[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

[[Page 12557]]

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