[Federal Register: October 18, 2005 (Volume 70, Number 200)]
[Page 60536-60538]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0410]

Prescription Drug User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


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 2007. Without further 
legislation, we will no longer be able to collect user fees for the 
prescription drug program and resources critical to running the program 
would become unavailable to us. We invite public comment on the PDUFA 
program and suggestions regarding what features we should propose for 
the next PDUFA program.

DATES: The public meeting will be held on November 14, 2005, from 9 
a.m. to 5 p.m. Registration to attend the meeting must be received by 
October 31, 2005. You may register electronically at 
CBERTraningSuggestions@cber.fda.gov. Walk-in registration at the 

meeting site will also be accepted. Submit written comments by December 
14, 2005.

ADDRESSES: The meeting will be held at the Natcher Conference Center, 
National Institutes of Health, Bldg. 45, Center Dr., 9000 Rockville 
Pike, Bethesda, MD 20815. Parking is limited, and there may be delays 
entering the NIH campus due to increased security. All visitors' 
vehicles will be inspected, and visitors must show one form of 
identification (ID) (such as a government-issued photo ID, driver's 
license, passport, etc.) We recommend arriving by subway (Metrorail) if 
possible. NIH is accessible from the Metrorail's ``Red Line'' at the 
Medical Center/NIH station.
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments

    For information regarding this notice: Patricia A. Stewart, Office 
of Policy and Planning (HFP-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2647, FAX: 301-594-6777, e-
mail: Patricia.Stewart@oc.fda.gov.
    For information regarding registration: Melanie Whelan or Kathy 
Eberhart, Office of Communication, Training and Manufacturers 
Assistance (HFM-49), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-2000, FAX: 


I. Introduction

    FDA is announcing its intention to hold a public meeting on PDUFA. 
The authority for PDUFA expires in September 2007. Without further 
legislation, FDA would no longer be able to collect user fees for the 
prescription drug program. Resources critical to running the program 
would become unavailable to FDA. We are now considering what features 
we should propose for the next PDUFA program. We are convening a public 
meeting to hear stakeholder views on this subject. We are offering the 
following two general questions for consideration, and we are 
interested in responses to these questions and any other pertinent 
information stakeholders would like to share:
    1. What is your assessment of the overall performance of the PDUFA 
program thus far?
    2. What aspects of PDUFA should be retained, or what should be 
changed to further strengthen and improve the program?
    We provide the following background on the PDUFA program so 
potential participants can better understand the history and evolution 
of the PDFUA program and its current status.

II. What is PDUFA? What Does It Do?

    PDUFA, in broad terms, is a series of laws that have authorized us 
to collect fees from companies that produce 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). FDAMA included, among 
other things, an extension of PDUFA (PDUFA II) for an additional 5 
years. In 2002, Congress extended PDUFA again for 5 years (PDUFA III) 
through the Public Health Security and Bioterrorism Preparedness and 
Response Act (Public Law 107-188).
    PDUFA's original intent was to provide additional revenues to us so 
that we could hire more staff to improve the process for the review of 

[[Page 60537]]

