Stop the Presses: FDA Publishes Policy for Granting Requests to Conduct Expedited Reviews of NDA and BLA CMC Prior Approval Supplements

Late last month, CDER’s Office of Pharmaceutical Quality (OPQ) published a MAPP (Manual of Policies and Procedures #5310.3) outlining its policy for granting or denying expedited reviews of NDA and BLA Prior Approval Supplements (PAS) that involve chemistry, manufacturing and controls (CMC) changes overseen by OPQ.

Below are the pertinent highlights of the MAPP:

• An expedited review in the context of this MAPP, is FDA-speak for seeking to assess and act on the PAS prior to the Prescription Drug User Fee Act (PDUFA) goal date associated with that PAS;
• Normally, the sponsor is expected to make the request for expedited review, however, if the public need arises, OPQ may designate the CMC PAS for expedited review of its own initiative;
• OPQ will only consider requests for expedited review that clearly state the basis for the request;
• OPQ can designate a CMC PAS for expedited review at the time it receives the PAS or at any time thereafter. For instance, if OPQ receives a request for expedited review after the office has already processed the PAS, OPQ will consider the request and could still expedite the review of the PAS;
• OPQ will not consider a request for an expedited review that involves a facility that is subject to an OAI recommendation, unless an expedited review will help address a public health concern;
• OPQ will consider an expedited review request for a CMC PAS that falls into one of the following categories:
  • drug shortages;
  • special review programs such as the President’s Emergency Plan for AIDS Relief;
  • public health emergencies;
  • certain government purchasing programs;
  • statutory mandates or other legal requirements;
  • events that constitute extraordinary hardship on the applicant, such as a catastrophic event (eg, storm or fire damage), or the discontinuation of supply of an active ingredient or other material.

As it turns out, the categories for which OPQ will consider an expedited review request for a CMC PAS are not that dissimilar from the ones that the Office of Generic Drugs has previously indicated it will consider for expedited review of ANDAs, ANDA amendments, and ANDA supplements in its MAPP 5240.3, the most recent version of which was published on November 9, 2017. The only difference between the two MAPPs in that regard is that MAPP 5240.3 also includes the following categories, which are a function of the types of applications it reviews:

• submissions containing certain patent certifications and exclusivity statements;
• submissions for “sole source” drug products, i.e., “Submissions for drug products for which there is only one approved drug product listed in the Prescription Drug Product List (i.e., the “active section”) of the Orange Book and for which there are no blocking patents or exclusivities may receive a priority review, except when the approved drug product was approved pursuant to a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act.”

To summarize, the new MAPP 5310.3 for CMC PASs related to NDAs and BLAs is just a logical extension of the pre-existing MAPP 5240.3 for ANDAs, ANDA amendments and ANDA supplements. So, the next time your API supplier’s facility is knocked out by a torrential storm, you’ll know FDA’s position regarding the expedited review of your application or supplement!