2022 Budget for Public Health Infrastructure and Product Safety Programs

Requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget

  • $185 million in additional investments in FDA’s Critical Public Health Infrastructure
  • $97 million in additional investments in Core FDA Safety Programs
  • $61 million in additional investments in Public Health Issues Confronting the U.S.


Enhance Equity Initiative

Enhance Equity Initiative to promote and protect the health of racial and ethnic minorities, underrepresented and underserved populations through research and communication strategies that address health disparities


Enhance US Drug Supply Chain

Efforts to enhance supply chain to ensure quality of prescription drugs and safeguard integrity of pharmaceutical distribution 

Key Focus Areas for Regulatory Science Investment and Innovation

Office of Regulatory Science and Innovation (ORSI) supports cross-agency collaborative programs aligned with FDA’s strategic priorities for advancing regulatory science

  1. Increasing Choice and Competition through Innovation 
  2. Unleashing the Power of Data
  3. Empowering Patients and Consumers
  4. Public Health Emergency Preparedness and Response

The fourth was added post COVID experience.


Office of Science and Engineering Laboratories (OSEL) updates


HHS grant to expand CURE ID platform for COVID-19 treatments

$9.2 million grant for expansion of the CURE ID platform for COVID-19

  • CURE ID allows global clinical community to share novel uses of existing drugs for challenging infectious diseases
  • New expansion will allow automated data collection from electronic health records (EHR) worldwide and clinical disease registries for COVID-19
  • Will enable health care providers and researchers access to comprehensive (de-identified) case reports on tens of thousands of patients, including treatment outcomes, such as recovery, deterioration, hospitalization, ICU admission, and death


Cosmetics Are Not FDA-Approved, but Are FDA-Regulated

Cosmetic definition: Intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance

  • does not require cosmetic products and ingredients, other than color additives, to have FDA approval
  • must ensure safety of product
  • laws and regulations for interstate commerce e.g. prohibition of adulterated or misbranded cosmetics in interstate commerce
  • cannot make therapeutic claims such as for treating or preventing disease, or to affect the structure or function of the body


Image credit: FDA