[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4826-4828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02598]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0065]
Competitive Generic Therapies; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Competitive Generic Therapies.'' On August 18, 2017, the FDA
Reauthorization Act of 2017 (FDARA), which amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a
section was added to the FD&C Act that established a new process to
designate, and expedite the development and review of, certain drugs
intended for submission or submitted in an abbreviated new drug
application (ANDA) and for which there is ``inadequate generic
competition.'' This draft guidance provides a description of the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. This draft guidance also includes information on the
actions FDA may take to expedite the development and review of an ANDA
for a drug designated as a CGT. This draft guidance also provides
information on how FDA implements the statutory provisions providing
for a 180-day exclusivity period for certain first approved applicants
that submit ANDAs for drugs designated as CGTs.
DATES: Submit either electronic or written comments on the draft
guidance by April 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
[[Page 4827]]
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.gpo.gov/fdsys/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 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Competitive Generic Therapies.'' On August 18, 2017, FDARA
(Pub. L. 115-52) was signed into law. As part of FDARA, the Generic
Drug User Fee Amendments were reauthorized (Title III) to continue
timely access to high-quality affordable generic medicines. FDARA also
created other enhancements associated with generic drugs. Specifically,
section 803 of FDARA amended the FD&C 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 intended for
submission or submitted in an ANDA and 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. 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 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. This guidance also includes
information on the actions FDA may take to expedite the development and
review of ANDAs for drugs designated as CGT. These actions may help to
clarify the regulatory expectations for a particular drug, assist
applicants in developing a more complete submission, and ultimately
promote a more efficient and effective ANDA review process and help
reduce the number of review cycles necessary to obtain ANDA approval.
This guidance also provides information on how FDA implements the
statutory provisions providing for a 180-day exclusivity period for
certain first approved applicants that submit ANDAs for 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 patent or exclusivity and for which there is
inadequate generic competition.
This draft guidance is being issued consistent with FDA's good
guidance
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practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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. This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft 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-
3520). The collections of information in 21 CFR 314.94, including the
submission of ANDAs and designations such as CGT product development,
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 draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02598 Filed 2-15-19; 8:45 am]
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