Some readers have asked why there is a pediatric exclusivity add-on for FDA approvals. These exclusivity extensions are provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), which permits certain new drug applications to obtain an additional six months of exclusivity if the drug manufacturer submits certain FDA-requested information relating to the use of the active moiety in a pediatric population.

Section 505(A) required FDA to develop, prioritize, and publish a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric populations and update it annually. As an incentive to industry to conduct studies requested by the Agency, Section 505(A) provides for a 6-month period of marketing exclusivity (pediatric exclusivity).

Pediatric exclusivity is an add-on to existing marketing exclusivity or patent protection. In general, products with no patent life or exclusivity remaining cannot qualify. Under certain conditions, however, pediatric exclusivity may be granted to a product without remaining exclusivity if the supplemental application itself qualifies for a new exclusivity period under the Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Amendments). For example, an application to extend an approved adult indication to the pediatric population for a product with no patent life or exclusivity remaining could obtain pediatric exclusivity if new clinical studies of safety and efficacy are required for approval. In that case, the pediatric supplement would earn 3 years of marketing exclusivity under the 1984 amendments, to which the additional 6 month pediatric exclusivity would be added.

Pediatric exclusivity attaches to any existing exclusivities (including orphan exclusivity) and to all patent protections listed in the Orange Book for any drug product containing the same active moiety as the drug studied. For studies conducted on an unapproved drug, pediatric exclusivity will attach to any exclusivity or patent protection that will be listed in the Orange Book upon approval of that unapproved drug.

Pediatric exclusivity adds 6 months to the exclusivities and patent protections listed of each drug product for which the party submitting the studies holds the approved new drug application. For example, if the drug product has 5-year, new chemical entity (NCE) exclusivity, the addition of pediatric exclusivity will give the applicant 5 1/2 years of NCE exclusivity.

Pediatric exclusivity does not attach to the end of a patent term extension under 35 U.S.C. § 156; rather, it extends the period during which the approval of a competitor’s ANDA or 505(b)(2) application may not be made effective by FDA. For Paragraph IV certifications, pediatric exclusivity does not attach unless an infringement suit is failed and the 30 month stay provision are triggered under Section 505.

Pediatric studies submitted in a supplemental application for a drug that has already received one period of pediatric exclusivity may qualify the drug to receive another 6-month period of pediatric exclusivity, however the second 6-month period will attach only to the 3 year exclusivity period (under sections 505(c)(3)(D)(iv)) and 505(j)(5)(D)(iv)) granted to the supplemental application for which the studies were completed.

Section 505(A) does apply to OTC drugs that are the subject of approved NDAs. But, only drug products subject to section 505 of the Food, Drug, and Cosmetic Act are eligible for pediatric exclusivity. Biological products that are subject to the Public Health Service Act are not eligible for pediatric exclusivity, even if they have orphan exclusivity or other patent protection.

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