[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40072-40073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16529]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0603]
Assessment of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications and
Original Biologics License Applications in Prescription Drug User Fee
Act V; 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) is announcing an
opportunity for public comment on the statement of work for an
assessment of the Program for Enhanced Review Transparency and
Communication for New Molecular Entity (NME) New Drug Applications
(NDAs) and Original Biologics License Applications (BLAs) (the
Program). The Program is part of the FDA performance commitments under
the proposed fifth authorization of the Prescription Drug User Fee Act
(PDUFA), which, if enacted into law, will allow FDA to collect user
fees for the review of human drug and biologics applications for fiscal
years (FYs) 2013-2017. The Program is described in detail in section
II.B of the document entitled ``PDUFA Reauthorization Performance Goals
and Procedures Fiscal Years 2013 through 2017.'' \1\ The Program will
be evaluated by an independent contractor in an interim and final
assessment. As part of the FDA performance commitment, FDA is providing
a period of 30 days for public comment on the statement of work before
letting the contract for the assessment.
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\1\ The ``PDUFA Reauthorization Performance Goals and Procedures
Fiscal Years 2013 through 2017'' is available on the Internet at
http://www.fda.gov/downloads/For Industry/UserFees/
PrescriptionDrugUserFee/UCM270412.pdf.
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DATES: Submit electronic or written comments by August 6, 2012.
ADDRESSES: Submit electronic comments to http://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: Andrea Tan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 1173, Silver Spring, MD 20993-0002, 301-796-7641,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The timely review of the safety and effectiveness of new drugs and
biologics is central to FDA's mission to protect and promote the public
health. Before the enactment of PDUFA in 1992, FDA's drug review
process was relatively slow and not very predictable compared to other
countries. As a result of concerns expressed by industry, patients, and
other stakeholders at the time, Congress enacted PDUFA, which provided
the added funds through user fees that enabled FDA to hire additional
reviewers and support staff and upgrade its information technology
systems. In return for these additional resources, FDA agreed to
certain review performance goals, such as completing reviews of NDAs
and BLAs and taking regulatory actions on them in predictable
timeframes. These changes revolutionized the drug approval process in
the United States and enabled FDA to speed the application review
process for new drugs and biologics without compromising the Agency's
high standards for demonstration of safety, efficacy, and quality of
new drugs and biologics prior to approval.
PDUFA provides FDA with a source of stable, consistent funding that
has made possible our efforts to focus on
[[Page 40073]]
promoting innovative therapies and helping to bring to market critical
products for patients. When PDUFA was originally authorized in 1992, it
had a 5-year term. The PDUFA program has been reauthorized every 5
years, with the most recent reauthorization occurring in 2007 for FYs
2008-2012. As directed by Congress in preparing for reauthorization of
PDUFA for a new 5-year period, FDA conducted negotiations with
regulated industry and conducted regular consultations with public
stakeholders, including patient advocates, consumer advocates, and
health care professionals between July 2010 and May 2011. Following
these discussions, related public meetings, and Agency requests for
public comment, FDA transmitted proposed PDUFA V recommendations to
Congress for FYs 2013-2017 on January 13, 2012. If enacted into law,
FDA's proposed PDUFA V recommendations will include an FDA commitment
to implement a new review program for NME NDAs and original BLAs to
enhance review transparency and communication between FDA and
applicants on these complex applications.
II. PDUFA V NME NDA and Original BLA Review Program
FDA's existing review performance goals for priority and standard
applications, 6 and 10 months respectively, were established more than
15 years ago. Since that time, additional requirements in the drug
review process and scientific advances in drug development have made
those goals increasingly challenging to meet, particularly for more
complex applications like NME NDAs and original BLAs that generally are
discussed in an FDA advisory committee meeting. FDA further recognizes
that increasing communication between the Agency and applicants during
FDA's review has the potential to increase efficiency in the review
process.
To promote greater transparency and improve communication between
the FDA review team and the applicant, FDA has proposed a new review
model for NME NDAs and original BLAs in PDUFA V. The Program provides
opportunities for increased communication by building in mid-cycle
communications and late-cycle meetings between FDA and applicants. To
accommodate this increased interaction during regulatory review and to
address the need for additional time to review these complex
applications, FDA's review clock will begin after the 60-day
administrative filing review period for applications reviewed under the
Program. The Program will apply to all NME NDAs and original BLAs
received from October 1, 2012, through September 30, 2017. The goal of
the Program is to improve the efficiency and effectiveness of the
first-cycle review process by increasing communication with sponsors
before application submission to improve the quality and completeness
of submissions, and by increasing communications during application
review. This will provide sponsors with opportunities to clarify
previous submissions and provide additional data and analyses that are
readily available, potentially avoiding the need for an additional
review cycle when FDA's concerns about an application can be promptly
resolved, but without compromising FDA's traditional high standards for
approval. An efficient and effective review process that allows for
timely responses to FDA questions can help ensure timely patient access
to safe, effective, and high quality new drugs and biologics. To
understand the Program's effect on the review of these applications,
interim and final assessments by an independent contractor are key
components of the Program. The performance commitments state that the
statement of work for this effort will be published for public comment
before beginning the assessment (section II.B). Because the assessment
needs to commence at the beginning of PDUFA V on October 1, 2012, if
the program is reauthorized, FDA must publish the statement of work for
public comment in advance of that reauthorization to be able to begin
the assessment on October 1, 2012. Accordingly, FDA is seeking public
comment now on the proposed statement of work for the assessment of the
Program, available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm304793.pdf.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16529 Filed 7-5-12; 8:45 am]
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