[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63896-63898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26854]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4750]
Interpretation of the ``Deemed To Be a License'' Provision of the
Biologics Price Competition and Innovation Act of 2009; 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 final guidance for industry entitled
``Interpretation of the `Deemed To Be a License' Provision of the
Biologics Price Competition and Innovation Act of 2009.'' This guidance
describes FDA's interpretation of the statutory provision under which
an application for a biological product approved under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be
deemed to be a license for the biological product under the Public
Health Service Act (PHS Act) on March 23, 2020. Specifically, this
guidance describes FDA's interpretation of the ``deemed to be a
license'' provision of the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act) for biological products that are approved under
the FD&C Act as of March 23, 2020. This guidance also provides
recommendations to sponsors of proposed protein products intended for
submission in an application that may not receive final approval under
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation of the transition
provision of the BPCI Act.
DATES: The announcement of the guidance is published in the Federal
Register on December 12, 2018.
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-2015-D-4750 for ``Interpretation of the `Deemed To Be a License'
Provision of the Biologics Price Competition and Innovation Act of
2009; Guidance for Industry; Availability.'' 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
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``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; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-
796-3475; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Interpretation of the `Deemed To Be a License' Provision of
the Biologics Price Competition and Innovation Act of 2009.''
This guidance describes FDA's interpretation of the provision of
the BPCI Act under which an application for a biological product
approved under section 505 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a
license for the biological product under section 351 of the PHS Act (42
U.S.C. 262) on March 23, 2020. Specifically, this guidance describes
FDA's interpretation of the ``deemed to be a license'' provision in
section 7002(e) of the BPCI Act for biological products that are
approved under section 505 of the FD&C Act as of March 23, 2020 (the
transition date). This guidance also provides recommendations to
sponsors of proposed protein products intended for submission in an
application that may not receive final approval under section 505 of
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation of section 7002(e)
of the BPCI Act.
Although the majority of therapeutic biological products have been
licensed under section 351 of the PHS Act, some protein products
historically have been approved under section 505 of the FD&C Act. On
March 23, 2010, the BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act
clarified the statutory authority under which certain protein products
will be regulated by amending the definition of a ``biological
product'' in section 351(i) of the PHS Act to include a ``protein
(except any chemically synthesized polypeptide),'' and describing
procedures for submission of a marketing application for a ``biological
product.'' FDA previously stated its interpretation of the statutory
terms ``protein'' and ``chemically synthesized polypeptide'' in the
amended definition of ``biological product'' (see FDA's draft guidance
for industry entitled ``New and Revised Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 2),'' available on FDA's website
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). Elsewhere in this issue of the Federal
Register, FDA also has issued a proposed rule to amend its regulation
that defines ``biological product'' to incorporate changes made by the
BPCI Act, and to provide its interpretation of the statutory terms
``protein'' and ``chemically synthesized polypeptide.'' When final,
this regulation will codify FDA's interpretation of these terms.
The BPCI Act requires that a marketing application for a
``biological product'' (that previously could have been submitted under
section 505 of the FD&C Act) must be submitted under section 351 of the
PHS Act; this requirement is subject to certain exceptions during a 10-
year transition period ending on March 23, 2020 (see section
7002(e)(1)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, an
approved application for a biological product under section 505 of the
FD&C Act shall be deemed to be a license for the biological product
under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI
Act). Among other things, while section 7002(e)(4) of the BPCI Act
explicitly provides that an approved application under section 505 of
the FD&C Act shall be deemed to be a license on March 23, 2020, the
statute does not provide a means for deeming an approved new drug
application (NDA) to be an approved biologics license application (BLA)
prior to, or after, the transition date. Therefore, FDA interprets
section 7002(e) of the BPCI Act to plainly mean that, on March 23,
2020, only approved NDAs will be deemed to be BLAs. After March 23,
2020, the Agency will not approve any application submitted under
section 505 of the FD&C Act for a biological product subject to the
transition provision that is pending or tentatively approved. Such an
application may, for example, be withdrawn and submitted under section
351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance,
FDA provides recommendations to minimize the impact on development
programs for any proposed biological products intended for submission
under section 505 of the FD&C Act that may not be able to receive final
approval by March 23, 2020.
In the Federal Register of March 14, 2016 (81 FR 13373), FDA
announced the availability of the draft of this guidance. FDA received
several comments on the draft guidance, and those comments were
considered as the guidance was finalized. This final guidance explains
that FDA interprets section 7002(e) of the BPCI Act and section 351 of
the PHS Act to mean that an approved NDA for a biological product that
will be deemed to be ``licensed'' under section 351(a) of the PHS Act
on March 23, 2020, can be a reference product for a proposed biosimilar
product or a proposed interchangeable product (see section 351(i)(4) of
the PHS Act). However, a biological product that was first approved in
an NDA under section 505 of the FD&C Act and deemed ``licensed'' under
section 351(a) of the PHS Act on March 23, 2020, will not have been
``first licensed under subsection (a)'' for purposes of section
351(k)(7) of the PHS Act. Thus, such a biological product will not be
eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS
Act. Moreover, FDA interprets the limitations on eligibility for
reference product exclusivity in section 351(k)(7)(C) of the PHS Act to
apply to any reference product. The guidance also clarifies the
Agency's approach to supplements submitted to an approved NDA for a
biological product before March 23, 2020, that are pending on the
transition date.
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 ``Interpretation of the `Deemed To Be a
License' Provision of the Biologics Price Competition and Innovation
Act of 2009.'' It does not
[[Page 63898]]
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 guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 in 21 CFR part 312 has been approved under
OMB control number 0910-0014; the collection of information in 21 CFR
part 314 has been approved under OMB control number 0910-0001; the
collection of information in 21 CFR part 601 has been approved under
OMB control number 0910-0338; and the collection of information for
applications submitted under section 351(k) of the PHS Act has been
approved under OMB control number 0910-0719; the collection of
information in FDA's guidance for industry entitled ``Formal Meetings
Between the FDA and Biosimilar Biological Product Sponsors or
Applicants'' has been approved under OMB control number 0910-0802; and
the collection of information in FDA's guidance for industry entitled
``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products'' has been approved under OMB control number 0910-0429.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26854 Filed 12-11-18; 8:45 am]
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