Agency Information Collection Activities; Comment Request, 16779-16783 [06-3212]
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Federal Register / Vol. 71, No. 64 / Tuesday, April 4, 2006 / Notices
Dated: March 16, 2006.
John C. Dugan,
Comptroller of the Currency.
By order of the Board of Governors of the
Federal Reserve System, March 28, 2006.
Jennifer J. Johnson,
Secretary of the Board.
Dated at Washington, DC, this 29th day of
March, 2006.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
Dated: February 24, 2006.
By the Office of Thrift Supervision.
John M. Reich,
Director.
[FR Doc. 06–3179 Filed 4–3–06; 8:45 am]
BILLING CODE 4810–33–P; 6210–01–P; 6714–01–P;
6720–01–P
FEDERAL RESERVE SYSTEM
Sunshine Act Meeting
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 11:30 a.m., Monday,
April 10, 2006
PLACE: Marriner S. Eccles Federal
Reserve Board Building, 20th and C
Streets, N.W., Washington, D.C. 20551.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
1. Personnel actions (appointments,
promotions, assignments,
reassignments, and salary actions)
involving individual Federal Reserve
System employees.
2. Any items carried forward from a
previously announced meeting.
FOR FURTHER INFORMATION CONTACT:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
SUPPLEMENTARY INFORMATION: You may
call 202–452–3206 beginning at
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
sroberts on PROD1PC70 with NOTICES
AGENCY HOLDING THE MEETING:
Board of Governors of the Federal Reserve
System, March 31, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 06–3276 Filed 3–31–06; 2:03 pm]
BILLING CODE 6210–01–S
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FEDERAL TRADE COMMISSION
Agency Information Collection
Activities; Comment Request
Federal Trade Commission
(‘‘FTC’’ or ‘‘Commission’’).
ACTION: Notice.
AGENCY:
SUMMARY: The FTC is considering
conducting a study to analyze the use
and likely short- and long-run
competitive effects of authorized generic
drugs in the prescription drug
marketplace. Before investigating these
issues, the FTC is soliciting public
comments on its proposed information
requests to firms in the prescription
drug industry. These comments will be
considered before the FTC submits a
request for Office of Management and
Budget (‘‘OMB’’) review under the
Paperwork Reduction Act (‘‘PRA’’), 44
U.S.C. 3501–3520.
DATES: Comments must be received on
or before June 5, 2006.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Authorized
Generic Drug Study: FTC Project No.
P062105’’ to facilitate the organization
of comments. A comment filed in paper
form should include this reference both
in the text and on the envelope and
should be mailed or delivered, with two
complete copies, to the following
address: Federal Trade Commission/
Office of the Secretary, Room H–135
(Annex J), 600 Pennsylvania Avenue,
NW., Washington, DC 20580. Because
paper mail in the Washington area and
at the Commission is subject to delay,
please consider submitting your
comments in electronic form, as
prescribed below. However, if the
comment contains any material for
which confidential treatment is
requested, it must be filed in paper
form, and the first page of the document
must be clearly labeled ‘‘Confidential.’’ 1
The FTC is requesting that any comment
filed in paper form be sent by courier or
overnight service, if possible.
Alternatively, comments may be filed in
electronic form (in ASCII format,
WordPerfect, or Microsoft Word) as part
of or as an attachment to email messages
directed to the following e-mail box:
paperworkcomment@ftc.gov.
1 Commission Rule 4.2(d), 16 CFR 4.2(d). The
comment must be accompanied by an explicit
request for confidential treatment, including the
factual and legal basis for the request, and must
identify the specific portions of the comment to be
withheld from the public record. The request will
be granted or denied by the Commission’s General
Counsel, consistent with applicable law and the
public interest. See Commission Rule 4.9(c), 16 CFR
4.9(c).
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The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. All timely and responsive
public comments will be considered by
the Commission and will be available to
the public on the FTC Web site, to the
extent practicable, at https://www.ftc.gov.
As a matter of discretion, the FTC makes
every effort to remove home contact
information for individuals from the
public comments it receives before
placing those comments on the FTC
Web site. More information, including
routine uses permitted by the Privacy
Act, may be found in the FTC’s privacy
policy at https://www.ftc.gov/ftc/
privacy.htm.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be addressed to Michael S.
Wroblewski, Assistant General Counsel,
Policy Studies, 600 Pennsylvania
Avenue, NW., Washington, DC 20580;
telephone (202) 326–2155.
SUPPLEMENTARY INFORMATION: In the
United States, the Food and Drug
Administration (‘‘FDA’’) must approve
the marketing of any pharmaceutical
drug, whether brand-name or generic.