drugs to make important drug therapies available to patients sooner 
without compromising review quality.
    Under PDUFA, the industry provided additional funds through user 
fees that would be available to FDA, in addition to appropriated funds, 
to spend on the process for the review of human drugs. Our authority to 
collect user fees is ``triggered'' only when a base amount of 
appropriated funds, adjusted for inflation, is spent.
    In conjunction with PDUFA, we set review performance goals that 
became more stringent each year. These goals applied to 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, we eliminated 
backlogs of original applications and supplements that had formed in 
earlier years when the program had fewer resources. 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 (i.e., submissions for products 
providing significant therapeutic gains) 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, we exceeded all of these 
performance goals.
    Under PDUFA II, some review performance goals continued to shorten. 
For example, by 2002, the PDUFA II goals called on us to review and act 
on 90 percent of the following:
     Standard new drug and biological product applications and 
efficacy supplements within 10 months;
     Chemistry and Manufacturing Control supplements requiring 
prior FDA approval within 4 months; and
     Class 1 resubmissions (that respond to relatively minor 
deficiencies such as labeling changes) within 2 months.
    In addition, PDUFA II added a new set of procedural goals intended 
to improve our interactions with industry sponsors during the early 
years of drug development. For example, these goals called for us to 
meet with sponsors and provide followup meeting minutes within a 
certain number of days, and provide responses to questions on industry 
submitted special study protocols within a certain number of days.
    We met or exceeded nearly all of our goals for application review 
and for these other procedures under PDUFA II.
    Under PDUFA III, additional money from user fees was authorized, 
and a mechanism placed in the act to annually account for increases in 
workload associated with the process for the review of human drugs. For 
the first time, PDUFA III also authorized us to spend user fee funds on 
certain aspects of postmarket risk management. The review performance 
and procedural goals associated with PDUFA III were similar to those 
under PDUFA II for fiscal year (FY) 2002 performance levels, but the 
PDUFA III program addressed drug safety issues and established several 
new initiatives to improve application submissions and agency-sponsor 
interactions during drug development and application review.
    The goals under PDUFA III also included new provisions, for 
example, to develop guidance for industry on good risk assessment, risk 
management, and pharmacovigilance practices, to fund outside expert 
consultants to help evaluate and improve review management processes, 
and to centralize accountability and funding for all PDUFA information 
technology initiatives and activities.
    Furthermore, in conjunction with PDUFA's reauthorization in 2002, 
we committed to the creation of a guidance for our review staff and 
industry on good review management principles and practices as they 
apply to the first cycle review of NDAs, BLAs, and efficacy 
supplements, and we announced the guidance's availability in the 
Federal Register of March 31, 2005 (70 FR 16507). We also set a goal of 
testing whether providing early review of selected applications and 
additional feedback and advice to sponsors during drug development for 
selected products can shorten drug development and review times. There 
were two continuous marketing application (CMA) pilot programs; CMA 
Pilot 1 provides for the review of a limited number of presubmitted 
portions of NDAs and BLAs. Under CMA Pilot 2, FDA and applicants can 
enter into agreements to engage in frequent scientific feedback and 
interactions during the investigational new drug phase of product 
development. The first-cycle and CMA initiatives are currently being 
evaluated to determine their impact on the effectiveness and efficiency 
of FDA-sponsor communications, product development, and regulatory 
    We have published a number of reports that may help inform the 
public about PDUFA and its implementation. Key Federal Register 
documents, such as, PDUFA-related guidances, legislation, performance 
reports, and financial reports, can be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa/
 and www.fda.gov/cder/pdufa. We may make additional information 

about PDUFA available on our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa. 

Additional information about the activities of the involved FDA product 
centers can be found in the Center for Drug Evaluation and Research 
2004 Report to the Nation (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/reports/rtn/2004/rtn2004.htm
), and the Center for Biologics Evaluation and Research FY 

2004 Annual Report (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/inside/annrpt.htm).

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will We Use?

    Through this notice, we are announcing that we will convene a 
public meeting to hear stakeholder views on what features we should 
advance in proposing the PDUFA IV program.
    We will conduct the meeting on November 14, 2005, at the Natcher 
Conference Center, National Institutes of Health (NIH) (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

B. What Questions Would We 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 
program thus far?
    2. What aspects of PDUFA should be retained, or what should be 
changed 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 make a presentation at the meeting, 
please send an e-mail message to: CBERTrainingSuggestions@cber.fda.gov 
by October 31, 2005. Your e-mail should include the following 
information: Name, company, company address, company phone number, and 
e-mail address. You will receive a confirmation within 2 business days.
    We also will accept walk-in registration at the meeting site, but

[[Page 60538]]

space is limited, and we will close registration when maximum seating 
capacity (approximately 500) is reached.
    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 require special accommodations due to a disability, please 
contact Patricia A. Stewart at least 7 days in advance.
    If you would like to submit comments regarding PDUFA IV, please 
send your comments to the Division of Dockets Management (see 
ADDRESSES). Submit a single copy of electronic comments or two paper 
copies of any written 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.

D. Will Meeting Transcripts Be Available?

    We will prepare a meeting transcript, and we will make the 
transcript available on our Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov) after the 

meeting. We anticipate that transcripts will be available approximately 
30 working days after the meeting. The transcript will also be 
available for public examination at the Division of Dockets Management 
(see ADDRESSES), between 9 a.m. and 4 p.m. Monday through Friday.

    Dated: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20875 Filed 10-14-05; 8:57 am]