[Federal Register Volume 65, Number 151 (Friday, August 4, 2000)]
[Notices]
[Pages 47993-47995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19301]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1364]


Prescription Drug User Fee Act (PDUFA); 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 its 
intention to hold a public meeting on the Prescription Drug User Fee 
Act (PDUFA). The legislative authority for PDUFA expires at the end of 
September 2002, and without further legislation the fees and resources 
provided under PDUFA will also expire. FDA is now considering what 
features it should advocate in proposing new or amended authorizing 
legislation. Section 903(b) of the Federal Food, Drug, and Cosmetic Act 
encourages FDA to consult with stakeholders, as appropriate, in 
carrying out agency responsibilities. Accordingly, FDA will convene a 
public meeting to hear stakeholder views on this subject. FDA is 
proposing four specific questions, and the agency is interested in 
responses to these questions and any other pertinent information 
stakeholders would like to share.

DATES: The public meeting will be held on September 15, 2000, at 9 a.m. 
Submit written comments by October 31, 2000. Registration to attend the 
meeting must be received by September 8, 2000.

ADDRESSES: The meeting will be held in the Auditorium, U.S. Department 
of Labor, 200 Constitution Ave. NW., Washington, DC (between 3d and C 
St.).
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, e-mail: [email protected], or via the FDA website at 
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. More information about various aspects of PDUFA and 
this public meeting are available on the Internet at: http://www.fda.gov/oc/pdufa2/meeting2000.html.

REGISTRATION AND REQUEST FOR ORAL PRESENTATION: If you wish to make an 
oral presentation during the open public comment period of the meeting, 
you must specify on your registration form or with the registration 
contact person listed below that you wish to make a presentation. You 
must submit along with your registration form: (1) A brief written 
statement of the general nature of the views you wish to present, (2) 
the names and addresses of all persons who will participate in the 
presentation, and (3) an indication of the approximate time that you 
request to make your presentation. Depending on the number of people 
who register to make presentations, FDA may have to limit the time 
allotted for each presentation.
    In order to register, you must submit your name, title, business 
affiliation, address, telephone, fax number (optional), and email 
address (optional).

REGISTRATION CONTACT: All registration materials should be sent to 
Patricia Alexander, Office of Consumer Affairs (HFE-40), Food and Drug 
Administration, Rockville, MD 20857, 301-827-4391, FAX 301-827-2866, e-
mail: [email protected], or on the Internet at http://www.fda.gov/oc/pdufa2/meeting2000.html.
    All registration will be accepted on a first-come, first-served 
basis. Speakers will be chosen in order of registration. All other 
comments should be sent to the FDA docket.
    If you need special accommodations due to a disability, please 
inform the contact person when you register.

FOR FURTHER INFORMATION CONTACT: Virginia Cox, Office of the 
Commissioner (HF-10), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3409, FAX 301-594-6777, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 1992, Congress passed PDUFA. PDUFA authorized FDA to collect 
fees from companies that produce certain human drug and biological 
products. The original PDUFA had a 5-year life; it ended in 1997, the 
same year Congress passed the FDA Modernization Act (FDAMA). Part of 
FDAMA included an extension of PDUFA (PDUFA II) for an additional 5 
years.
    PDUFA's original intent was to provide FDA with additional revenue 
so it could hire more reviewers and support staff and upgrade its 
information technology to speed up the application review process for 
human drug and biological products without compromising review quality. 
The revenues are provided by a set of three fees, with one-third of the 
total annual revenue coming from each of the following fees:
    1. Application fees for the submission of certain human drug or 
biological application (in fiscal year (FY) 2000, $285,740 per 
application with clinical data, and $142,870 per application without 
clinical data or per supplemental application with clinical data);
    2. Annual establishment fees paid for each establishment that 
manufactures prescription drugs or biologicals (in FY 2000, $141,971 
per establishment); and
    3. Annual product fees assessed on certain prescription drug and 
biological products (in FY 2000, $19,959 per product).
    In the aggregate these fees are expected to generate $135 million 
this FY, and increase to about $162 million in FY 2002, the last year 
of PDUFA II. No separate fees are charged for investigational new drug 
applications. However, since the review of investigational new drug 
applications is included in the definition of the process for the 
review of human drug applications, as defined in PDUFA, FDA uses some 
of the application, establishment, and product fees collected for the 
review of investigational new drug applications.
    In consultation with industry and the Congress, FDA agreed to meet 
a set of review performance goals that became more stringent each year 
if FDA also received sufficient fee resources to enable goal 
achievement. These goals applied to the review of original new human 
drug and biological applications, resubmissions of original 
applications, and supplements to approved applications. FDA met every 
PDUFA I performance goal and, to date, has met all but one PDUFA II 
performance goal. Industry also insisted on a statutory provision that 
fees could only be collected and spent each year if a large, inflation-
adjusted portion of drug review costs would continue to be funded from 
appropriations rather than fees, so that the fees were funding 
additional drug review resources rather than replacing appropriations.
    Under PDUFA II, the review goals continue to shorten. By 2002, the 
PDUFA II goals call for FDA to review and act on 90 percent of:
    1. Standard new drug and biological product applications and 
efficacy supplements within 10 months;
    2. Priority new drug and biological product applications and 
efficacy supplements (i.e., for products providing significant 
therapeutic gains) within 6 months;
    3. Manufacturing supplements within 6 months, and those requiring 
prior approval within 4 months;
    4. Class 1 resubmissions within 2 months, and Class 2 resubmissions 
within 6 months.
    In addition, PDUFA II added a new set of procedural goals intended 
to

