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JAMA. 2007 Feb 7;297(5):480-8.

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

Author information

1
Department of Pediatrics, Duke Clinical Research Institute, Duke University, Durham, NC 27705, USA. jennifer.li@duke.edu

Abstract

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.

PMID:
17284698
PMCID:
PMC2773665
[Indexed for MEDLINE]
Free PMC Article

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