CR Likely for rest of FY22; User Fee Reauthorization More Hopeful
FY 23 Continuing Resolution Likely On House Floor the Week of September 12.
User Fee Legislation: Status Unchanged but Situation Becomes More Hopeful.
Can’t Get Enough News About FDA Activities?
White House Conference on Hunger, Nutrition, and Health to be Held September 28.
September Events in the Alliance’s Webinar Series:
September 16 at 11:00 a.m. “Celebrating 10 years of Patient-Focused Drug Development” with Dr. Theresa Mullin, CDER Associate Director for Strategic Initiatives;
September 27 at 11:30 a.m. “FDA and One Health” with Dr. Steven Solomon, Director of the Center for Veterinary Medicine, and Dr. Namandjé N. Bumpus, FDA’s new Chief Scientist.
This week’s Analysis and Commentary discusses the impact on FDA of funding by Continuing Resolution (CR). In particular, the column focuses on how much better FDA funding would be under either the House or Senate appropriations bills, rather than the CR.
FY 23 Continuing Resolution Likely On House Floor the Week of September 12. With the new fiscal year starting on October 1 and no final action on FY 23 appropriations bills, Congress will move forward to pass a CR. House action is scheduled for next week, with Senate action likely later in the month. A consensus is forming that the CR should continue until December 16.
Still evolving: what else might go into the CR in addition to funding for government programs. On the table possibilities: additional aid for Ukraine (likely), additional COVID-19 and monkeypox funding (unlikely), disaster relief (may be put into an emergency supplemental instead of the CR).
User Fee Legislation: Status Unchanged but Situation Becomes More Hopeful. After a quiet August, there is hope that the key legislative leaders are ready to schedule a negotiating meeting. This comes from a reliable source, but is, as of yet, unconfirmed. (per BioCentury article. log-in and choose free registration).
The article quotes heavily from last week’s Analysis and Commentary column (here). In that, Alliance Executive Director, Steven Grossman, discusses the impact of delay on FDA employees, the certainty of user fee renewal, and the need for the stakeholder community to be patient while Congress brings the situation to resolution.
Key quotes from the Analysis and Commentary:
“For existing FDA staff, the current period of uncertainty affects operational cohesion and morale. For individuals being recruited, some merely waiting for a signed employment letter, there is the threat of a permanent loss for the agency, as many may take their skills elsewhere.”
“There will be a user fee deal. Full Stop. Details may be undecided; consequences may be uncertain. But there will be a deal.”
Can’t Get Enough News About FDA Activities? Often, but not every day, FDA publishes an “FDA Round-up” column in the Press Announcements section of its website. Here is a sample from earlier this month (September 6, 2022).
White House Conference on Hunger, Nutrition, and Health to be Held September 28. In May, the President announced the White House Conference, the first one on this topic in 50 years. Useful information about the conference and the link to livestream the event are here.
The Administration has announced five pillars that will define its effort to reduce hunger and promote health:
Improve food access and affordability
Integrate nutrition and health
Empower all consumers to make and have access to healthy choices
Support physical activity for all
Enhance nutrition and food security research
September Events in the Alliance’s Webinar Series with FDA Leadership.
September 16 at 11:00 a.m. “Celebrating 10 years of Patient-Focused Drug Development.” Our guest will be Dr. Theresa Mullin, CDER Associate Director for Strategic Initiatives and one of the pioneers of PFDD. The webinar will be moderated by Mary Dwight of the Cystic Fibrosis Foundation and Ron Bartek of the Friedreich's Ataxia Research Foundation. REGISTER HERE.
Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. As experts in what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.
September 27 at 11:30 a.m. “FDA and One Health.” September 27, at 11:30 a.m. Our guests will include Dr. Steven Solomon, Director of the Center for Veterinary Medicine, and Dr. Namandjé N. Bumpus, FDA’s new Chief Scientist. REGISTER HERE.
“One Health” is an approach to solving health problems by recognizing the interconnection of people, animals, plants, and the environment. FDA is one of many federal agencies that support this approach and encourages its use. The webinar will explain the concept in more detail and feature presentations on how FDA’s work utilizes One Health.