May 20, 1998

Final Pediatric Exclusivity List

Arnold & Porter Article
In today’s Federal Register (63 Fed. Reg. 27733), FDA published a notice of availability of a list of drugs that it has designated as high priority for the development of information concerning pediatric uses. The Food and Drug Administration Modernization Act of 1997, 21 U.S.C. 355a(b), requires FDA to develop a "list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population." Inclusion on this list is important for any drug that is still the subject of market exclusivity or of patent protection. If such drugs are included on the list, and the sponsor completes studies requested by FDA in writing within the timeframe FDA specifies and submits acceptable reports of those studies, ANDA approvals will be held up for an additional 6 months after the expiration of market exclusivity or patent protection. 21 U.S.C. 355a(c).
The preamble to the Pediatric Exclusivity List FDA has just issued, but curiously not the Federal Register notice, makes it clear that this list is not the list the statute describes. FDA has concluded that all drugs approved in adults for an indication that occurs in the pediatric population "are considered to be on the list" of drugs referred to in the statute. The list that FDA actually published is thus a subset of the "list" contemplated by the statute and includes drugs FDA considers to be high priority, for which FDA will issue written requests for studies first.

Several points about FDA’s action are noteworthy:

o FDA, rejecting an industry suggestion, has stated that inclusion on the priority list is not, in and of itself, the written request for studies required by the statute as a prerequisite for exclusivity.

o FDA states that FDA’s written request will not extend to uses of drugs in the pediatric population for indications not approved in adults. Such indications may, FDA suggests, qualify for exclusivity under another provision of the statute, 21 U.S.C. 355a(a). It is not clear whether use of a new dosage form designed for the pediatric population but for the same indication as the adult dosage form would be considered, for these purposes, a new indication.

o The statute requires FDA to update its list annually. FDA states, however, that it will update the priority list on a "regular basis," presumably more often than annually.

o FDA states that any party wishing to have a drug placed on the priority list, or removed from the priority list, is to make that request by the filing of a citizen petition pursuant to 21 C.F.R. 10.30.

o Drugs not on the priority list may become eligible for exclusivity if FDA issues a written request for pediatric studies with respect to the drug. FDA states that it will issue study requests for drugs on the priority list "first." It is possible that the prioritization may be within divisions. Thus, when FDA has issued requests with respect to each priority list drug within a division’s purview, it may then turn to other drugs for which that division is responsible that are not on the priority list.

Update: Several important issues are not addressed in the list but are addressed in the guidance FDA later issued. See our memo on that guidance on this web site.

The FDA Pediatric Exclusivity List can be accessed by clicking on the highlighted term in the second paragraph of this memo or can be accessed on the internet at
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