For those of you who troll the CDER web page, you may have noticed that the Office of Generic Drugs (OGD) posted a revision of MaPP 5200.3 entitled “Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications” last night. As reported on October 6, 2013 (here), in an effort to conserve resources and direct those resources to the review of the application OGD had essentially cut off most substantive communications regarding ANDA status. That original MaPP was received like (let’s say) perhaps a brick wall by industry. On October 19, 2014, we reported (here) that OGD had heard the industry loud and clear relative to their concept of communication and transparency, and industry let OGD know that their view was somewhat diametrically opposed to the tenants of the original MaPP. Well now, OGD’s issuance of revision 1 of the MaPP clearly provides industry with much of what they have been asking for.
After much review by OGD and OPQ the new revision brings new communication touch points and empowers the Regulatory Project Manager (RPM) to provide actual status of the 5 review disciplines and covers all ANDAs pre-year 3 ANDAs including cohort year 1 &2 as well as backlog applications (those received prior to October 1 2012. This new transparency starts out with assignment of the RPM at the time of filing (once OGD decides that the application is substantially complete for review) of the ANDA. That will trigger a call from the RPM to the industry contact listed in the application to let the applicant know who their RPM is and what the target Action date is (TAD). There will be two touch points during the review of the application where OGD will entertain calls regarding status – one 6 months prior to the TAD and one three months prior to the TAD.
The RPM will also provide some useful information relative to the status of the 5 review disciplines (i.e., which are complete which are still pending etc.) and will drop the “it’s under review, call back in 6 months” that so many of our industry representatives are so used to hearing. OGD recognizes that firms do need reasonable information on status to make necessary arrangements for ordering material in preparation for launch and to better assess their business decision and plans. In addition RPM will provide advanced notification to the industry contact point listed in the application relative to upcoming regulatory communication such as information requests (IRs), complete response letters (CRLs) or easily correctable deficiencies letters (ECDs) etc. This will assure that the correspondence reaches the proper person in the firm in a timely manner and alert the company that something is coming so it it perhaps does not arrive then company knows to contact OGD. The responses to inquiries at the appropriate touch points should be made within 2 business days.
This MaPP, which can be found here, provides a mechanism for improved communication and transparency within defined limits. Remember, it applies only to pre-year three submissions, and will start at time of filing of the ANDA (there are still about 250 ANDA in the backlog of pre-year three that have not yet been acknowledged) and will also apply to the assignment of TADs for those applications for which a TAD has not yet been assigned. Read the MaPP closely, as it provides the key to determining how and who will be your RPM, how communications will flow for these applications and what information you will be able to receive. This is not only a high improvement over the previous MaPP; it is a swing in the right direction for industry and an enormous amount of work for OGD and their counterparts in the Office of Product Quality (OPQ). Time to give kudos to OGD and OPQ on recognizing just how important accurate and complete information of ANDA status is for the industry. This is going to be a lot of additional work for the RPMs but the result will be hopefully more timely ANDA approvals and timely launches of generic products.
Oh by the way, OGD indicated that the first year three GDUFA submissions just received approval although they would not confirm which application it was. Look for one of the newer ANDA numbers in your quest!
Below is the text of an email from the Director Center for Drug Evaluation and Research to FDA staff relative to the new MaPP discussed above.
From: CDER Center Director
Sent: Tuesday, August 18, 2015 4:20 PM
To: CDER-OPQ-ALL; CDER-OGDALL
Subject: MAPP 5200.3: “Communications with Industry with respect to pre-GDUFA Year 3 Abbreviated New Drug Applications”
To All Staff Working with ANDAs
I am pleased to announce the issuance of the revised, joint Office of Generic Drugs-Office of Pharmaceutical Quality MAPP 5200.3, “Communications with Industry with respect to pre-GDUFA Year 3 Abbreviated New Drug Applications” (available on FDA’s Web site at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM369599.pdf. It will substantially expand our communications with applicants concerning pre-GDUFA backlog, GDUFA Year 1 and GDUFA Year 2 submissions (collectively, “pre-Year 3 submissions”).
Although GDUFA requires us to act on 90% of the submissions in the pre-GDUFA backlog cohort by September 30, 2017, individual pre-Year 3 submissions lack GDUFA goal dates. This makes it hard for industry to plan product launches and conduct other business planning that affects generic drug availability. To facilitate launch planning, we will provide information concerning the review status of pre-Year 3 submissions down to the discipline and sub-quality discipline levels. This will help ensure that quality, affordable generic medicines reach the public at the earliest legally available date.
For example, OGD Regulatory Project Managers will communicate Target Action Dates, periodically update applicants and/or respond to applicant queries concerning the review status of submissions, communicate when certain major deficiencies may be forthcoming, and provide certain advance notifications of regulatory correspondences.
OGD Discipline Project Managers and OPQ Regulatory Business Process Managers will issue Informational Requests for their respective disciplines. Informational Requests are letters sent to request further information or clarification that is needed or would be helpful to allow completion of the discipline’s review. The purpose of these communications is to assure that FDA has all the information necessary to evaluate if the application is approvable or must receive a Complete Response Letter.
To facilitate meaningful communications, we are asking review staff members to refer all questions about the overall status of applications to the appropriate OGD Regulatory Project Manager.
We appreciate all of the ANDA discipline reviewers and project managers working together to expand communications with applicants. Implementing these changes will help us achieve a robust generic drug program.
Janet Woodcock, M.D.
Center for Drug Evaluation and Research