soon.

Alliance Completes Hill Day with Conference Calls and Much Enthusiasm on Both Sides. For Alliance members and Hill staff alike, it was a new experience — Hill Day by phone. It worked remarkably well. More than 40 Alliance members were organized into seven teams (5 House, 2 Senate) and completed more than 50 meetings. Most of our meetings with Ag/FDA subcommittee members were completed in February, so Hill Day concentrated on remaining appropriations subcommittee and committee members plus a broad sampling from the authorizing committees. A large number of the Congressional staff were working from home, as were most of our Alliance members. Everybody appreciated the opportunity to exchange information, while practicing social distancing.

This year’s Hill Day was notable because FDA was already on the minds of Hill staff. They understood that NIH, CDC, and other government agencies have important roles to play. We didn’t need to tell them that COVID-19 diagnostics, therapeutics, and vaccines are reviewed by FDA and that it is important to know more than safety and efficacy. Or as Commissioner Hahn has observed: the FDA has to assure that the “right drug” goes to the “right patient” at the “right dosage” and at the “right time.” Next week’s Friday Update will give a fuller description of Hill Day.

Alliance to Meet (Virtually) with FDA Food Safety Leader, Frank Yiannas. On April 1, the Alliance will be holding a teleconference meeting with Frank Yiannas, MPH, Deputy Commissioner for Food Policy and Response. The meeting, which runs from 1:00 to 2:00 p.m., will provide the opportunity for him to discuss budgetary and resource needs for FDA’s food safety programs. This meeting is open to Alliance members and media. Please e-mail Reed to attend. If you would like to participate, but are not yet an Alliance member, please contact Steven.

Upcoming Deadlines for Congressional Testimony. The House Ag/FDA Appropriations Subcommittee will accept public testimony until COB on Tuesday, March 31. Details on submitting testimony are here. The Senate Ag/FDA Appropriations Subcommittee will accept public testimony until COB on Monday, April 6. Details on submitting testimony are here. In both House and Senate, subcommittee members and staff notice how many organizations choose to testify on specific funding requests, so please make a difference for FDA by testifying.

Alliance members interested in submitting testimony should contact Roger or Liz. We can provide advice on the process and help with Alliance materials that will support your efforts. The key document is the Alliance’s FY 21 “ask,” which is contained in this week’s Analysis and Commentary and is also available online here.

Congress Focused on Coronavirus Response; FY 21 Appropriations Plans Unclear. Based on discussions with staff this week, the presumption is that the Appropriations Committees will start the FY 21 funding process after they complete action on the FY 20 supplemental funding to combat the coronavirus pandemic and support the economy. The reality is harder to predict. Previously, the House announced subcommittee and full committee mark-ups in late April and May, although those are no longer on the calendar. The goal was to complete House floor action on all appropriations bills by the end of June. We have expected the Senate to trail, with subcommittee and full committee mark-ups in May and June, with the first appropriations bills reaching the Senate floor near the end of June and into July. The Senate never announced any dates (other than public testimony), so at this point there is nothing for them to revise or withdraw.

Congress is certainly committed to passing FY 21 appropriations bills, but faces a strong headwind with the pandemic, the economy, a Presidential election year, and partisan disputes that are unresolved (e.g., border wall funding). It is a strong possibility that there will be a Continuing Resolution from October 1 to about November 20, 2020. In the interim, it remains to be seen whether there can be a virtual appropriations process if the appropriations committees can’t have hearings, mark-ups, and extended floor time because of the pandemic.

“Cures,” Coronavirus, NDD, and Other Issues for FY 21

March 13, 2020

Q: The Alliance is asking for $3.278 billion for discretionary funding for the FDA, plus $70 million in 21st Century Cures funding. … READ MORE …