2015-24621. Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development”. The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Maryll Toufanian, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 75, Rm. 1684, Silver Spring, MD 20993-0002, 240-402-7944, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development”. The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence.

Under the provisions of the Generic Drug User Fee Amendments of 2012 (GDUFA), FDA agreed to certain obligations as laid out in the Generic Drug User Fee Act Program Performance Goals and Procedures for fiscal years 2013 through 2017 (the GDUFA Commitment Letter) that accompanies the legislation (Ref. 1). Among those obligations is FDA's commitment to performance metrics for its responses to controlled correspondence for fiscal years 2015 through 2017.

This guidance finalizes the draft guidance announced in the Federal Register on August 27, 2014 (79 FR 51180). The Agency considered comments on the draft guidance while finalizing this guidance. Generally, we revised the draft guidance to provide clarifying and explanatory information that will assist human generic drug manufacturers and related industry as they submit controlled correspondence to FDA. Changes from the draft guidance include a description of a process to submit information to update the Agency's Inactive Ingredient Database and a description of enhanced communication to requestors regarding the status of their controlled correspondence.

Two comment threads on the draft guidance benefit from additional discussion here. Specifically, FDA received numerous comments regarding two categories of requests that FDA proposed in the draft guidance to exclude from the controlled correspondence process. First, FDA received comments requesting that the Agency refrain from excluding requests for product-specific guidance on demonstrating bioequivalence. FDA declines to revise the guidance in this fashion. As set out in the draft guidance, the short timeframe contemplated for the controlled correspondence responses is inconsistent with the well-established process for issuing product-specific recommendations described in the guidance for industry on “Bioequivalence Recommendations for Specific Products (June 2010)”, as well as with the principles in the GDUFA Commitment Letter regarding the Regulatory Science Initiative. Rather than incorporating such guidance development into the controlled correspondence process, FDA's Office of Generic Drugs (OGD) is developing a separate process for product-specific guidance development.

This approach is being managed by the Division of Therapeutic Performance (DTP) within OGD's Office of Research and Standards, involves representatives from numerous divisions and offices within OGD, and provides for timely posting of product-specific recommendations to facilitate generic drug development. Requests for product-specific guidance development received through the general [e-mail] email account are forwarded directly to DTP for consideration and tracking. Prioritization of guidance development is based on a variety of factors, including public health needs, industry demand for generic development, anticipated expiration of reference listed drug exclusivity, formulation features and predictability of in vivo performance, OGD experience with similar formulations or product types, and the feasibility of different approaches to demonstrate bioequivalence (e.g., pharmacokinetic/pharmacodynamics studies, comparative clinical endpoint studies, and in vitro approaches). FDA anticipates that this targeted development approach will expedite the availability of product-specific guidances while supporting the important policies of transparency and maximizing benefit to the public health.

Second, FDA received comments regarding its proposed method of responding to requests related to issues for which the Agency has not yet determined a policy. Upon review of the comments, FDA is revising its recommendations related to such inquiries. As described in the guidance, if there is a better mechanism for a requestor to obtain comment from FDA on the subject of the request than through a controlled correspondence, the Agency will direct the requestor to such a mechanism, e.g., a pre-abbreviated new drug application meeting request or the Regulatory Science Initiative. For requests for which the controlled correspondence pathway is the best mechanism, but that raise issues for which FDA has not determined appropriate policy, such requests will remain open until such policy decision is made.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on controlled correspondence related to generic drug development. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information has been approved under OMB control number 0910-0797.

III. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

V. Reference

The following reference has been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov.

(FDA has verified the Web site address in this reference section, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

1. Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA Commitment Letter) for fiscal years 2013 through 2017, available at http://www.fda.gov/​downloads/​ForIndustry/​UserFees/​GenericDrugUserFees/​UCM282505.pdf.

Dated: September 22, 2015.

Leslie Kux,

Associate Commissioner for Policy.