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improve FDA's responsiveness to, and communication with, industry 
sponsors during the early years of drug development. These goals 
specify timeframes for activities such as scheduling meetings and 
responding to various sponsor requests. While PDUFA's original intent 
was to speed up the review process, PDUFA II's intent is to speed up 
the entire drug development process.
    PDUFA has had a dramatic and undeniable impact on the drug review 
process. Total resources for drug review activities have increased from 
$120 million in 1992, before PDUFA was enacted, to an estimated $325 
million in FY 2002, about half of which will come from fees paid by 
industry. These resources allowed FDA to increase its drug and 
biological review staff by almost 60 percent between 1993 and 1997, 
adding about 660 staff-years to the program by 1997. By the end of 
PDUFA II in 2002, FDA expects to have added another 313 staff-years of 
effort to this program. These additional staff, and resources to 
support them, have enabled FDA to respond more rapidly to new drug and 
biologic applications without compromising review quality.
    While it is important to note that PDUFA's goals specify decision 
times, not approval times, both decision and approval times have 
decreased dramatically. Total approval time, the time from the initial 
submission of a marketing application to the issuance of an approval 
letter, has dropped from a pre-PDUFA median of 23 months to 12 months. 
Total approval time for priority applications, those for products 
providing significant therapeutic gains, has dropped from a median of 
over 12 months in the early PDUFA years to 6 months. In addition, 
because FDA has put greater effort into communicating what it expects 
applicants to submit, a higher percentage of applications are being 
approved. Before PDUFA, only about 60 percent of the applications 
submitted were ultimately approved. Now, about 80 percent are approved. 
For the consumer, this has meant more products available more quickly.
    The agency has also encountered some challenges with PDUFA. 
Assuring that enough appropriated funds are spent on the process for 
the review of human drug applications to meet requirements of PDUFA, 
and at the same time spending our resources in a way that best protects 
the health and safety of the American people is becoming increasingly 
difficult. Each year, the amount that FDA must spend from 
appropriations on the drug review process is increased by an inflation 
factor. Yet, since 1992 FDA has not received increased appropriations 
to cover the costs of the across-the-board pay increases that must be 
given to all employees.
    The result is that our workforce and real resources for most 
programs other than PDUFA have contracted each year since 1992 while we 
struggle to ensure that enough funds are spent on the drug review 
process to meet this PDUFA requirement. Several consecutive years of 
operating in this way have made it difficult to continue to further 
reduce staffing levels in FDA programs other than drug review. We are 
increasingly concerned that spending enough appropriations on the drug 
review process to meet the statutory conditions makes FDA less able to 
manage the resources available in a way that best protects the public 
health and merits public confidence. Just one example of an area we 
have not been able to fund adequately is responding to reports of 
adverse events related to the use of prescription drugs.

II. Scope of Discussion

    The legislative authority for PDUFA II expires at the end of 
September 2002, and without further legislation the fees and resources 
they have provided will also expire. FDA is now considering what 
characteristics and conditions it should advocate in proposing new or 
amended authorizing legislation. Section 903(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(b)) encourages FDA to consult 
with stakeholders, as appropriate, in carrying out agency 
responsibilities. Accordingly, FDA will convene a public meeting on 
September 15, 2000. Interested persons are invited to attend and 
present their views.
    A list of questions that we are asking interested parties to 
address at this meeting follows:
    1. Since 1993 FDA has been receiving fees for the review of certain 
human drug and biological products. As a result, FDA has implemented 
management improvements that have substantially decreased the time for 
new drug review and made new medications available to the public 
faster. Do you view this as a benefit of the user fee program that 
should be maintained in the future? What are some of the other benefits 
that you think are important? How do you think the program can be 
strengthened? In addition, what do you see as the downside of a 
regulatory agency like FDA collecting user fees and what remedies would 
you propose for the future?
    2. Should we continue to have performance goals for the drug and 
biological review process? If so, how should goals be determined?
    3. If user fees fund FDA's drug and biological review processes, 
what percentage of the program's costs should be covered by fees, and 
how should those fees be used? The following table shows the percent of 
drug and biological review spending funded by industry fees since the 
beginning of PDUFA in 1993:

                                                                        Table 1.
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       Year                1993                1994               1995               1996               1997               1998               1999
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Fee percent         7%                  24%                36%                36%                36%                40%                43%
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    The percent paid from fee revenues is currently estimated to exceed 
50 percent of FDA's spending on drug review by 2002.
    The following table shows the approximate percent of costs of 
overall drug regulation paid from industry fees in some other 
countries:

                                Table 2.
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     Country           Australia           Canada        United Kingdom
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Fee percent        100%               70%               100%
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    4. Should fees collected from industry be used to pay for other 
costs FDA incurs to ensure that drugs in the American marketplace are 
safe and effective? Such additional costs might include monitoring 
adverse drug reactions, monitoring drug advertising, and routine 
surveillance, inspection and testing of drug manufacturers.

III. Comments

    Interested persons may submit written comments to the Dockets 
Management Branch (address above), or via e-mail to 
[email protected], or via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/commentsdocket.cfm. by 
October 31, 2000. Comments are to be identified with the docket number 
found in brackets in the heading of this document. You may review 
received comments in the Dockets Management Branch between 9 a.m. and 4 
p.m., Monday through Friday.

IV. Transcripts

    You may request a transcript of the PDUFA public meeting in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 10 cents per page. You may also examine the transcript of 
the meeting after September 30, 2000, at the Dockets Management Branch 
between 9 a.m. and 4 pm., Monday through Friday, as well as on the 
Internet at http://www.fda.gov/oc/pdufa2/meeting2000.html.

    Dated: July 25, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-19301 Filed 8-3-00; 8:45 am]
BILLING CODE 4160-01-F