Source: http://www.fdalawblog.net/2014/10/aap-chimes-in-on-pediatric-exclusivity-and-whether-a-written-request-is-a-condition-precedent-to-fda/
Timestamp: 2019-04-23 02:00:18+00:00

Document:
Exclusivity under this section shall only be granted for the completion of a study or studies that are the subject of a written request and for which reports are submitted and accepted in accordance with subsection (d)(3). Written requests under this section may consist of a study or studies required under section 355c of this title [FDC Act § 505B].
Cuvposa met the first hurdle for receiving pediatric exclusivity under § 505A(h) because the sponsor was required to complete pediatric studies for NDA approval under both the FFDCA and the regulations. . . . Cuvposa also cleared the second hurdle for pediatric exclusivity under § 505A(h) — that the studies meet the “completeness, timeliness, and other requirements” for exclusivity. The completeness requirement was certainly met because, if not, then the NDA would not have been approved. The timeliness factor is not relevant here, because the studies were completed as required for NDA approval. As far as any of the “other requirements” — a written request, internal review of the request, and internal review of the completed studies — none of these were required for Cuvposa to be eligible for exclusivity under § 505A(h).
To argue that Congress intended to allow for the awarding of pediatric exclusivity under §505A(i)/§505A(h) for studies submitted in accordance with a pediatric-only new drug application under §505(b)(1), requires one to also argue that Congress also intended pediatric exclusivity to be an incentive for the development of new pediatric-only therapies. There is no factual basis to make this claim and no record to indicate this is what Congress intended. While improving incentives for the development of first-in-pediatrics therapies is a worthy goal, the goals of the Pediatric Rule, BPCA, and PREA is and always has been to ensure that drugs developed for adults are studied in children and to provide incentives for completing additional FDA-requested studies in children.
The written request is and always has been an essential element of the pediatric exclusivity program. Six months of exclusivity is a powerful incentive for manufacturers but it does not come without a cost to society. Tying this incentive to the fulfillment of a written request allows the FDA to ensure that the data generated by trials involving children are maximized, that product sponsors are meeting the objectives and timeframes agreed to in the written request, and that data and labeling generated by such trials are available to the public. It would be a dangerous precedent to allow the awarding of exclusivity without a written request. The written request is in essence a contract between the FDA and the sponsor to conduct specific pediatric studies in return for a generous incentive. Allowing the awarding of exclusivity without a written request would not appropriately serve the interests of child health.

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