On April 27, FDA recertified its Manual of Policies and Procedures (“MAPP”) mechanism for abbreviated new drug application (“ANDA”) applicants to request an expedited review of a supplement to an approved ANDA, MAPP 5240.1, Requests for Expedited Review of Supplements to Approved ANDAs. In essence, the procedure recognizes that there are situations where ANDA holders will want expedited review of their ANDA supplements that may concurrently meet or a “public health need” or be in the “government’s best interest.”
FDA’s regulations at 21 C.F.R. Section 314.70(b) provides: “An applicant may ask FDA to expedite its review of a supplement if a delay in making the change described in it would impose and extraordinary hardship on the applicant.” Such requests require, among other things, marking the supplement, “Supplement – Expedited Review Requested.”
FDA’s Office of Generic Drugs (“OGD”) considers requests for expedited review on a case-by-case basis. In addition to the special marking described above, the ANDA holder must provide the basis for expedited review. The government may apply its own need criteria, however, to expedite the supplement without a specific request from the applicant. For the applicant, “extraordinary hardship” reasons include: 1) catastrophic events such as explosion, fire, or storm damage to manufacturing facilities, or 2) events that could not have been reasonably forseen including an abrupt discontinuation of an active ingredient or component of a drug product or relocation of a facility or change in an existing facility due to a catastrophic event. For the government, there either are public health needs such as events that affect the availability of the drug for which there are no alternatives or a nation wide drug shortage, or government needs, including: 1) government drug purchase programs, 2) federal or state/legal regulatory actions including necessary formulation or labeling changes (not as a result of an FDA inspection requiring a new supplement).
According to the MAPP, the initial request should be sent to OGD’s document control room, which will be forwarded to the appropriate review division. ANDA applicants will obtain from the Product Quality Regulatory Project Manager a rationale for any denials. If denied, the ANDA applicant may appeal the decision by providing supporting documentation, referencing the ANDA. The team leader will make an initial recommendation and consult with the division director. The division director’s decision will be final.
While it appears that a version of this MAPP was in effect as of November 1, 1995, FDA’s recertification appears to be motivated by FDA’s proactive efforts to help prevent drug shortages, particularly when unforeseen events occur or the government itself wants to expedite ANDA supplements to prevent ongoing or future drug shortages, including the government’s needs for stockpiling certain drug products for current public health needs or emergency preparedness.