Economic Impact Analyses of FDA Regulations
The Food and Drug Administration conducts economic analyses of all important proposed and final regulations. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action, as well as assessments of the costs, benefits and cost-effectiveness of the most promising alternative actions. The full economic impact analyses of significant FDA regulations are no longer (as of April 2012) published in the Federal Register but are available on this site.
To compare the effects of proposed regulations with the effects of promising alternatives, we estimate both the incremental benefits and costs associated with increasing the stringency of regulation and the incremental foregone benefits and cost savings associated with decreasing the stringency of regulation.
The information on incremental costs and benefits helps FDA management choose which controls to include and which to exclude when presented with the usual smorgasbord of ways to deal with a public health problem. The economic analysis may also point out ways to increase the cost-effectiveness of regulation. For example, the economic analysis may demonstrate that the incremental costs associated with a particular provision are very high, with little or no incremental public health effects. Identifying such provisions enables the FDA to revise proposed regulations in ways that substantially decrease costs without appreciably reducing public health benefits.
Recent Regulatory Impact Analyses
- Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
- Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Proposed Rule
- Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals
- Unique Device Identification System Final Rule
- Food Labeling; Gluten-Free Labeling of Foods
- Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors/ Certification Bodies
- Administrative Detention of Drugs Intended for Human or Animal Use
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex
- Use of Certain Symbols in Labeling
- Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products
- Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
- Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption