[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12555-12557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5664]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0128]
Prescription Drug User Fee Act; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting on the Prescription Drug User Fee Act (PDUFA). The legislative
authority for PDUFA expires in September 2012. At that time, new
legislation will be required for FDA to continue collecting user fees
for the prescription drug program. The Federal Food, Drug, and Cosmetic
Act (FD&C Act) requires that before FDA begins negotiations with the
regulated industry on PDUFA reauthorization, we publish a notice in the
Federal Register requesting public input on the reauthorization, hold a
public meeting at which the public may present its views on the
reauthorization, provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes, and
publish the comments on FDA's Web site. FDA invites public comment on
the PDUFA program and suggestions regarding the features FDA should
propose for the next PDUFA program.
DATES: The public meeting will be held on April 12, 2010, from 9 a.m.
to 5 p.m. Registration to attend the meeting must be received by April
5, 2010. See Section III.C of this document for information on how to
register for the meeting. Submit written or electronic comments by May
12, 2010.
ADDRESSES: The meeting will be held at the Hilton Washington DC/
Rockville Hotel and Executive Meeting Center, 1750 Rockville Pike,
Rockville, MD 20852.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061.
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document.
Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the meeting.
FOR FURTHER INFORMATION CONTACT: Mary Gross, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, rm. 6178, Silver Spring, MD 20993, 301-796-
3519, FAX: 301-847-8753, [email protected]; or
Patrick Frey, Food and Drug Administration, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6350,
Silver Spring, MD 20993, 301-796-3844, FAX: 301-847-8443,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing its intention to hold a public meeting on PDUFA.
The authority for PDUFA expires in September 2012. Without new
legislation, FDA will no longer be able to collect user fees to fund
the human drug review process. Section 736B(d)(2) (21 U.S.C. 379h-
2(d)(2)) of the FD&C Act requires that before FDA begins negotiations
with the regulated industry on PDUFA reauthorization, we do the
following: (1) Publish a notice in the Federal Register requesting
public input on the reauthorization, (2) hold a public meeting at which
the public may present its views on the reauthorization, (3) provide a
period of 30 days after the public meeting to obtain written comments
from the public suggesting changes, and (4) publish the comments on the
FDA Web site. This notice, the public meeting, the 30 day comment
period after the meeting, and the posting of the comments on the FDA
Web site will satisfy these requirements. The purpose of the meeting is
to hear stakeholder views on PDUFA as we consider the features to
propose in the next PDUFA program. FDA is interested in responses to
the following two general questions and welcomes any other pertinent
information stakeholders would like to share:
1. What is your assessment of the overall performance of the PDUFA
IV program thus far?
2. What aspects of PDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
The following information is provided to help potential meeting
participants better understand the history and evolution of the PDUFA
program and its current status.
II. What is PDUFA? What Does It Do?
PDUFA is a law that authorizes FDA to collect fees from drug
companies that submit marketing applications for certain human drug and
biological products. The original PDUFA (PDUFA I) was enacted in 1992
(as the Prescription Drug User Fee Act, Public Law 102-571) and had a
5-year life. In 1997, as PDUFA I expired, Congress passed the FDA
Modernization Act (FDAMA, Public Law 105-115) which included an
extension of PDUFA (PDUFA II) for an additional 5 years. In 2002,
Congress extended PDUFA again through fiscal year 2007 (PDUFA III)
through the Public Health Security and Bioterrorism Preparedness and
Response Act (Public Law 107-188). Most recently, Title I of the Food
and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-
85) reauthorized PDUFA through fiscal year 2012 (PDUFA IV).
PDUFA's intent has been to provide additional revenues so that FDA
could hire more staff, improve systems, and establish a better managed
human drug review process to make important therapies available to
patients sooner without compromising review quality or approval
standards. In conjunction with PDUFA, FDA agrees to certain performance
goals. These goals apply to
[[Page 12556]]
the process for the review of original new human drug and biological
product applications, resubmissions of original applications, and
supplements to approved applications. During the first few years of
PDUFA I, the additional funding enabled FDA to eliminate backlogs of
original applications and supplements. Phased in over the 5 years of
PDUFA I, the goals were to review and act on 90 percent of priority new
drug applications (NDAs), biologics license applications (BLAs), and
efficacy supplements within 6 months of submission of a complete
application; to review and act on 90 percent of nonpriority original
NDAs, BLAs, and efficacy supplements within 12 months; and on
resubmissions and manufacturing supplements within 6 months. Over the
course of PDUFA I, FDA exceeded all of these performance goals and
significantly reduced median review times of both priority and standard
NDAs and BLAs.
