# FDASIA 2012 and the origins of the expedited programmes

Source: https://onco.cc/terms/fdasia-2012/  
OnCo record `fdasia-2012` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The 2012 US law that created Breakthrough Therapy designation and made the paediatric study laws permanent, sitting on top of the 1992 user-fee law that gave the FDA review deadlines and the 1997 law that created Fast Track.

## Summary

United States, federal statute. The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed on 9 July 2012 (Public Law 112-144). Section 902 created Breakthrough Therapy designation; other titles made the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act permanent, reauthorised prescription drug user fees for a fifth time, and created generic and biosimilar user fees. Primary text: the Congress.gov record of S.3187.

The expedited programmes have three statutory parents. The Prescription Drug User Fee Act of 1992 let the FDA charge companies fees in return for review-time goals, which is where the ten-month standard and six-month priority review clocks come from. The Food and Drug Administration Modernization Act of 1997 (FDAMA) created Fast Track designation and wrote accelerated approval into statute as section 506. FDASIA added Breakthrough Therapy for drugs whose early clinical data suggest substantial improvement over available therapy, giving them intensive FDA guidance and senior staff involvement. The FDA's expedited programmes guidance (2014) describes how the four fit together.

What it changed for oncology: cancer drugs receive the largest share of breakthrough designations, and the combination of breakthrough, priority review and accelerated approval is how single-arm response-rate data in a biomarker-defined population became a route to market in a few years. Critics note that designation is announced in press releases and can move share prices while adding no evidence, and that a substantial minority of breakthrough drugs later show no survival benefit.

## Fields

- Kind: Term
- Last checked: 2026-09-17
- Also known as: FDASIA; Food and Drug Administration Safety and Innovation Act; FDAMA; Food and Drug Administration Modernization Act; Prescription Drug User Fee Act; PDUFA
- Tags: law; us

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Safety_and_Innovation_Act
- Wikipedia: https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Safety_and_Innovation_Act
- Congress.gov: S.3187, FDASIA (Public Law 112-144): https://www.congress.gov/bill/112th-congress/senate-bill/3187
- FDA: expedited programmes for serious conditions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

## Connected records

- terms: [21st Century Cures Act](https://onco.cc/terms/21st-century-cures-act/), [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [BLA / NDA / MAA (marketing applications) and PDUFA dates](https://onco.cc/terms/bla-nda/), [Breakthrough Therapy / Priority Review / Priority Voucher](https://onco.cc/terms/breakthrough-designation/), [Fast Track and RMAT designations](https://onco.cc/terms/fast-track-rmat/), [FDORA 2022 accelerated approval reforms](https://onco.cc/terms/fdora-2022/), [Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments](https://onco.cc/terms/fdca/), [Paediatric drug laws: BPCA and PREA](https://onco.cc/terms/bpca-prea/), [RACE for Children Act](https://onco.cc/terms/race-for-children-act/), [Real-Time Oncology Review (RTOR) and Assessment Aid](https://onco.cc/terms/real-time-oncology-review/)
- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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