[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Notices]
[Pages 60677-60681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5282]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0390]
User Fee Program for Advisory Review of Direct-to-Consumer
Television Advertisements for Prescription Drug and Biological
Products; Request for Notification of Participation and Number of
Advertisements for Review
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice
to explain the new direct-to-consumer (DTC) user fee program (DTC user
fee program) established by the Food and Drug Administration Amendments
Act of 2007 (FDAAA) and, as required by the new law, to ask companies
to notify FDA within 30 calendar days if they intend to participate in
the DTC user fee program during fiscal year (FY) 2008 and, if they do
plan to participate, to identify the number of DTC television
advertisements for prescription drug and biological products they plan
to
[[Page 60678]]
submit for advisory review during FY 2008. The information gathered in
response to this notice will be used to establish the FY 2008 fee that
will be charged for each FY 2008 advisory review submission to FDA and
to fund the operating reserve established under FDAAA.
DATES: Submit written responses by November 26, 2007.
ADDRESSES: Submit written responses by overnight courier service to
Wayne Amchin, Project Manager, Division of Drug Marketing, Advertising,
and Communications (DDMAC), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 1477, Silver Spring, MD 20993-0002. For
companies that use Federal Express or DHL for overnight courier
service, the courier will be able to deliver packages directly to
DDMAC's office. Other courier services will need to call 301-796-1200
to request that the DDMAC project manager meet the courier at the
security desk for package pickup. In addition, fax a copy of your
response to 301-796-9878 or e-mail a copy to dtcp@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT: For questions about the DTC user fee
program, contact Wayne Amchin, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm.
1477, Silver Spring, MD 20993-0002, 301-796-1200, FAX: 301-796-9878, e-
mail: dtcp@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
On September 27, 2007, the President signed into law FDAAA (Public
Law 110-85). Title I of this statute reauthorized the Prescription Drug
User Fee Act (PDUFA) for FYs 2008 to 2012. In addition, Title I also
created new section 736A of the Federal Food, Drug, and Cosmetic Act
(the act), which authorizes a new and separate user fee program for the
advisory review of DTC prescription drug television advertisements.
Participation in the program is voluntary. Sponsors can decide, at
their own discretion, whether to seek FDA advisory review of DTC
prescription drug television advertisements in advance of publicly
broadcasting them. However, under the new law, if a sponsor decides to
seek FDA advisory review of a DTC television advertisement, the sponsor
must pay a required fee for that review. FDA has agreed to use the
resources collected under this program to meet certain performance
goals set forth in an enclosure to letters dated September 27, 2007,
from the Secretary of Health and Human Services (the Secretary) to the
Chairmen and Ranking Minority Members of the Senate Committee on
Health, Education, Labor, and Pensions and the House of Representatives
Committee on Energy and Commerce. The letters are posted at http://
www.fda.gov/cder/pdufa.
FDA is issuing this Federal Register notice to explain the new
program and to ask companies to notify FDA by November 26, 2007: (1) If
they intend to participate in the FY 2008 DTC user fee program and (2)
if they do plan to participate, to identify the number of DTC
television advertisements they plan to submit for advisory review
during FY 2008 to DDMAC in the Center for Drug Evaluation and Research
or the Advertising and Promotional Labeling Branch in the Center for
Biologics Evaluation and Research. The information gathered in response
to this notice will be used to establish the fees that will be charged
for each advisory review submission to FDA during FY 2008 and to create
an operating reserve.
II. Background
FDA's prescription drug advertising regulations give companies the
option of submitting proposed television advertisements to FDA for
advisory review before publicly disseminating them. In this way,
companies can benefit from FDA's advice on whether or not the
advertisements are accurate, balanced, and adequately supported. The
submission of advertisements for advisory review gives sponsors the
opportunity to address any problems before the advertisements are shown
to the public and can improve the quality of the advertisements.
Companies have recognized the benefits of this advisory review
mechanism, and between 2000 and 2006, FDA received an average of
approximately 150 television advertisements for advisory review each
year. Recognizing the value of this review, the Pharmaceutical Research
and Manufacturers of America (PhRMA) recently stated in its voluntary
guiding principles on DTC advertising (see ``PhRMA Guiding Principles;
Direct to Consumer Advertisements About Prescription Medicines'' at
http://www.phrma.org/files/DTCGuidingprinciples.pdf) that companies
should submit all new DTC television advertisements to FDA before
broadcasting them. In addition, FDAAA provides that FDA may require the
submission of drug television advertisements for review before
dissemination. However, this provision does not take effect until 180
days after FDAAA's enactment, and does not affect this user fee
program, which only applies to voluntary submissions for advisory
review.
