[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Pages 76738-76740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31630]



Food and Drug Administration

[Docket No. FDA-2010-N-0381]

Generic Drug User Fee; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


    The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss proposed recommendations for enactment of a Generic 
Drug User Fee Act (GDUFA), which will authorize FDA to collect fees and 
use them for the process for the review of human generic drug 
applications and associated Type II Active Pharmaceutical Ingredient 
Drug Master Files (DMFs) and for conducting associated inspections for 
fiscal years (FYs) 2013-2017. New legislation would be required for FDA 
to establish and collect user fees under such a program. FDA and the 
regulated industry have developed a proposal for Congressional 
consideration. In the interest of transparency, and in an effort to 
voluntarily follow a process similar to the ones set forth in the 
Federal Food, Drug, and Cosmetic Act for FDA's other user fee programs, 
FDA is publishing the negotiated recommendations (the goals letter), 
holding a meeting at which the public may present its views on such 
recommendations, and providing an opportunity for the public to provide 
written comments on such recommendations.
    Date and Time: The public meeting will be held on December 19, 
2011, from 10 a.m. to 5 p.m. Registration to attend the meeting must be 
received by December 12, 2011. The meeting will also be Web cast. See 
Section III. B. of this document for information on how to register for 
the meeting and Section III.C. on information about how to access the 
Web cast. Please submit any comments that you plan to present at the 
public meeting to the docket by the date of the public meeting but note 
that written or electronic comments must be submitted by January 6, 

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 2, rm. 2047, Silver Spring, MD 20993. 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

[[Page 76739]]

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.fda.gov and http://www.regulations.gov as soon as they are 
prepared after the public meeting (see Section III.C. of this 

FOR FURTHER INFORMATION CONTACT: Mari Long, Office of Policy, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4237, 
Silver Spring, MD 20993, (301) 796-7574, FAX: 301 847-3541, 
[email protected]; or Peter C. Beckerman, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4238, 
Silver Spring, MD 20993, (301) 796-4830, FAX: (301) 847-3541, 
[email protected].


I. Background

    FDA is announcing its intention to hold a public meeting to discuss 
proposed recommendations for the enactment of a GDUFA that would 
authorize FDA to collect user fees related to human generic drugs and 
use them for the process of the review of human generic drug 
applications and associated submissions, to conduct related 
inspections, and to engage in other related activities for FYs 2013 to 
2017. New legislation is required for FDA to establish and collect user 
fees for generic drugs. In furtherance of such a program, FDA engaged 
in negotiations with three industry trade associations over aspects of 
a joint proposal for a generic drug user fee program, including fees 
and performance goals, from February through September 2011. The Agency 
held four prior public meetings on the topic before and during this 
process, posted meeting minutes after each negotiation session as well 
as posting other related materials, held a public docket open during 
the negotiation, and considered all comments that were submitted.
    FDA and industry were able to reach agreement on a GDUFA program 
that, if enacted, is expected to place FDA's generic drug program on a 
sound financial footing and would further the fundamental interests of 
safety, access, and transparency. The GDUFA proposal that resulted from 
this process is focused on three key aims:
     Safety: To ensure that industry participants, foreign or 
domestic, who participate in the U.S. generic drug system are held to 
consistent high quality standards and are inspected biennially, using a 
risk-based approach, with foreign and domestic parity.
     Access: To expedite the availability of low-cost, high-
quality generic drugs by bringing greater predictability to the review 
times for abbreviated new drug applications, amendments and 
supplements, increasing predictability, and timeliness in the review 
     Transparency: To enhance FDA's ability to protect 
Americans in the complex global supply environment by requiring the 
identification of facilities involved in the manufacture of generic 
drugs and associated active pharmaceutical ingredients and improving 
FDA's communications and feedback with industry in order to expedite 
product access.
    Generic drugs play a critical role in providing more affordable, 
therapeutically equivalent medicine, and the GDUFA program is designed 
to keep individual fee amounts as low as possible to supplement 
appropriated funding to ensure that consumers continue to receive the 
significant benefits offered by generic drugs. Generic drugs provided 
more than $824 billion dollars in savings to the nation's health care 
system in the last decade alone. The additional resources called for 
under the agreement, an inflation-adjusted $299 million annually for 
each of the 5 years of the program, will provide FDA with the ability 
to perform critical program functions that could not otherwise occur. 
This program is not expected to add significantly to the cost of 
generic drugs: Given that a reported 3.99 billion retail prescriptions 
per year were dispensed in the United States in 2010 and assuming that 
78 percent of these prescriptions were filled by generic drugs, it 
equates to less than a dime per prescription for the average cost of a 
prescription filled by a generic drug in the United States. Moreover, 
with the adoption of user fees and the associated savings in 
development time, the overall expense of bringing a product to market 
may decline and result in reduced costs.
    In addition to the public health benefits, the proposed program is 
expected to provide significant value to companies, and in particular 
to small companies and first time entrants in the generic market, who 
will benefit significantly from the certainty associated with 
performance review metrics that offer the potential to dramatically 
reduce the time needed to commercialize a generic drug when compared to 
pre-GDUFA review times.
    Because FDA remains interested in hearing from nonaffiliated 
companies in addition to patient and consumer stakeholders, the Agency 
is holding this final public meeting prior to providing recommendations 
to Congress. The meeting will provide an explanation of the negotiated 
joint recommendations and provide an opportunity for additional 
stakeholder reaction and input.

