Document ID: FDA-2022-D-0528-0001
Agency: fda
Document Type: Notice
Title: Evaluation of Therapeutic Equivalence; Draft Guidance for Industry; Availability
Posted Date: 2022-07-21T04:00Z

[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Notices]
[Pages 43529-43531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15612]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0528]

Evaluation of Therapeutic Equivalence; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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[[Page 43530]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Evaluation 
of Therapeutic Equivalence.'' The draft guidance would explain FDA's 
therapeutic equivalence evaluations, including the assignment of 
therapeutic equivalence codes, if finalized as written. FDA's 
therapeutic equivalence evaluations are listed for multisource 
prescription drug products approved under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) in the active section of the Approved Drug 
Products With Therapeutic Equivalence Evaluations (commonly known as 
the Orange Book). These therapeutic equivalence evaluations have been 
prepared to serve as public information and advice to state health 
agencies, prescribers, and pharmacists to promote public education in 
the area of drug product selection and to foster containment of health 
care costs.

DATES: Submit either electronic or written comments on the draft 
guidance by September 19, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2022-D-0528 for ``Evaluation of Therapeutic Equivalence.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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: Susan Levine, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Evaluation of Therapeutic Equivalence.'' The draft guidance 
would explain FDA's therapeutic equivalence evaluations, including the 
assignment of therapeutic equivalence codes. Therapeutic equivalents 
are approved drug products that are pharmaceutical equivalents for 
which bioequivalence has been demonstrated, and that can be expected to 
have the same clinical effect and safety profile when administered to 
patients under the conditions specified in the labeling.
    FDA's therapeutic equivalence evaluations are listed for 
multisource prescription drug products approved under section 505 of 
the FD&C Act (21 U.S.C. 355) in the active section of the Approved Drug 
Products With Therapeutic Equivalence Evaluations (commonly known as 
the Orange Book). These therapeutic equivalence evaluations have been 
prepared to serve as public information and advice to state health 
agencies, prescribers, and pharmacists to promote public education in 
the area of drug product selection and to foster containment of health 
care costs. For example, the Orange Book can assist in the 
establishment of formularies that States and other entities may use in 
determining when drug products may be substituted for one another. If 
lower-cost, therapeutically equivalent drug products are available, 
American consumers are more likely to receive savings on these products 
without a sacrifice in the quality of treatment.

[[Page 43531]]

    In the Federal Register of June 1, 2020 (85 FR 33165), FDA 
announced the establishment of a public docket to solicit comments on 
the Orange Book, including questions related to the presentation of 
information on therapeutic equivalence (e.g., ``How useful is the 
second letter of a therapeutic equivalence evaluation code?''), which 
also relate to the content of this guidance. FDA is continuing to 
consider the comments to this docket.
    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 ``Evaluation 
of Therapeutic Equivalence.'' 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

    While this draft guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this draft guidance. The previously approved collections 
of information are subject to review by OMB under the PRA. The 
collections of information in 21 CFR 10.30 have been approved under OMB 
control number 0910-0191.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15612 Filed 7-20-22; 8:45 am]
BILLING CODE 4164-01-P