The Hatch-Waxman Act establishes the
regulatory framework under which the
FDA may approve a generic drug to be
marketed. Typically, a brand-name drug
obtains FDA approval through a New
Drug Application (‘‘NDA’’), and a
generic drug manufacturer obtains FDA
approval through an Abbreviated New
Drug Application (‘‘ANDA’’) in which it
may be allowed to rely on the clinical
data first submitted by the brand-name
drug manufacturer.
To encourage generic entry as soon as
is warranted, the Hatch-Waxman Act
allows generic drug manufacturers, in
certain circumstances, to market a
generic drug prior to the expiration of
claimed patent protection for the
corresponding brand-name drug. To be
permitted to do so, a generic drug
manufacturer must first submit a
‘‘paragraph IV’’ ANDA in which it
certifies that (a) its generic drug will not
infringe patents listed in the FDA’s
‘‘Orange Book’’ (‘‘Orange Book patents’’)
as claiming the relevant brand-name
drug product, and/or (b) the relevant
Orange Book patents are invalid. If the
paragraph IV ANDA leads to litigation,
then 30 months after the litigation was
filed (or after final decision in the
litigation, if earlier), the FDA may
authorize the marketing of the generic
drug under the ANDA application.
At that point, the first-filed paragraph
IV ANDA applicant becomes entitled to
a 180-day marketing exclusivity period,
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during which the FDA cannot approve
any other, later-filed paragraph IV
ANDA for a generic drug corresponding
to the same brand-name drug product.2
This protects the first FDA-approved
paragraph IV ANDA applicant from
competition with other generic ANDA
applicants during this time.
The 180-day marketing exclusivity
period does not preclude competition
from NDA-approved ‘‘authorized
generics,’’ however.3 An authorized
generic is chemically identical to a
particular brand-name drug, which the
brand-name manufacturer authorizes to
be marketed in a generic version under
the NDA-approval that the FDA granted
for the brand-name drug. The brandname manufacturer either sells the
authorized generic itself through a
subsidiary or licenses a generic firm to
sell the authorized generic. The trade
dress typically differs for the brandname drug and its authorized generic
equivalent, but the drug product is
exactly the same.
In recent years and with increasing
frequency, brand-name drug
manufacturers have begun to market
authorized generic drugs at precisely the
same time that a paragraph IV generic is
beginning its period of 180-day
marketing exclusivity. The likely effects
of this practice on generic competition
have been subject to some debate. In the
short run, the entry of an authorized
generic drug may benefit consumers by
creating additional competition that
lowers generic prices further than if
only the paragraph IV generic were
marketed. Many generic manufacturers
assert, however, that in the long run,
consumers will be harmed because an
expectation of competition from
authorized generics will significantly
decrease the incentives of generic
manufacturers to pursue entry prior to
patent expiration. For a generic
manufacturer, the additional
competition from an authorized generic
may result in significantly less profit
during the period of 180-day exclusivity
than if the generic manufacturer had no
authorized-generic competition during
that time.
Currently, there is no publicly
available, comprehensive economic
study that assesses the likely short- and
long-run effects of entry by authorized
2 The 2003 Medicare Prescription Drug
Improvement and Modernization Act of 2003 (Pub.
L. 108–173) revised the precise conditions under
which the FDA can approve a later-filed ANDA. In
general, the exclusivity period lasts until 180 days
after (1) the first commercial marketing of the first
applicant’s generic drug, or (2) a decision of an
appellate court holding the brand-name company’s
patent(s) invalid or not infringed.
3 Teva Pharm. Indus. v. FDA, 410 F.3d 51 (DC Cir.
2005).
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generics on generic competition.4 Given
the importance of generic drugs in
lowering health care costs, Senators
Grassley, Leahy, and Rockefeller have
requested that the Commission conduct
a study of ‘‘the short term and long term
effects on competition of the practice of
‘‘authorized’’ generics.’’ 5 In addition,
Representative Waxman, one of the coauthors of the Hatch-Waxman Act, has
requested that the FTC study ‘‘the
impact of so-called ‘‘authorized
generics’’ on competition in the
prescription drug marketplace.’’ 6
The Commission proposes to
undertake such a study, as described in
this notice, to examine both the likely
short-term competitive effects of
authorized generic drug entry and, to
the extent possible, the likely long-term
impact of entry by authorized generic
drugs on competition by generic
manufacturers.7 Among other things,
the proposed study will examine actual
wholesale prices (including rebates,
discounts, etc.) for brand-name and
generic drugs, both with and without
competition from authorized generics;
business reasons (including profitability
assessments) that support authorized
generic entry; factors (including product
development and litigation costs)
relevant to the decisions of generic firms
about whether and under what
circumstances to seek entry prior to
patent expiration; and licensing
agreements with authorized generics.