Under PDUFA II, many of these review performance goals were
shortened and new procedural goals were added to improve FDA
interactions with industry sponsors and help facilitate the drug
development process. The procedural goals, for example, articulated
timeframes for scheduling sponsor-requested meetings intended to
address emerging drug development challenges, as well as timeframes for
the timely response to industry submitted questions on special study
protocols. FDA met or exceeded nearly all of the review and procedural
goals under PDUFA II. However, concerns grew that overworked review
teams often had to return applications as ``approvable'' as they did
not have the resources and sufficient staff time to work with the
sponsors to resolve issues so that applications could reach approval in
the first review cycle.
A sound financial footing and support for limited postmarket risk
management were key themes of PDUFA III. Base user fee resources were
significantly increased and a mechanism to account for changes in human
drug review workload was adopted. PDUFA III also expanded the scope of
user fee activities to include postmarket surveillance of new therapies
for up to 3 years after marketing approval. FDA committed to the
development of guidance for industry on risk assessment, risk
management, and pharmacovigilance as well as guidance to review staff
and industry on Good Review Management Principles (GRMPs). Initiatives
to improve application submission and agency-sponsor interactions
during the drug development and application review processes were also
adopted.
With PDUFA reauthorization under FDAAA Title I (PDUFA IV), FDA
obtained a significant increase in base fee funding and committed to
full implementation of GRMPs, which includes providing a planned review
timeline for premarket review, development of new guidance for industry
on innovative clinical trials, modernization of postmarket safety, and
elimination of the 3-year limitation on fee support for postmarket
surveillance. However, the passage of FDAAA Titles IV, V, and IX added
statutory requirements that increased the pre- and postmarket review
process requirements, added new deadlines, and effectively increased
the review workload. For example, these provisions significantly
increased the number of applications requiring advisory committee
review while creating more stringent conflict-of-interest rules for
advisory committee members. The provisions also provided expanded drug
safety authorities such as the authority to require Risk Evaluation
Mitigation Strategies (REMS), order safety labeling changes, and
require postmarket studies and trials. Since enactment of PDUFA IV at
the start of fiscal year 2008, FDA has focused on implementation of the
new statutory requirements, rapidly hiring new staff to increase FDA
review capacity, and the iterative improvement of review processes.
This necessary focus has affected performance on a number of PDUFA
review goals and delayed work on some of the new PDUFA IV initiatives.
FDA has published a number of reports that may provide the public
with useful background on PDUFA IV and FDAAA. Key Federal Register
documents, PDUFA-related guidances, legislation, performance reports,
and financial reports and plans can be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. FDA will also
post a webinar on PDUFA to give the public more background information
on the program. The webinar will be available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm117890.htm
approximately 10 days before the public meeting. FDAAA-specific
information is available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm.
III. What Information Should You Know About the Meeting?
A. When and Where Will the Meeting Occur? What Format Will FDA Use?
Through this notice, we are announcing a public meeting to hear
stakeholder views on what features we should propose in the PDUFA V
program. We will conduct the meeting on April 12, 2010, at the Hilton
Washington DC/Rockville (see ADDRESSES). In general, the meeting format
will include presentations by FDA and a series of panels representing
different stakeholder interest groups (such as patient advocates,
consumer protection, industry, health professionals, and academic
researchers). We will also provide an opportunity for individuals to
make presentations at the meeting and for organizations and individuals
to submit written comments to the docket after the meeting. FDA policy
issues are beyond the scope of these reauthorization discussions.
Accordingly, the presentations should focus on process enhancements and
funding issues, and not focus on policy issues.
B. What Questions Would FDA Like the Public to Consider?
Please consider the following questions for this meeting:
1. What is your assessment of the overall performance of the PDUFA
IV program thus far?
2. What aspects of PDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
C. How Do You Register for the Meeting or Submit Comments?
If you wish to attend and/or present at the meeting, please
register by e-mail to [email protected] by April 5,
2010. Your e-mail should contain complete contact information for each
attendee, including name, title, affiliation, address, e-mail address,
and phone number. Registration is free and will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. We will try to
accommodate all persons who wish to make a presentation. The time
allotted for presentations may depend on the number of persons who wish
to speak. If you need special accommodations because of disability,
please contact
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Mary Gross (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
In addition, any person may submit written or electronic comments
to the Division of Dockets Management (see ADDRESSES). Submit a single
copy of electronic comments or two paper copies of any mailed comments,
except that individuals may submit one paper copy. Comments are to be
identified 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. To ensure
consideration, all comments must be received by May 12, 2010.
D. Will Meeting Transcripts Be Available?
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov and http://www.fda.gov. It may be viewed at the Division of Dockets Management
(see ADDRESSES). A transcript will also be available in either hard
copy or on CD-ROM, after submission of a Freedom of Information
request. Written requests are to be sent to Division of Freedom of
Information (HFI-35), Office of Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.
Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5664 Filed 3-15-10; 8:45 am]
BILLING CODE 4160-01-S