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  • 2021
  • Working Paper

Regulatory Approval and Expanded Market Size

By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
  • Format:Print
  • | Language:English
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Abstract

Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality certification. We combine data on FDA approvals for follow-on indications and patient-level data on utilization, and examine whether FDA approval of a follow-on indication increases the use of a drug for that indication. We find 5 facts for the market-expanding role of regulation: (1) follow-on approvals increase the share of patients taking a drug with that indication by 4.1 percentage points, or 40% increase over baseline use, at the time of approval; (2) there is little market learning prior to or following the approval of the follow-on indication, suggesting that such approvals fully certify the new use; (3) the effect of these approvals is larger for uses in a different disease area than previous indications, an increase equivalent to over 4 ½ years of market-learning; (4) it is FDA approval, not the initiation of clinical trials that generate the expansion in market size; (5) the market expansion is consistent with physicians prescribing the medicines more because of higher perceived benefits, not reduced administrative costs.

Keywords

New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry

Citation

Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
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About The Author

Amitabh Chandra

Technology and Operations Management
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More from the Authors
  • Vertex and the Cure for Type 1 Diabetes By: Amitabh Chandra, William J Anderson and Silvia Mare
  • Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Floor? By: Katherine Baicker, Amitabh Chandra and Mark Shepard
  • Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
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