Hello. My name is Priya Shah, and I'm a Project Manager in the Office of Regulatory Operations in the Office of Generic Drugs.  This presentation covers requests for reconsideration in GDUFA II.  I'll talk about what is new and what has changed; the impact on both FDA and industry; roles and responsibilities; and how FDA evaluates the request.  Finally, I'll share resources available to help assist in the submissions.  

Let's begin with a reminder on the background of the dispute resolution process established prior to GDUFA II.  The appropriate course of action for an applicant who disagrees with a decision made by the Agency is to first request reconsideration of the matter by the original signature authority before the issue may be appealed to the next higher management level.  If the matter cannot be resolved through the request for re-consideration process, the applicant may pursue formal dispute resolution above the division level. 

Formal disputes follow the procedures set forth in the guidance “Formal Dispute Resolution: Appeals Above the Division Level.”  The GDUFA I goal was to aspire to respond to an appeal of a formal dispute within 30 calendar days of the center's receipt of the written appeal.

Now, let's take a look at what is new or has changed from GDUFA I for both the FDA and Industry. In GDUFA II, a goal date will be applied to formal dispute resolutions above the division level.  FDA will respond within 30 calendar days of receipt of the written appeal pursuant to the applicable fiscal year goal. 

Prior to an applicant pursuing a formal dispute, the applicant must try to resolve the issue through the request for reconsideration process.  GDUFA II formalized FDA's current and historical practices in regards to these requests with the issuance of a new draft guidance specific to Requests for reconsideration.

As a general matter, FDA will review and respond to these requests as quickly as possible.  In addition, a goal date will be applied to the reclassification of a major amendment or standard review status, upon FDA's receipt of the written request. 
From here on out, the focus of this training will be on the request for re-consideration process. 

So what is the impact of these new or changed processes? First, goal dates applied to requests to reclassify major amendments and standard review status will allow for predictable timelines for industry to ensure that their issues are being promptly addressed and tracked. 

Second, by creating a formalized process for requests for reconsideration, FDA can maintain consistency and provide timely communications.  In addition, the request for reconsideration process closely models the formal dispute resolution process, which will allow for more consistent communications to industry. 

Third, with the publication of the guidance on requests for reconsideration, FDA and industry will gain clarity on the process and procedures.  The guidance clearly explains considerations that an applicant should take prior to submitting a request for re-consideration. 

The guidance addresses both matters that are appropriate to address through this process, and matters that are not appropriate to address through this process. It also discusses how the FDA will apply GDUFA II goals for reconsideration requests to
ANDAs, prior approval supplements, and their associated amendments.  Lastly, the guidance outlines the proper procedures for submitting these requests and discusses FDA's process for reviewing and responding to a request for re-consideration. 

In GDUFA II, both FDA and ANDA applicants have distinct responsibilities. The applicant is responsible for submitting an appropriate request for reconsideration within the specified timeframe, in order to be eligible for a GDUFA goal date.  Requests for reconsideration should be submitted in the manner outlined in the guidance, with courtesy copies being sent to the appropriate individuals.  Any request for reconsideration should include information that helps explain the nature of the scientific and/or regulatory issue, and that will assist the signatory authority in determining the necessary steps to resolve the matter quickly and efficiently.  The content and format of the information that should be provided in the request for reconsideration is outlined in the guidance. 

Project Managers are responsible for conducting a preliminary review of the applicant's request for reconsideration to evaluate whether the request satisfies the procedural criteria so that the request for reconsideration can be accepted.  If the applicant's request for reconsideration is accepted, the project manager will forward this request to the signatory authority.  The project manager also is responsible for sending the applicant an acknowledgment letter identifying the signatory authority, and if applicable, the GDUFA goal date and the date of a teleconference.  If the applicant's request is not accepted, the project manager will inform the applicant on behalf of the signatory authority, and identify the reason why the request was not accepted.  The project manager will also serve as the applicant's point of contact for the request for reconsideration. 

The original signatory authority is responsible for reviewing the request for reconsideration once the request has been deemed accepted for review.  The signatory authority may consult with subject matter experts regarding the matter under reconsideration. 

Finally, the signatory authority will provide the applicant with a final written decision, either granting or denying the request.  To note, the original signatory authority may delegate their request for re-consideration to another deciding official. 

The Associate Director of Operations will be responsible for tracking each request for division level reconsideration through resolution. 

In addition, this individual will serve as the administrative contact for the FDA and industry for all procedural related issues regarding requests for reconsideration.  Contact information will be provided later in this training. 

Now that we have gone through the process for a request for reconsideration, how will this process be evaluated?

FDA will track all applicable requests for reconsideration submitted under the ANDA program.  Each request will be assessed to determine whether the request is an appropriate matter for re-consideration, and whether the request satisfies the procedural criteria outlined in the guidance.  FDA will also track timelines of all requests for reconsideration, not only ones eligible for GDUFA II goal dates.  FDA will review and respond to all requests for reconsideration as expeditiously as possible.  In addition,

FDA will make every effort to either meet or exceed the 90% metric for requests pertaining to the reclassification of a major amendment or standard review status. With the enhanced tracking system, FDA will be able to track the outcomes of each of the requests, as well as the general theme of the request.  With this data, the FDA will be able to continuously improve our practices and procedures. 

Applicants can promote success by adhering to best practices when submitting requests for reconsideration.  Applicants should only submit requests for re-consideration if they are appropriate matters for this process.  No new information should be submitted as part of a request for reconsideration.  FDA's reconsideration of a decision that has been requested by an applicant must be based on the same information that was relied upon to make the original decision, meaning information previously submitted to the ANDA

If the matter is appropriate to submit, applicants should include information that is adequate to explain the nature of the matter in the format that will allow the signatory authority to quickly and efficiently resolve the matter.  Applicants should submit these requests within seven calendar days from the date of the regulatory action taken by FDA.  This ensures that the request for reconsideration is regarding a recent Agency regulatory action.  In addition, the applicant should not actively engage with other entities within FDA, or pursue other regulatory or legal pathways on the same matter at the same time, as this may impede FDA's consideration of a request for reconsideration. 

Lastly, we highly recommend emailing a copy of the request for reconsideration to the ANDA reconsideration account, [email protected].  A copy should also be sent to other appropriate email addresses identified in the guidance.  This will assist the FDA in promptly reviewing the applicant's issue. 

For additional information, please review the resources available to applicants and FDA staff. The GDUFA II Commitment Letter and Guidances on formal dispute resolution and requests for re-consideration are available on the FDA website.
For questions on this process, please contact the Associate Director of Operations at the ANDA reconsideration email address. Thank you for your time and I hope you now have a better understanding about the request for reconsideration process.