As FDA's DTC advisory review workload has grown, FDA's ability to
keep pace with the demands for reviews has decreased, and the time it
takes to review DTC materials submitted for advisory review, including
television advertisements, has been increasing. The lack of timely,
predictable FDA review times for DTC television advertisements has
hindered companies' ability to accurately set timeframes for their
marketing campaigns and has discouraged companies from taking advantage
of the DTC advisory review process.
III. DTC User Fee Program
The DTC user fee program is available to companies interested in
voluntarily submitting to FDA for advisory review a DTC television
advertisement for any product that qualifies as a ``prescription drug
product,'' as defined in 21 U.S.C. 379g(3). Under this program, a
company that chooses to submit a DTC television advertisement for
advisory review will be assessed two types of fees: (1) A fee for each
proposed DTC television advertisement submitted for advisory review
prior to its initial public dissemination (``advisory review fee'') and
(2) a fee paid during the company's first year of participation in the
program to establish a reserve fund (``operating reserve fee'').
The decision to seek an advisory review from FDA remains voluntary.
However, FDA will not accept for review any prescription drug DTC
television advertisements voluntarily submitted by a company for
advisory review unless the company has paid both fees.
The payment of an advisory review fee under new section 736A of the
act entitles a company to submit for advisory review by FDA one
proposed predissemination DTC television advertisement, and one
resubmission of the same proposed DTC television advertisement, after
receipt of FDA advisory comments on the initial submission. It should
be noted that fees will not be assessed for advertisements required to
be submitted to FDA prior to initial public dissemination, such as
advertisements for accelerated approval drugs (21 CFR 314.550 and
314.640 (subparts H and I)), biologics (21 CFR 601.45 and 601.94
(subparts E and H)), and submissions required by the Secretary under
section 901 of FDAAA (as it amends the act to add section 503B,
``Prereview of Television Advertisements''), unless the sponsor
voluntarily designates the required
[[Page 60679]]
submission as a submission for advisory review under this program. Fees
also will not be assessed for advisory reviews of advertising or
promotional material other than DTC television advertisements (e.g.,
print advertisements or promotional labeling).
The user fees associated with this program are structured to
provide incentives for companies to join the program in FY 2008 and to
pay all fees on time, as this will give FDA the funding it needs to
hire sufficient staff to review the identified number of advisory
submissions in FY 2008. FDA will recruit staff to conduct reviews based
upon the expected number of submissions for FY 2008 that are identified
in response to this participation notice. Fees for FY 2008 must be paid
in a timely manner to allow FDA to actually obtain these staffing
resources to conduct timely reviews and meet performance metrics during
this year. In addition, the program contains incentives for timely
participation and payment. Participants who do not pay their fees on
time or who join the program late in a fiscal year must pay individual
fees that are 50 percent greater than the established individual fees
for participants who both join the program and pay on time.
IV. Establishing the Advisory Review Fee
A. Process
Congress directed FDA to issue a Federal Register notice, not later
than 30 days after enactment of FDAAA, asking companies to indicate
whether they intend to participate in the DTC user fee program by
voluntarily submitting for FDA advisory review DTC television
advertisements for prescription drugs during FY 2008. Companies that
indicate they intend to participate must specify the number of
advertisements they intend to submit in FY 2008. Once companies have
responded to this notice, FDA will issue another Federal Register
notice establishing the fee for each advisory review submission for FY
2008.
B. Basis for the Fee
The fee will be based on the number of advertisements identified in
response to this participation notice. The advisory review fees in FY
2008 will be set at a level to generate target revenues of $6.25
million in the first year of the program. Individual fees will be
determined by dividing the target revenue, established in the statute,
by the number of proposed television advertisements that all companies
have indicated (in response to the participation notice) that they
intend to submit during FY 2008. For example, if companies indicate
that they intend to submit 150 total advertisements, the fee for each
advisory review submission will be $41,667 ($6.25 million divided by
150). The statute limits this fee to no more than $83,000 per
submission for FY 2008. This limitation is one of several provisions in
the statute that help ensure individual sponsors will not individually
bear a disproportionate share of the cost of the program. The target
revenue figures will be adjusted annually for inflation and workload in
subsequent years. In each subsequent fiscal year of the program, FDA
will issue a new request for notice of participation by June 1 of the
previous fiscal year and a second notice by August 1 of the previous
fiscal year establishing the fees for the fiscal year beginning October
1.
C. Additional Submissions
If, in response to this notice, a participant notifies FDA that it
plans to submit a certain number of advertisements for FY 2008 and then
exceeds that number of advertisements, the participant will be assessed
a fee for each additional submission. The fee will be 50 percent
greater than the established individual fee. In addition, a participant
who does not pay the fees for which it is billed within the timeframe
specified by the Secretary once the fees are set for FY 2008 will be
assessed a penalty that is 50 percent greater than the established
individual fee.
