Detail on the FDA’s FY 22 funding and implications for the FY 23 cycle.

More Detail on FY 22 Appropriations; Perspectives on FY 23

The Alliance and its Alliance membership--over 150 consumer and patient groups, research advocates, health professions societies, trade groups, companies, and individuals—fought hard for FDA to receive additional resources in FY 22.

The $102 million is a solid step forward and contributes to the requirements of a growing agency. We did not get as much as we hoped or as much as FDA needs, but the FY 22 funding still reflects Congress’ continued commitment to FDA and its growing mission.

Within the $102 million are resources that will go, directly or indirectly, to support FDA’s technology and data modernization efforts. The needs and the opportunities are pressing—better data, more useful information, more informed decision-making—will benefit from a far larger investment in the FDA’s infrastructure We are likely to say even more about this in the FY 23 cycle.

Overall, FY 22 brought progress in FDA funding, but we need to work even harder in the FY 23 cycle. This Friday Update has several ways that you and your organization can contribute—by asking Members of Congress to tell appropriators that FDA is a priority; by becoming more knowledgeable about FDA needs by joining some of our webinars. There will be more opportunities, among them submitting testimony and participating in our Hill Day lobbying. If your organization wants to do more, contact us for ideas and support.

More about FY 22: Under the final bill, FDA’s net increase of $102.2 million is apportioned: $29 million for medical products programs, $29.5 million for food safety, and $41.3 million for cross-cutting initiatives. The FDA bill language is found here and the FDA increases are detailed in the FDA portion of the explanatory statement (here).

Medical Products ($29 million)

• Device Shortages and Supply Chain - $5,000,000;

• CVM Medical Product Supply Chain - $1,500,000;

• Advancing the Goal of Ending the Opioid Crisis - $8,000,000;

• Predictive Toxicology Roadmap - $3,000,000;

• Data Modernization and Enhanced Technology Initiative - $1,000,000;

• Foreign Unannounced Human Drug Inspection Pilots - $5,000,000;

• Rare Cancer Therapeutics - $1,000,000;

• Orphan Products Grants Program - $2,500,000;

• Rare Diseases - $1,500,000; and

• BioFilm Regulatory Research - $500,000

Food Safety ($29.5 million)

• Maternal and Infant Health and Nutrition - $11,000,000;

• Emerging Chemical and Toxicology Issues - $7,000,000;

• New Era of Smarter Food Safety - $9,000,000;

• Animal Feed Reviews - $1,000,000; and

• Standards of Identity - $1,500,000

Cross-Cutting (MP and FS) ($41.3 million)

• Pay Costs - $17,900,000;

• Data Modernization and Enhanced Technologies - $3,000,000;

• Inspections - $10,000,000;

• Office of Minority Health and Health Equity - $4,700,000;

• Office of Laboratory Safety - $1,500,000;

• Office of the Chief Counsel - $2,200,000; and

• Essential Services - $2,000,000

Infrastructure (unspecified) ($2.4 million)

• Infrastructure investments - $2.4 million

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.