Readers of this blog and Premier Consulting clients know that a 505(b)(2) does not have to reference a listed drug (LD) but may do so. Also, we have submitted many applications that do not reference the ‘obvious’ LD because doing so would trigger patent challenges and because we don’t need to reference the LD to gain what we need to reduce the nonclinical or clinical studies normally requried for submission of an NDA. We have used no LD, 1 or several LD’s as needed.

FDA’s Dr. Janet Woodcock affirmed this approach on September 18, 2013, in the FDA response to the Citizen Petition (CP) (entire Docket) filed by Hyman, Phelps & McNamara on behalf of Monosol Rx. The CP requests the FDA to “Refuse to File any 505(b )(2) New Drug Application (NDA) for a Buprenorphine/ Naloxone Drug Product Consisting of a Polymer Film for Application to the Oral Mucosal Membranes Unless Such 505(b )(2) NDA References NDA No. 22-410 (SUBOXONE®)”.  The grounds upon which the CP is based are uncommonly weak – the CP cites the 1999 Draft Guidance, which most practioners (should) know has largely been superceeded by actual practice; the CP did not use a regulation or law as a basis.  The Guidance uses words like ‘should’ which certainly isn’t an exclusionary word.

As Dr. Woodcock states: “For example, in certain cases, a sponsor may rely on FDA’s finding of safety and/or effectiveness for different listed drugs to support different aspects of its development program (e.g., where appropriate, reliance on oral and topical dosage forms containing the same active ingredient to support systemic and local toxicology, respectively).” Further, the Sponsor “should determine which listed drug(s) is most appropriate for its development program, and must establish that such reliance is scientifically appropriate.”