GDUFA II: Requests for Reconsideration

Priya Shah, Pharm.D.Immediate Office Project Manager

Office of Regulatory Operations, Office of Generic Drugs

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Purpose

• To provide an overview of requests for reconsideration under GDUFA II with a focus on industry impact

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Commitment Letter Language• II. Original ANDA Review Program Enhancements

– C. Review Classification Changes During the Review Cycle• 6. If an applicant requests a teleconference as part of its request to

reclassify a major amendment or standard review status, FDA will schedule and conduct the teleconference and decide 90% of such reclassification requests within 30 days of the date of FDA’s receipt of the request for a teleconference. This goal only applies when applicant accepts the first scheduled teleconference date offered by FDA.

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Commitment Letter Language• II. Original ANDA Review Program Enhancements

– E. Dispute Resolution• 1. An applicant may pursue a request for reconsideration within the

review discipline at the Division level or original signatory authority, as needed.

• 2. The OGD Office of Regulatory Operations Associate Director will track each request for Division level reconsideration through resolution.

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Commitment Letter Language• II. Original ANDA Review Program Enhancements

– E. Dispute Resolution• 3. Following resolution of a request for reconsideration, an applicant may

pursue formal dispute resolution above the Division level, pursuant to procedures set forth in the September 2015 Guidance, Formal Dispute Resolution: Appeals Above the Division Level.

• 4. FDA will respond to appeals above the Division level within 30 calendar days of CDER’s receipt of the written appeal pursuant to the applicable goal.

– a. In FY 2018, the goal is 70 percent.– b. In FY 2019, the goal is 80 percent. – c. In FY 2020, 2021, and 2022 the goal is 90 percent.

• 5. CDER’s Formal Dispute Resolution Project Manager (or designee) will track each formal appeal above the Division level through resolution

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Working Group Organization

Center for Drug Evaluation and

Research

Office of Generic Drugs

Office of Regulatory Operations

Office of Generic Drug Policy

Office of Bioequivalence

Office of Research and Standards

Office of New Drugs

Office of Pharmaceutical

Quality

Office of Process and Facilities

Office of Lifecycle Drug Products

Office of Policy for Pharmaceutical

Quality

Office of Program and Regulatory

Operations

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What is New/Changed?

• GDUFA II Performance Goals• Guidance for Industry• Standardized Process for Requests for

Reconsideration

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GDUFA II Performance Goals• Schedule, conduct teleconference, and decide 90% of

reclassification requests of a major amendment or standard review status within 30 days of receipt* of the request

• Respond to appeals above the Division level within 30 calendar days of CDER’s receipt of the written appeal – In FY 2018, the goal is 70 percent. – In FY 2019, the goal is 80 percent. – In FY 2020, 2021, and 2022 the goal is 90 percent.

*received by the FDA via the Electronic Submissions Gateway (ESG)

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Guidance for Industry

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Guidance for Industry• Outlines considerations for applicants before submitting a

request for reconsideration– Matters that are not appropriate for a request for reconsideration

will not be accepted for review– A request for reconsideration that includes new information will

not be accepted for review • Outlines timelines and procedures for submitting and

responding to a request for reconsideration– Written request via Electronic Submissions Gateway – Cover letter identifies submission as a “Request for

Reconsideration”

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Process for Requests for Reconsideration

ANDA applicant submits request for reconsideration via

ESG

Project Manager conducts a

preliminary review of the request to

evaluate whether the request should

be accepted

If request is accepted, original

signatory authority will evaluate and

send a written decision to the

applicant

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Who is Responsible?• Applicant• Project Manager• Original Signatory Authority • Associate Director of Operations

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Applicant Responsibilities• Submits request for reconsideration to the

ANDA file – Should not submit a request for a matter that is not

appropriate for this process – Should not include new information in the request

• FDA encourages the applicant to submit the request according to the draft guidance

– Submit courtesy copies to the appropriate individuals

– Submit within 7 calendar days from the date of the regulatory action

– Identify the request as a “Request for Reconsideration” on the cover letter

ANDA applicant submits request for

reconsideration via ESG

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Project Manager Responsibilities• If request is not accepted for review

– Inform the applicant on behalf of the signatory authority

– Identify the reason why the request was not accepted

• If request is accepted for review – Forward the request to the signatory authority – Send the applicant an acknowledgement letter

• identifying the signatory authority • including the GDUFA goal date, if applicable • including the date of the teleconference, if

applicable

Project Manager conducts a preliminary

review of the request to evaluate whether the

request should be accepted

Project Manager conducts a

preliminary review of the request to evaluate whether

the request should be accepted

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Original Signatory Authority Responsibilities

• Review the request once it has been deemed accepted for review

• May consult with subject matter experts regarding the matter under reconsideration

• Provide the applicant with a final written decision either granting or denying the request

*the original signatory authority may delegate their request for reconsideration to another deciding official*

Project Manager conducts a preliminary

review of the request to evaluate whether the

request should be accepted

Project Manager conducts a

preliminary review of the request to evaluate whether

the request should be accepted

If request is accepted, original signatory

authority will evaluate and send a written

decision to the applicant

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Associate Director of Operations Responsibilities

ANDA applicant submits request for

reconsideration via ESG

Project Manager conducts a preliminary review of the request to evaluate

whether the request should be accepted

If request is accepted, original signatory

authority will evaluate and send a written

decision to the applicant

• Track each request for division level reconsideration through resolution

• Serve as the administrative contact for the FDA and industry for all procedural related issues regarding reconsideration requests

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What should Industry expect?

• Predictable timelines for responses to requests for reconsideration

• Receipt of Not Accepted letters for requests that contain new information or that are not appropriate for this process

• Teleconferences to discuss the issue(s), but not opportunities to seek a decision from FDA

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What can Industry do to assist?

• Send courtesy copy to appropriate individuals identified in the draft guidance

• Submit within 7 calendar days from the date of the regulatory action

• Identify the request as a “Request for Reconsideration” on the cover letter

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Tips for Industry• Do not submit requests for matters that are not

appropriate for this process, including, but not limited to:

– Information requests and discipline review letters – General advice letters and advice communicated

during meetings or teleconferences– Meeting minutes

• Do not submit new information as part of the request

• Do not submit for reclassification of a Major amendment to an easily correctable deficiency, information requests, or discipline review letter

– The review cycle has been closed by FDA by taking the action of issuing the complete response letter

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Resources• GDUFA II Commitment Letter: GDUFA

Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022

• Draft Guidance for Industry: Requests for Reconsideration at the Division Level Under GDUFA

• Draft Guidance for Industry and Review Staff:Formal Dispute Resolution: Appeals Above the Division Level

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External Contact

• Inquiries related to specific requests: contact the project manager

• Inquiries related to the process: contact the Associate Director of Operations at ANDAReconsideration@fda.hhs.gov