2017-00795. Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance March 20, 2017.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2016-D-4412 for “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/​regulatoryinformation/​dockets/​default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit written requests for single copies of the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Andrew LeBoeuf, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0503, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.”

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the Hatch-Waxman Amendments) created, among other things, section 505(j) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)). Under section 505(j) of the FD&C Act, an ANDA applicant can rely on FDA's previous finding that the reference listed drug (RLD) is safe and effective so long as the ANDA applicant demonstrates that the proposed drug product and the RLD are the same with respect to active ingredient(s), dosage form, route of administration, strength, and, with certain exceptions, labeling. An ANDA must also include sufficient information to demonstrate that the proposed product is bioequivalent to the RLD, and that the ANDA meets the approval requirements relating to chemistry, manufacturing, and controls. An ANDA generally is not required to be the same as the listed drug it references in certain respects. For example, a generic drug generally can differ from its RLD in certain respects with regard to the device or with respect to inactive ingredients.

Drug products that meet the approval requirements under section 505(j) of the FD&C Act are generally considered by FDA to be therapeutically equivalent to their RLD. Products classified as therapeutically equivalent can be substituted with the full expectation that the generic product will produce the same clinical effect and safety profile as the RLD under the conditions specified in the labeling.

These general principles apply to products submitted in ANDAs, including drug-device combination products. A generic drug-device combination product classified as therapeutically equivalent to the RLD can be expected to produce the same clinical effect and safety profile as the RLD under the conditions specified in labeling. This does not mean, however, that the proposed generic drug-device combination product and its RLD need to be identical in all respects. FDA recognizes that an identical design may not always be feasible and, in certain instances, differences in the design of the user interface for a generic drug-device combination product as compared to the RLD may exist without precluding approval of the generic combination drug-device product under an ANDA. In some instances in which differences exist, certain additional information and/or data relating to the user-interface of the proposed generic drug-device combination product, such as data from comparative use human factors studies, may be appropriate to support approval of the proposed product in an ANDA. The extent to which differences between the proposed product and the RLD affect the approvability of the proposed ANDA product will be evaluated on a case-by-case basis.

This draft guidance provides general principles, including recommendations on threshold analyses, which are intended to assist potential applicants in the identification and the assessment of differences in the design of the user interface of a proposed generic drug-device combination product when compared to the user interface for its RLD.

This draft guidance also provides recommendations on the design and conduct of comparative use human factors studies that may help applicants determine whether design differences identified between the proposed generic drug-device combination product and its RLD would preclude approval as an ANDA under the FD&C Act.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” 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. Electronic Access

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

Dated: January 10, 2017.

Leslie Kux,

Associate Commissioner for Policy.