Q&A on FDA’s FY23 Appropriation (let us know if you have other questions)

Q: Is the 21st Century Cures monies ($50 million for FY 23) included in the $3.530 billion appropriated?

A: No. Cures money is additional to the monies in the table we reproduced and the numbers we have used in the Alliance’s press release. It is confusing because the $50 million in Cures money mentioned is not BA (taxpayer funding), but monies “derived from savings achieved by cuts made in mandatory programs”

To reinforce this distinction, the appropriations committees always appropriate Cures monies in a completely separate section from FDA BA. Their committees press releases often do not make the distinction even if the bill does.

Q: How can I ascertain the monies that will be available for the specific programs I support?
A: Mostly the answer is “no,” you cannot figure out program allocations based on the annual appropriations bills. The total amount is clarified only by a chart with how much money is appropriated for each Center, the Office of the Commissioner, and rent items.

However, Congress’ expects that the base monies will be spent on continuing programs and initiatives undertaken in FY 22 except to the extent report language specifies amounts for certain programs and initiatives (e.g., Congress always specifies monies to address opioid addiction issues).

Q: I worked to get report language included on the House bill, but it is not mentioned in the Explanatory Statement on the Omnibus. Where do I stand?
A: You succeeded. The joint Explanatory Statement was approved and indicates Congressional intent. It states further that:

Unless otherwise noted, the language set forth in House Report 117-392 carries the same weight as language included in this joint explanatory statement and should be complied with unless specifically addressed to the contrary in this joint explanatory statement. While some language is repeated for emphasis, it is not intended to negate the language referred to above unless expressly provided herein.

Q: What is the significance of so much money allocated for personnel costs?
A: Most of FDA’s base budget is spent on personnel costs (salary, benefits, office, IT, travel, training), which aligns with human resources being FDA’s most valuable asset. If Congress had not appropriated additional monies specifically for personnel costs, then FDA would have had to find the equivalent amount of money out of existing programs.

Q: How much additional funding did food safety receive and how does it relate to reform efforts?
A: Food safety programs will receive an additional $41 million, as well as its share of an $121 million increase that supports cross-cutting initiatives and $21 million in infrastructure investments. Most of the heavy lifting on the appropriations bills was done last Spring and Summer before the groundswell of support for reform of FDA food programs.

As a result, Commissioner Califf will have time to follow through on the Reagan-Udall Foundation report and other commitments that have been made to reform the food safety programs. If that effort is not further along by May/June, then it is possible that appropriators may become involved during the FY 24 appropriations cycle.

Q: What other FDA authorities are included in the Omnibus?
A: According to a release from the House Energy and Commerce Committee (here), the Omnibus modernizes and strengthens FDA’s ability to oversee drugs that are approved through the accelerated approval pathway. The bill requires FDA to specify conditions for required post approval studies and authorizes the agency to require post approval studies to be underway at the time of approval or within a specified time period following approval. The omnibus also clarifies and streamlines the existing authority to withdraw approvals where sponsors fail to conduct studies with due diligence. The omnibus requires FDA to take a series of actions intended to modernize and improve clinical trials including increasing the diversity and engagement of trial participants.
 
The omnibus strengthens FDA’s ability to regulate the safety of cosmetics and personal care products. The bill empowers FDA to establish good manufacturing practices, requires manufacturers to report adverse events, requires manufacturing facilities to be registered, requires cosmetic product labels to list fragrance allergens and contact information to report adverse event reports, and provides FDA with mandatory recall authority.
 
Finally, the omnibus provides a statutory basis for the already-established Advanced Research Projects Agency – Health (ARPA-H), an advanced research entity that will accelerate innovation in health and medicine by investing in novel, broadly applicable, high-risk, high-reward research projects. 

Q: How can I ascertain the monies that will be available for the specific programs I support?
A: Mostly the answer is “no,” you cannot figure out program allocations based on the annual appropriations bills. The total amount is clarified only by a chart with how much money is appropriated for each Center, the Office of the Commissioner, and rent items.
However, Congress’ expects that the base monies will be spent on continuing programs and initiatives undertaken in FY 22 except to the extent report language specifies amounts for certain programs and initiatives (e.g., Congress always specifies monies to address opioid addiction issues).

Q: I worked to get report language included on the House bill, but it is not mentioned in the Explanatory Statement on the Omnibus. Where do I stand?
A: You succeeded. The joint Explanatory Statement was approved and indicates Congressional intent. It states further that:

Unless otherwise noted, the language set forth in House Report 117-392 carries the same weight as language included in this joint explanatory statement and should be complied with unless specifically addressed to the contrary in this joint explanatory statement. While some language is repeated for emphasis, it is not intended to negate the language referred to above unless expressly provided herein.

Q: What is the significance of so much money allocated for personnel costs?
A: Most of FDA’s base budget is spent on personnel costs (salary, benefits, office, IT, travel, training), which aligns with human resources being FDA’s most valuable asset. If Congress had not appropriated additional monies specifically for personnel costs, then FDA would have had to find the equivalent amount of money out of existing programs.

Q: How much additional funding did food safety receive and how does it relate to reform efforts?
A: Food safety programs will receive an additional $41 million, as well as its share of an $121 million increase that supports cross-cutting initiatives and $21 million in infrastructure investments. Most of the heavy lifting on the appropriations bills was done last Spring and Summer before the groundswell of support for reform of FDA food programs.

As a result, Commissioner Califf will have time to follow through on the Reagan-Udall Foundation report and other commitments that have been made to reform the food safety programs. If that effort is not further along by May/June, then it is possible that appropriators may become involved during the FY 24 appropriations cycle.

Q: What other FDA authorities are included in the Omnibus? 
A: According to a release from the House Energy and Commerce Committee (here), the Omnibus modernizes and strengthens FDA’s ability to oversee drugs that are approved through the accelerated approval pathway. The bill requires FDA to specify conditions for required post approval studies and authorizes the agency to require post approval studies to be underway at the time of approval or within a specified time period following approval. The omnibus also clarifies and streamlines the existing authority to withdraw approvals where sponsors fail to conduct studies with due diligence. The omnibus requires FDA to take a series of actions intended to modernize and improve clinical trials including increasing the diversity and engagement of trial participants.
 
The omnibus strengthens FDA’s ability to regulate the safety of cosmetics and personal care products. The bill empowers FDA to establish good manufacturing practices, requires manufacturers to report adverse events, requires manufacturing facilities to be registered, requires cosmetic product labels to list fragrance allergens and contact information to report adverse event reports, and provides FDA with mandatory recall authority.
 
Finally, the omnibus provides a statutory basis for the already-established Advanced Research Projects Agency – Health (ARPA-H), an advanced research entity that will accelerate innovation in health and medicine by investing in novel, broadly applicable, high-risk, high-reward research projects.