D. Year-to-Year Carry Overs
If a company identifies and pays for more advisory reviews than it
submits in a given fiscal year, the company may carry over one paid
submission for advisory review to the next fiscal year. This means that
a submission for advisory review for which the fee was paid in 1 fiscal
year can be submitted for advisory review in the following fiscal year.
Companies cannot carry over more than one such submission to the next
fiscal year; for unused submissions over and above the one available
for carryover, the paid user fee will not be refunded, waived,
exempted, or reduced. However, resubmissions are not subject to a
fiscal year limitation. For example, a company can submit an
advertisement for advisory review in fiscal year 2008 and resubmit a
revised version of that same advertisement for advisory review in
fiscal year 2009, at no additional cost.
E. Operating Reserves
To establish operating reserves for the program, in the first year
of their participation in the program, participants will be assessed a
one-time participation fee that will be based on the number of
anticipated submissions the participant identifies for that year. In
this way, FDA will collect additional revenues of $6.25 million to be
placed in reserve from which funds can be drawn if target revenues
fluctuate downward in subsequent years. For companies responding by
November 26, 2007, the operating reserve fee for each participant in FY
2008 will be an amount equal to the total amount that company is
charged for its annual advisory review fees for FY 2008. For companies
who respond by November 26, 2007, but do not pay the assessed operating
reserve fee within the timeframe specified by the Secretary, their
operating reserve fee will be 50 percent higher than what they would
have owed had they paid on time. For participants who join the program
late in FY 2008, i.e., those who do not notify FDA of their intent to
participate until after November 26, 2007, the operating reserve fee
will be 50 percent higher than what they would have owed had they both
notified FDA and paid on time. Companies who join the program in
subsequent fiscal years (FYs 2009 to 2012) will be assessed an amount
for the operating reserve fee that will be at least as much as the
amount they would have been assessed if they had joined the program at
the start of FY 2008. Specifically, in subsequent years, the operating
reserve fee for new participants will be the higher of: (1) The total
amount of advisory review fees for all of the new participant's
proposed DTC television advertisements in the fiscal year they join the
program or (2) the total amount of advisory review fees that would have
been assessed in FY 2008 for that number of proposed DTC television
advertisements. This statutory fee structure limits the incentive for
companies to join the program late, which could prevent the program
from receiving sufficient funding in the initial year and place a
disproportionate share of the cost of the program on those participants
who join the program in its initial year of operation.
F. Effect of Inadequate Funding
The statute provides that if FDA fails to receive sufficient
funding from companies within 120 days after enactment of FDAAA, the
program will not commence. Sufficient funding consists of a combined
total amount of
[[Page 60680]]
at least $11.25 million from advisory review fees and operating reserve
fees. In the event that insufficient funding is received and the
program does not commence, all collected fees will be refunded to the
companies that paid.
G. FDA Commitment
The fees will be used to fund approximately 27 additional staff for
predissemination advisory review of DTC television advertisements.
These additional resources will enable FDA to provide more timely
reviews of DTC television advertisements. FDA has committed to phased-
in performance metrics. For example, assuming 150 submissions in FY
2008, FDA will review and provide advisory comments to the sponsor
within 45 days on 50 percent of the 150 original submissions. In
addition, FDA is committed to reviewing 50 percent of resubmissions
within 30 days. The performance metrics will be phased in over the 5
years of the program, with each year including more stringent
performance goals.
V. Request for Notice of Participation
FDA is asking companies that intend to submit advertisements to FDA
for advisory review in FY 2008 to notify FDA by November 26, 2007 of:
(1) Their intent to submit advertisements for advisory review and (2)
the number of DTC television advertisements they plan to submit for
advisory review during FY 2008.
Notification of participation without specifying the number of DTC
television advertisements to be submitted in FY 2008 will be considered
an incomplete notification, and subsequent notification of intent to
submit advertisements after November 26, 2007 would be treated as late.
The agency requests that all companies submit their written
responses within 30 calendar days (see DATES) by overnight courier
service to Wayne Amchin (see ADDRESSES) and fax or e-mail a copy of
their response (see ADDRESSES).
A. What Should Those Wishing To Participate Submit in Their Written
Notification?
The following information should be included in a company's DTC
television advertisement written notification:
A statement that they will submit DTC television
advertisements to FDA for advisory review during FY 2008,
The number of proposed DTC television advertisements they
will submit for advisory review under the DTC user fee program in FY
2008, and
The name, title, billing address, and contact information
(phone, e-mail, fax) of the company representative who will be the
primary person for FDA to contact concerning the company's
participation in the program.