These data will enable the proposed
study to make new contributions to the
economic literature on the effects of
generic drug entry on prescription drug
prices and, in particular, the role of the
4 A recent paper by Ernst R. Berndt, et al., funded
by Johnson & Johnson, discusses the issues
involved, but relies solely on data for three drug
products as the bases for its conclusions that
authorized generics benefit consumers and are
unlikely to harm competition. An October 2005
paper by David Reiffen, et al., studies the
magnitude of the effect of authorized generic entry
on generic price, but does not measure this effect
directly and uses data from the late 1980s and early
1990s. The proposed study would include a more
robust and up-to-date analysis of the competitive
effects of authorized generics based on actual
company data.
5 See Letter to Chairman Deborah Platt Majoras,
from Senators Grassley, Leahy, and Rockefeller
(May 9, 2005).
6 See Letter to Chairman Deborah Platt Majoras
from Representative Henry A. Waxman (Sept. 13,
2005).
7 In its 2002 study of how generic drug
competition prior to patent expiration has
developed, the Commission found that the HatchWaxman framework had promoted entry by lowcost generic drugs prior to patent expiration.
Federal Trade Commission, Generic Drug Entry
Prior to Patent Expiration: An FTC Study (July
2002), available at https://www.ftc.gov/os/2002/07/
genericdrugstudy.pdf (‘‘Generic Drug Study’’).
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180-day period of exclusivity in generic
competition prior to patent expiration.
To obtain the relevant data, the
Commission proposes to send special
orders pursuant to Section 6(b) of the
FTC Act, 15 U.S.C. 46(b), to brand-drug
companies with products that have first
faced generic competition since January
1, 1999; 8 generic drug companies that
have marketed authorized generic drugs
since January 1, 1999 (‘‘authorized
generic companies’’); and generic drug
companies that have filed an ANDA
containing paragraph III and IV
certifications since January 1, 1999
(‘‘independent generic companies’’).
The Commission has entered into an
agreement with the FDA to obtain
information to identify the brand-drug
companies and independent generic
companies that meet these criteria.
Information received from the brandname companies in response to the
special orders will permit the
Commission to issue subsequent special
orders to authorized generic companies.
Based on a preliminary analysis,
approximately 80 brand-name drug
manufacturers, 10 authorized generic
drug companies, and 100 independent
generic companies meet these criteria.
Under the PRA, Federal agencies must
obtain approval from OMB for each
collection of information they conduct
or sponsor. ‘‘Collection of information’’
means agency requests or requirements
that members of the public submit
reports, keep records, or provide
information to a third party. 44 U.S.C.
3502(3), 5 CFR 1320.3(c). As required by
the PRA, 44 U.S.C. 3506(c)(2)(A), the
FTC is providing this opportunity for
public comment before requesting that
OMB grant clearance for this survey.
The FTC invites comment on the
following: (1) Whether the proposed
collections of information are necessary
for the proper performance of the
functions of the FTC, including whether
the information will have practical
utility; (2) the accuracy of the FTC’s
estimate of the burden of the proposed
collections of information; (3) ways to
limit the number of companies included
in the study without undermining the
validity and reliability of the study
results (e.g., reduce the number of drug
products studied by only including
those products in an oral solid form,
eliminate those generic companies that
8 We have chosen 1999 as the start of the study
period because in 1998, the FDA changed its
regulations governing eligibility for the 180-day
exclusivity period in response to the decision in
Mova v. Shalala, 140 F.3d 1060 (DC Cir. 1998).
Since then, the FDA has granted the 180-day
exclusivity to substantially more generic applicants
than it had previously. Generic Drug Study at 57.
This proposed study, therefore, will be based on
this altered regulatory landscape.
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have filed only one ANDA during the
study period, reduce the study time
period, etc.); (4) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (5)
ways to minimize the burden of
collecting the information on those who
are to respond, including through the
use of collection techniques or other
form of information technology, e.g.,
permitting electronic submissions of
responses. All comments should be filed
as prescribed in the ADDRESSES section
above, and must be received on or
before June 5, 2006.
