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# Find New Ways to Fund Pediatric Research: Study
- URL: https://www.fdaweb.com/find-new-ways-to-fund-pediatric-research-study/
- Published: 2018-09-26T12:00:00.000Z
- Updated: 2026-09-15T00:34:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142450

While the pediatric exclusivity extension has generated new pediatric indications for several drugs, it also has led to substantial rewards to drug manufacturers. That’s the conclusion of a [study](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2702288?ref=fdaweb.com) of pediatric clinical trials reported in *JAMA Internal Medicine*. The study authors from Harvard Medical School and several academic medical centers and private hospitals say that over the long term, direct federal funding of pediatric research may be less expensive for consumers and have similar, or even greater, public health benefits.

The researchers identified 54 drugs that earned the pediatric exclusivity incentive between 2007 and 2012, and evaluated labeling changes from the pediatric studies. They extracted trial details from clinical review documents and used industry estimates of trial costs on a per-patient basis to estimate cost of investment for the trials.

The journal article reports that the studies have provided important information about the effectiveness and safety of drugs used in children. But it also says that the costs to consumers have exceeded the estimated costs of investment for conducting the trials.

“If policymakers determine that the costs to consumers for pediatric exclusivity extensions described in the present study are excessive,” the article concludes, “an alternative would be to set a fixed or predetermined award amount for each requested study, claimable on successful completion of pediatric studies. Such an approach would not require companies to wait several years to recoup capital invested in pediatric research, and it would be less expensive for the public, particularly for products with substantial revenues, in which the extension of the monopoly creates the largest mismatch between the incentive and the cost. Another approach would be direct funding of pediatric trials through the National Institutes of Health.”