In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction would not make an ANDA product less safe or effective than the reference listed drug.
In this interesting petition response, FDA used its standard arguments relating to statutory and regulatory permissions, as well as past precedents for certain labeling differences from that of the reference listed drug (including those that permit the carve out of certain information or indications that are protected by patent or exclusivity as long as ANDA product that does not include the protected information is not less safe or effective than the reference listed drug upon which it is based).
The Agency addresses each point in the petition in exhaustive detail and provides examples of other carve outs that the Agency has permitted. This is another apparent win in the battle of the “carve outs” of patent- or exclusivity-protected information relative to generic applications. Remember that exclusivity protection for a supplemental application protects only the change supported by the results of new clinical studies (other than bioequivalence studies) upon which the supplement is approved. It is also interesting that the firm submitting the petition requested that 505(b)(2) applications also not include the protected information, but the FDA reminded the petitioner that 505(b)(2) applications do not have to abide by the “same as” labeling requirements as applications submitted under 505(j) and each 505(b)(2) application may be approved on its own merit.
For us old folks, this is nothing new, but for you young bucks (and does), a read of the FDA petition response will provide you with a wealth of knowledge regarding label carve outs and FDA statutory, regulatory stance as well as some historically important past precedents.