Source: https://www.fdalawblog.net/2014/10/aap-chimes-in-on-pediatric-exclusivity-and-whether-a-written-request-is-a-condition-precedent-to-fda/
Timestamp: 2019-06-20 21:15:11
Document Index: 615312144

Matched Legal Cases: ['§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§505', '§505', '§505']

In recent comments submitted to FDA, the American Academy of Pediatrics (“AAP”) is taking a stand against the relief requested in a June 2014 Citizen Petition (Docket No. FDA-2014-P-0830) submitted on behalf of Merz North America. The petition calls into question the long-held belief that FDA’s issuance of a Pediatric Written Request (“PWR”) is a condition precedent to the Agency awarding a period of 6-month pediatric exclusivity pursuant to the Best Pharmaceuticals for Children Act (“BPCA”) (FDC Act § 505A). According to the AAP, Congress never intended for certain provisions of the BPCA “to be an end-run around the requirement for exclusivity to be granted on the basis of a written request.”
Merz says that the difference between the 2007 and 2012 versions of FDC Act § 505A(h) is significant for two reasons: “First, it includes language referencing written requests which was not present in that particular subsection when Cuvposa was approved,” and “[s]econd, it facially narrows the relationship between studies conducted for pediatric exclusivity and for other required purposes.” Continuing on with the second point, the petition says that the 2010 version of FDC Act § 505A(h) “broadly referenced pediatric studies conducted as required by another provision of law or regulation,” but that the 2012 version of FDC Act § 505A(h) “only references PREA studies by name as being eligible for pediatric exclusivity.”
The upshot of the differences in the statutory text, says Merz, is that for CUVPOSA to have been eligible for pediatric exclusivity under FDC Act § 505A(h) as it existed in 2010, two requirements must have been met: (1) the pediatric studies performed must have been “required by a provision of law (including a regulation);” and (2) the studies must have met the pediatric exclusivity requirements, including completeness and timeliness. And both of these elements were met, argues the company:
In its comments to FDA, the AAP says there is no reason to believe that Congress ever intended to award pediatric exclusivity under the circumstances in which a company was seeking approval for pediatric-only use of a drug:
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.