B. What Does Written Notification to FDA Mean?
Each company's written notification to FDA of the number of DTC
television advertisements it intends to submit for advisory review in
FY 2008 is a legally binding commitment by that company to pay the FY
2008 advisory review fee for each submission (see section
736A(a)(1)(D)(ii) of the act). Each person who is assessed an advisory
review fee is also required to pay an operating reserve fee for those
submissions (a one-time fee in the first year of participation to fund
the operating reserve) (see section 736A(a)(2) of the act). FDA will
send invoices to each company for all submissions identified in
response to this notice, and the advisory review fee and the operating
reserve fee for all these submissions are due and payable on the date
specified in the invoices. FDA will also assign each participant a
series of unique user fee ID numbers to correspond with the number of
advisory reviews that the participant identified in response to this
notice. For example, a company identifying 10 advisory reviews will
receive 10 unique user fee ID numbers in its invoice. Each submission
of a DTC television advertisement for FDA advisory review will be
identified with a user fee ID number to show that the fee has been
paid. A company's request for advisory review will be considered
incomplete and submissions will not be accepted for review until all
fees owed by the company for all advisory reviews and the operating
reserve fee have been paid (see section 736A(e) of the act).
C. Can a Company Transfer or Sell its Remaining Balance of User Fee
Credits to Another Company?
For each advisory review fee paid by a person for a fiscal year,
section 736A(a)(1)(F)(i) of the act provides that the person is
entitled to acceptance for advisory review of one DTC advertisement and
acceptance of one resubmission for advisory review of the same
advertisement. Section 736A(a)(1)(F)(i) of the act further provides
that the advertisement shall be submitted for review in the fiscal year
for which the fee was assessed, except that a person may carry over not
more than one paid advisory review submission to the next fiscal year.
FDA will administratively keep track of these submissions as advisory
review credits. Each credit for an advisory review will expire at the
end of the fiscal year for which the user fees were paid, except that
one unused credit can be carried over from the fiscal year in which it
was purchased to the next fiscal year. Advisory review credits are not
transferable, except to a successor in interest (see section
736A(a)(1)(F)(iv) of the act). If unexpired credits are transferred to
a successor in interest, the successor company and former owner should
notify FDA to ensure that future billing of the successor company
reflects prior contributions to the DTC user fee program reserve fund
and the unexpired credit balance. Evidence of a successor in interest
could include a copy of the documentation required under 21 CFR 314.72.
Please contact Wayne Amchin (see FOR INFORMATION CONTACT) concerning
successor in interest issues.
Successors in interest with an unexpired credit balance should also
be aware of the following:
One unused credit can be carried over from the fiscal year
in which it was purchased to the next fiscal year.
In responding to the annual Federal Register notice for
company participation, the successor company must indicate its intent
to use the unexpired carryover credit in the upcoming fiscal year.
D. How Do I Send in DTC Television Advertisements for Advisory Review
Under the DTC User Fee Program?
FDA intends to issue guidance to industry explaining how to submit
DTC advisory review packages for review under the DTC user fee program.
The guidance document will provide details on the contents, format, and
procedures that FDA recommends be followed. The guidance will also
explain how and where to submit advisory review packages to start the
DTC user fee program performance clock. FDA will issue a Federal
Register notice to announce the availability of this guidance.
E. What Happens if I Send in a DTC Television Advertisement for
Advisory Review After October 1, 2007, but Before I'm Invoiced by FDA
for My FY 2008 Fees?
The effective date for the assessment and collection of fees for
DTC television advertisements under this program is October 1, 2007.
Therefore, any DTC television advertisement submitted for advisory
review in FY 2008 is subject to the previously discussed fees under
this program. FDA recognizes that, because of the timing of the
enactment of FDAAA, the advisory review and operating reserve fees for
FY 2008 were
[[Page 60681]]
not established and billed before October 1, 2007, and that there will
be a gap between the start of the fiscal year and the date that fees
are due. However, the voluntary submission of a DTC television
advertisement for FDA advisory review on or after October 1, 2007, but
before November 26, 2007 will be considered by FDA as notification that
the company who submitted the advertisement wishes to participate in
the program and agrees to pay the advisory review fee and operating
reserve fee for each such submission in a timely manner once the fees
for FY 2008 are established and the company is invoiced. Companies who
submit DTC television advertisements for advisory review in this period
should respond to this participation notice, and include any such
submissions in their count of the total number of advisory submissions
they intend to submit in FY 2008. FDA will also contact companies who
submit DTC television advertisements in this time period to request
written confirmation from these companies of their commitment to pay
these fees; if companies do not agree to make this commitment, FDA will
request that they withdraw their submission(s), and such submissions
will not be reviewed. For companies who do agree, FDA will begin its
advisory review of a complete submission of a DTC television
advertisement for advisory review on the date that it receives written
confirmation of the company's commitment to pay the fees associated
with the submission in a timely manner once the company is invoiced.
For information on how FDA will treat DTC television advertisement
advisory review submissions not identified in response to this notice
that are submitted after November 26, 2007, see sections IV.C
``Additional Submissions'' and IV.E ``Operating Reserves'' of this
document.
Dated: October 19, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5282 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S