[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Pages 14948-14949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0065]
Competitive Generic Therapies; 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 final guidance for industry entitled
``Competitive Generic Therapies.'' This guidance provides a description
of the process that applicants should follow to request designation of
a drug as a competitive generic therapy (CGT) and the criteria for
designating a drug as a CGT. In addition, this guidance includes
information on the actions that FDA may take to expedite the
development and review of an abbreviated new drug application (ANDA)
for a drug designated as a CGT. Further, this guidance provides
information on how FDA implements the statutory provision for a 180-day
exclusivity period for certain first approved applicants that submit
ANDAs for drugs designated as a CGT. This guidance finalizes the draft
guidance of the same title dated February 19, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on March 16, 2020.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2019-D-0065 for ``Competitive Generic Therapies.'' 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.
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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.
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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Competitive Generic Therapies.'' This guidance finalizes the
draft guidance of the same title dated February 19, 2019.
On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA)
(Pub. L. 115-52) was signed into law. Section 803 of FDARA amended the
Federal Food, Drug, and Cosmetic Act to add section 506H (21 U.S.C.
356h), which established a new process to designate and expedite the
development and review of certain drugs for which there is ``inadequate
generic competition.'' FDA recognizes that various factors may
influence a generic drug applicant's decision to develop a certain
drug, including drugs with
[[Page 14949]]
inadequate generic competition. For instance, some drugs may not
attract a high level of interest from generic drug applicants if there
is a limited market for the products and/or if the products are more
difficult to develop. Nevertheless, these drugs can play an important
role in diagnosing, treating, and preventing various types of diseases
or conditions, and incentivizing generic competition for these products
can help ensure that patients have access to the medicines they need.
The provisions associated with CGTs are intended to incentivize
effective development, efficient review, and timely market entry for
drugs for which there is inadequate generic competition.
This guidance provides a description of the process that applicants
should follow to request designation of a drug as a CGT and the
criteria for designating a drug as a CGT. Also, this guidance includes
information on the actions that FDA may take to expedite the
development and review of ANDAs for drugs designated as a CGT. These
actions may help to clarify applicants' regulatory expectations for a
particular drug, assist applicants in developing a more complete
submission, and ultimately both promote a more efficient and effective
ANDA review process and help reduce the number of review cycles
necessary to obtain ANDA approval. In addition, this guidance provides
information on how FDA implements the 180-day exclusivity period under
FDARA for certain first approved applicants that submit ANDAs for drugs
designated as CGTs. FDARA created a new type of 180-day exclusivity,
different from 180-day patent challenge exclusivity, for the first
approved applicant of a drug with a CGT designation for which there
were no unexpired patents or exclusivities listed in the Orange Book at
the time of original submission of the ANDA. This new 180-exclusivity
under FDARA (``CGT exclusivity'') is intended to incentivize
competition for drugs that are not protected by a patent or exclusivity
and for which there is inadequate generic competition.
This guidance finalizes the draft guidance entitled ``Competitive
Generic Therapies'' issued on February 19, 2019 (84 FR 4826). FDA
considered comments received on the draft guidance as the guidance was
finalized. Editorial changes were made to clarify that each applicant
should request CGT designation for a drug product that is subject of
their application. We have also clarified that, although FDA may
expedite development and strive to act on applications for drug
products with a CGT designation prior to the Generic Drug User Fee
Amendments (GDUFA) goal date, a CGT designation does not result in a
shorter GDUFA goal date. Additional explanation was also added to note
that pre-ANDA meetings may be granted for both complex and non-complex
products on a case-by-case basis and that these meetings are intended
to expedite development, but that they will not necessarily take place
on an expedited basis. We also updated terminology to further delineate
180-day patent exclusivity from 180-day CGT exclusivity. Finally,
editorial changes were made to clarify the operation of 180-day CGT
exclusivity and forfeiture.
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 ``Competitive Generic Therapies.'' 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 previously approved 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-
3521). The collections of information in 21 CFR 314.94, including the
submission of ANDAs and requests for CGT designation, have been
approved under OMB control number 0910-0001 (including 0910-0338 for
Form FDA 356h). The collections of information associated with product
development meetings, presubmission meetings, and mid-review cycle
meetings between applicants and FDA have been approved under OMB
control number 0910-0797.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
Dated: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05293 Filed 3-13-20; 8:45 am]
BILLING CODE 4164-01-P