[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Notices]
[Pages 15019-15020]
[FR Doc No: 2013-05471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0196]

Food and Drug Administration Prescription Drug User Fee Act V
Benefit-Risk Plan; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft 5-year plan describing the
Agency's approach to further developing and implementing a structured
framework for benefit-risk assessment in the human drug and biologic
review process and the opportunity for public comment on the draft
plan. This plan is part of FDA's commitments that were made as part of
the fifth authorization of the Prescription Drug User Fee Act (PDUFA
V). FDA has published the draft plan on its Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.

DATES: Submit either electronic or written comments by May 7, 2013.

ADDRESSES: Submit electronic comments to www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 1199, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>or Stephen
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA), (Pub. L. 112-144).
Section 905 of FDASIA amends section 505(d) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by requiring FDA to ``implement a
structured risk-benefit assessment framework in the new drug approval
process to facilitate the balanced consideration of benefits and risks,
a consistent and systematic approach to the discussion and regulatory
decisionmaking, and the communication of the benefits and risks of new
drugs.'' Title I of FDASIA reauthorizes PDUFA and provides FDA with the
user fee resources necessary to maintain an efficient review process
for human drug and biological products. The reauthorization of PDUFA
includes performance goals and procedures for the Agency that represent
FDA's commitments during fiscal years 2013-2017. These commitments are
fully described in the document entitled ``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013 through 2017''
(``PDUFA Goals Document''), available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Section X of the PDUFA Goals Document, titled
``Enhancing Benefit-Risk Assessment in Regulatory Decisionmaking,''
addresses the development of a 5-year plan that describes the Agency's
approach to further develop and implement a structured benefit-risk
framework in its human drug and biologic review process. The
publication and implementation of this plan are intended to fulfill the
requirement in section 905 of FDASIA and the commitments described in
Section X of the PDUFA Goals Document.

II. Draft Plan Describing Structured Approach to Benefit-Risk
Assessment

    Ensuring the safety, effectiveness, and quality of human drugs is a
complicated regulatory task, requiring FDA's consideration of a
multitude of complex factors. FDA's regulatory decision making process
takes into consideration not only the data submitted in a marketing
application, but also a broad set of additional factors, including the
clinical context for the proposed product (such as the nature and
severity of the disease or condition that the proposed product is
intended to treat or prevent and the benefits and risks of other
available therapies for that disease or condition) and any risk
management tools that might be necessary to ensure that the benefits of
the proposed product outweigh its risks.
    FDA believes that implementing a standardized structure for the
analysis of the various benefit and risk considerations that make up a
regulatory decision will help to facilitate balanced and consistent
consideration of the benefit and risk factors during the review process
and to enhance the transparency of regulatory review. FDA therefore has
developed a draft plan describing a benefit-risk assessment framework
that is designed to make explicit the consideration of the various
benefit-risk factors and the role of those factors in the regulatory
decision-making process for human drug and biological product marketing
applications. It is important to note that, as specified in section 905
of FDASIA, this framework does not change the criteria for approval of
a drug or biological product. All new drug applications and biological
license applications must meet the requirements for approval under the
FD&C Act and the Public Health Service Act, respectively.
    By clearly articulating FDA's key considerations in a standard
structure, this framework can serve as an important tool for the
analysis and discussion of the relevant benefit and risk considerations
during the review process. A second and equally important purpose of
the benefit-risk framework is that it can serve as a tool to
communicate the reasoning of FDA's regulatory decisions to the public.
When FDA approves a new drug or biological product, it generally posts
decisional memos on the Agency's Web site. These documents may be
highly technical and may not be easily understandable to a broad
audience with varying backgrounds. The benefit-risk framework aims to
enhance FDA's communication of its decisions by making clear the
important considerations in the Agency's decision-making process, and
how they affected the final regulatory decision, in a clear, succinct
summary.
    With this notice, FDA is announcing the availability of a draft 5-
year plan describing the Agency's approach to further developing and
implementing the benefit-risk framework and the opportunity for the
public to comment on the plan. FDA has published the plan on the
Agency's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. The comment period will remain
open for 60 days following the publication of this notice. After
consideration of public comments, FDA will finalize the plan.
Throughout PDUFA V, the Agency will update the plan as necessary and
post all updates on the FDA's Web site.

    Dated: March 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05471 Filed 3-7-13; 8:45 am]
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