This is a very interesting article that raises some good points well worthy of consideration published on FDA Law Blog run by Hyman, Phelps & McNamara, In summary the FDA grants an additional period of exclusivity for a licensed product for a period of 6 months, if the sponsor submits requested information relating to the use of the active moiety in the paediatric population. There are a number of rules and regulations involved in obtaining this exclusivity (perhaps a full article on this subject is justified – I will try and get one in this week). However what this interesting article points out is that the FDA’s interpretation of the benefits goes beyond what you may think and their points of view are justified with case studies.

FDA statement

“Pediatric exclusivity will attach to exclusivity and patent protection listed in the Orange Book for any drug product containing the same active moiety as the drug studied and for which the party submitting the studies holds the approved new drug application (505A(a) and (c)).  For studies conducted on an unapproved drug, pediatric exclusivity will also attach to any exclusivity or patent protection that will be listed in the Orange Book upon approval of that unapproved drug.  FDA will attach pediatric exclusivity to protections listed at any time for a drug product as approved at the time pediatric exclusivity is obtained, as described further in section X.C.”

FDA statement

“Previously earned pediatric exclusivity will not apply to new patents or exclusivity covering later-filed applications or supplements containing the same active moiety for which a sponsor previously earned pediatric exclusivity, unless the data that earned the prior pediatric exclusivity is essential to approval of the new application or supplement.”

Interesting interpretation:

When the FDA issues a Paediatric Written Request (PWR) for a drug product that is a racemic mixture, any pediatric exclusivity granted as a result of that PWR applies not only to the to the racemic mixture but also to the sponsors other products containing either enantiomer whether or not FDA’s PWR specifically identifies each enantiomer in the racemic mixture.

previously earned pediatric exclusivity can apply to certain new Orange Book-listed patents if those patents relate back to the drug product when pediatric exclusivity was granted.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.