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Economic return of clinical trials performed under the pediatric exclusivity program.

Publication ,  Journal Article
Li, JS; Eisenstein, EL; Grabowski, HG; Reid, ED; Mangum, B; Schulman, KA; Goldsmith, JV; Murphy, MD; Califf, RM; Benjamin, DK
Published in: JAMA
February 7, 2007

CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007. OBJECTIVE: To quantify the economic return to industry for completing pediatric exclusivity trials. DESIGN AND SETTING: A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated. MAIN OUTCOME MEASURES: Net economic return and net return-to-cost ratio. RESULTS: The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63). CONCLUSIONS: The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

February 7, 2007

Volume

297

Issue

5

Start / End Page

480 / 488

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Pediatrics
  • Marketing
  • General & Internal Medicine
  • Drug Industry
  • Drug Costs
  • Drug Approval
  • Costs and Cost Analysis
  • Cohort Studies
 

Citation

APA
Chicago
ICMJE
MLA
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Li, J. S., Eisenstein, E. L., Grabowski, H. G., Reid, E. D., Mangum, B., Schulman, K. A., … Benjamin, D. K. (2007). Economic return of clinical trials performed under the pediatric exclusivity program. JAMA, 297(5), 480–488. https://doi.org/10.1001/jama.297.5.480
Li, Jennifer S., Eric L. Eisenstein, Henry G. Grabowski, Elizabeth D. Reid, Barry Mangum, Kevin A. Schulman, John V. Goldsmith, M Dianne Murphy, Robert M. Califf, and Daniel K. Benjamin. “Economic return of clinical trials performed under the pediatric exclusivity program.JAMA 297, no. 5 (February 7, 2007): 480–88. https://doi.org/10.1001/jama.297.5.480.
Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007 Feb 7;297(5):480–8.
Li, Jennifer S., et al. “Economic return of clinical trials performed under the pediatric exclusivity program.JAMA, vol. 297, no. 5, Feb. 2007, pp. 480–88. Pubmed, doi:10.1001/jama.297.5.480.
Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, Goldsmith JV, Murphy MD, Califf RM, Benjamin DK. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007 Feb 7;297(5):480–488.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

February 7, 2007

Volume

297

Issue

5

Start / End Page

480 / 488

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Pediatrics
  • Marketing
  • General & Internal Medicine
  • Drug Industry
  • Drug Costs
  • Drug Approval
  • Costs and Cost Analysis
  • Cohort Studies