Controlled Correspondence Guidance for Generic Development Issues Today!

As part of its GDUFA commitments the FDA has issued a Draft Guidance entitled Guidance for Industry – Controlled Correspondence Related to Generic Drug Development (here). FDA makes clear in this document that controlled correspondence (CC) does not include Citizen Petitions, petitions for reconsideration or stay requests.

The document provides detail and recommendations on:

    • what inquiries FDA considers as controlled correspondence for the purposes of meeting the Agency’s GDUFA commitment;
    • what information requestors can include in a controlled correspondence to facilitate FDA’s consideration of and response to a controlled correspondence; and
    • what information FDA will provide in its communications to requestors that have submitted controlled correspondence.

While there has never been an official Office of Generic Drug’s (OGD) definition of a CC, for purposes of meeting the GDUFA goals OGD is defining a CC as:

A correspondence submitted to the Agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development.

OGD further clarifies that if an issue is raised in a CC that is also raised in a Citizen Petition that the goal date for a response to the CC will begin only after the FDA answers the specific petition that raises the similar issue.

There is also a “limbo” CC wherein the Agency may be considering a particular complex issue for which they have not yet reached a decision.  According to the draft guidance OGD will inform the submitted of the CC that such is the case and will close out the CC at that time.  OGD notes that such issues usually result in the development of a guidance to address the issue.

OGD has also defined some exceptions to the GDUFA goal dates on CCs.  Historically requests for bioequivalence (BE) recommendations, BE protocols and requests for meetings have been treated as controlled correspondence but will no longer be treated as such as the development of responses to these issues can require considerable input from multiple disciplines or other offices in CDER. In addition there is a process in place for review of BE guidance which allows OGD to respond to the general public once a guidance recommendation is established.  Responding to individual requests would place an undue burden on the program. There is also a program in place for the review of meeting request and BE protocol that wil continue to be followed outside of the CC process.

Other issues OGD considers outside of the CC definition include:

    • Questions regarding an ANDA status
    • Inquiries that are not related to drug development (e.g.,  questions on OGD administrative practices or development of aa drug not yet approved in the US)
    • General questions not related to the development of a specific product will not be assigned a GDUFA goal date.

In a big shift, OGD has defined the types of entities that it will consider eligible to submit CC under GDUFA goals which include only drug manufacturers and related industry.  FDA says: “[I]nquiries related to generic drugs submitted by other parties (for example, private citizens, financial firms, or public advocacy groups that are not directly involved in developing generic drug products) should be directed to CDER’s Division of Drug Information.”

The Guidance notes that CCs should be submitted electronically to GenericDrugs@fda.hhs.gov and the emails must be from a corporate email address as OGD will not consider CCs from general or personal accounts as a CC subject to GDUFA goals and will not address them.

Information on the content of a CC is provided and FDA notes that foreign entities must have a US Agent or representative identified and they must have a secure email address to which FDA will provide a response.  Other details on CC content can be found in the document but the Agency makes clear that the requestor must have done its homework and provide detailed and concise information relative to the request before OGD will consider a response.  In other words, no more overly broad questions will be entertained or considered under the CC program or GDUFA goals.

Specific recommendations are made relative to inactive ingredient level requests and, Q1 and Q2 determinations and the guidance also outlines the various disciplines to which CC would typically be addressed.

FDA also outlines how it will respond to the requestor when a CC is received, and how a response will be issued.  OGD will communicate whether it believes the CC complies with this policy or whether OGD does not consider it a CC.  FDA also notes that they:

“[r]ecognize that upon receipt of FDA’s response to a controlled correspondence, requestors might have follow-up questions or requests for related, additional information. Because Agency staff will have to expend resources to review and respond to these follow-up questions and requests for additional information, FDA will treat the requests as new controlled correspondence. In these instances, we recommend that a requestor submit a new controlled correspondence and include the controlled correspondence tracking number(s) of the previous inquiry to facilitate FDA’s review and response.”

This begins a new era of communications with OGD.  Like ANDA status, OGD has indicated they don’t plan on providing update on the status of pending CC requests.    Well, now we know the FDA expectations as to what is in a CC, who may submit them, how to submit them and how FDA will respond.  Now we need to see how the new Draft Guidance will work in practice.  Below are the metrics and goal dates for CCs during cohort years 3-5 of the program:

    • FDA will respond to 70 percent of controlled correspondence in 4 months from date of submission in fiscal year (FY) 2015.
    • FDA will respond to 70 percent of controlled correspondence in 2 months from date of submission in FY 2016.
    • FDA will respond to 90 percent of controlled correspondence in 2 months from date of submission in FY 2017.
    • If the controlled correspondence requires input from the clinical division, one additional month will be added to the goals outlined above.