[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76738-76740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31630]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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,
2011.
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
document).
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].
SUPPLEMENTARY INFORMATION:
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
process.
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
fee.
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]
BILLING CODE 4160-01-P