II. The Proposed GDUFA Program

A. Recommendations

    Key attributes of the proposed GDUFA Program, as negotiated, are 
memorialized in a goals letter that FDA has posted on its generic drug 
user fee Web page, which is accessible at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm.

B. Summary of the Program

    If enacted as negotiated, the program would provide FDA with 
additional funding for all aspects of the generic drug program in the 
amount of $299 million per year, adjusted for inflation, for 5 years. 
With those additional user fee funds, FDA would agree to undertake a 
series of immediate program enhancements and performance goals. A 
nonexclusive list of major end goals for the program includes:
    1. Application metrics that increase to an eventual year 5 goal of 
FDA reviewing and acting on 90 percent of complete electronic 
abbreviated new drug applications (ANDAs) within 10 months after the 
date of submission;
    2. Backlog metrics of FDA reviewing and acting on 90 percent of all 
ANDAs, ANDA amendments, and ANDA prior approval supplements pending on 
October 1, 2012, by the end of FY 2017; and
    3. Current good manufacturing practice (CGMP) inspection metrics 
under which FDA will conduct risk-adjusted biennial CGMP inspections of 
generic active pharmaceutical ingredient (API) and generic finished 
dosage form (FDF) manufacturers with the goal of achieving parity of 
inspection frequency between foreign and domestic firms in FY 2017.
    Many additional, and interim, performance metrics and efficiency 
enhancements are set forth in the negotiated documents.
    Under the program, fees would derive from two primary sources: 
Generic drug-related submissions and generic drug-related facilities. 
Submission fees would include fees for ANDAs and prior approval 
supplements, as well as for DMFs (for first reference only, as DMFs may 
be referenced multiple times by different sponsors). Facility fees 
would include fees for facilities that manufacture APIs for generic 
drugs as well and facilities that manufacture

[[Page 76740]]

generic FDFs. In the first year of the program, there would also be a 
fee assessed for applications that are pending on October 1, 2012, the 
so-called ``backlog''.
    As under the prescription drug user fee act (PDUFA), individual fee 
amounts would be set annually, with the total annual revenue provided 
by the user fee specified in statute. Of the total generic drug user 
fee revenue, 80 percent would be provided by the FDF manufacturers and 
20 percent by API manufacturers. Additionally, 70 percent of the 
overall GDUFA revenue would be generated by facility fees and 30 
percent would be generated by submission fees; though in the first year 
those splits will be slightly different because of the one-time backlog 
    While it is not possible to provide actual individual fee amounts 
until such fees are set by a Federal Register notice, it is expected 
that individual GDUFA fees will be orders of magnitude less than PDUFA 
fees, a factor due to the larger fee paying base in GDUFA. In 
negotiating the program, FDA was cognizant that generic drugs are a 
tremendous public health success story, responsible for saving $824 
billion over the last decade. Consequently, the Agency worked to 
achieve a program that would not appreciably add to the cost of generic 
drugs, change the structure of the industry, or advantage any 
particular industry sector, regardless of size or location.
    The program, as negotiated, is aimed at putting FDA's generic drugs 
program on a firm financial footing and providing additive resources 
necessary to assure timely access to safe, high-quality, affordable 
generic drugs.

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 update 
stakeholders and hear stakeholder views on the negotiated proposal for 
a generic drug user fee program. We will conduct the meeting on 
December 19, 2011, from 10 a.m. to 5 p.m. at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 2, rm. 2047, Silver Spring, MD 20993. 
In general, the meeting format will include a presentation by FDA and 
presentations by stakeholders and members of the public who have 
registered in advance to present at the meeting. The amount of time 
available for presentations will be determined by the number of people 
who register to make a presentation. We will also provide an 
opportunity for organizations and individuals to submit written 
comments to the docket after the meeting. FDA policy issues are beyond 
the scope of this initiative. Accordingly, the presentations should 
focus on process and funding issues, and reactions to the GDUFA 
recommendations, and not focus on policy.

B. How do you register for the meeting or submit comments?

    If you wish to attend and/or present at the meeting, please 
register by email to [email protected] by December 12, 2011. 
Your email should contain complete contact information for each 
attendee, including name, title, affiliation, address, email address, 
and telephone 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, as well as the total number of participants, 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, and if the entire 
meeting time is not needed for presentations, FDA reserves the right to 
terminate the meeting early. If you need special accommodations because 
of disability, please contact Mari Long or Peter Beckerman (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 January 6, 2012. 
Submission of comments prior to the meeting is strongly encouraged.

C. Will the meeting be Web cast?

    For those unable to attend in person, FDA will Web cast and provide 
a telephone audio link to the meeting. To join the Web meeting, please 
go to https://collaboration.fda.gov/gdufa/. For audio, please call 301-
796-2700 and enter participant code 121947. If you have never attended 
a Connect Pro meeting before, you may wish to test your connection by 
going to: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.

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 made available in either hard copy or on CD-
ROM, after submission of a Freedom of Information request. Written 
requests are to be sent to the Division of Freedom of Information 
(ELEM)-1029, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857.

    Dated: December 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
 [FR Doc. 2011-31630 Filed 12-6-11; 4:15 pm]