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A. Description of the Collection of
Information and Proposed Use
The FTC proposes to send
information requests to approximately
80 brand-name drug manufacturers, 10
authorized generic drug companies, and
100 independent generic companies. As
described above, the brand-name
companies to which the information
requests would be sent include those
companies with products that have first
faced generic drug competition since
January 1, 1999 or that have received
notice of the filing of an ANDA, as
defined by 21 U.S.C. 355(j)(IV), as to one
or more of their products since January
1, 1999. The FTC also proposes to send
special orders to generic drug
companies that have marketed
authorized generic drugs since January
1, 1999. In addition, the FTC proposes
to send special orders to generic drug
companies that filed an ANDA since
January 1, 1999.
In addition to routine questions about
the name, address, organization chart(s),
and incorporation date of the
responding company and its
subsidiaries, and the name, business
address, and official capacity of the
official supervising the company’s
response, the FTC will ask the three
different company types to provide
answers to the following questions for a
list of specific drug products that the
FTC will provide:
Brand-Name Companies
1. For each identified drug product,
submit any documents, including
studies, surveys, analyses, and reports
(both internal and external), that are
dated after January 1, 1998 and were
prepared or received by or for any
senior vice president (or equivalent
position) with product line
responsibility for the specified drug
product or any officer(s) or director(s) of
the company (or, in the case of
unincorporated entities, individuals
exercising similar functions) that
evaluated, considered, analyzed, or
discussed how to respond (including
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through pricing changes) to (a) future or
current generic competition, (b) the
expiration of the patent(s) claiming the
identified drug product or its use, (c)
whether to license or otherwise market
the identified drug product as an
authorized generic drug product, and/or
(d) whether to refrain from marketing an
authorized generic, including but not
limited to, agreements to do so. This
request includes documents that discuss
future generic entry for either specified
products or responses to generic entry
in general. For each such document,
indicate (if not contained in the
document itself) the date of preparation
and the name and title of each
individual who prepared the document,
and group the documents by identified
drug product. If the company licensed
or otherwise authorized the marketing
of the identified drug product as an
authorized generic, provide the license
agreement with the authorized generic
company and the supplemental
application the company filed with the
FDA pursuant to 21 U.S.C. 356a(b) that
had the effect of allowing the company
to license or otherwise market the
identified drug product as an authorized
generic.
2. For each identified drug product,
provide the following information:
a. A detailed description of the
product, including its brand name or
identification number, its common
name, and its biological or chemical
class; its application status at the FDA
for each of its indication(s) or end
use(s), and intended indication(s) or end
use(s), including the date the New Drug
Application was filed and approved,
and the date the product was first
marketed in the United States, as both
a brand-name drug and, if applicable, an
authorized generic;
b. A detailed description of every
SKU of the product as both a brandname drug and, if applicable, an
authorized generic, including product
form, dosage strength, bottle or box size,
route of administration, and the date
first marketed in the United States;
c. The identification number of each
SKU of each product;
d. A list of all patents listed in the
Orange Book for each drug product
whether owned, licensed, or controlled
by the company, including patent or
patent application number, title, priority
date, inventor, date filed, date issued,
date of patent expiration, status, and a
copy of all relevant claims.
3. For each SKU listed in response to
Specification 2c above, state for every
month from a full calendar year
preceding generic entry to the present,
for sales in the United States (e.g., if
generic entry occurred in July 2002, the
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company is to provide the following
information for every month beginning
January 1, 2001):
a. The company’s total sales, net of
discounts, rebates, promotions, returns
and chargebacks, to all customers in
units, total prescriptions, and dollars;
b. The company’s total sales, net of
discounts, rebates, promotions, returns
and chargebacks, to hospitals, clinics
and long-term care facilities, including
but not limited to independent cancer
care centers and pain centers, in units,
total prescriptions, and dollars; 9
c. The company’s standard or actual
cost of goods sold in dollars, reported by
material cost, labor cost, manufacturing
cost, distribution cost, API cost,
overhead cost, other cost, and variances;
d. The company’s prices, including:
(1) List price; (2) average wholesale
price; (3) wholesale acquisition cost; (4)
price to Medicare; (5) price to Medicaid;
(6) the maximum allowable cost; and (7)
average manufacturer price (‘‘AMP’’) as
defined by, and reported to, the Centers
for Medicare and Medicaid Services.
Authorized Generic Company
Questions [If a Brand Drug Company
uses a subsidiary, division, or affiliated
company to distribute the authorized
generic drug, the ‘‘company’’ referred to
in these questions is that subsidiary,
division, or affiliated company.]:
1. For each identified drug product
that is licensed to, or otherwise
marketed by, the company:
a. Provide any documents, including
studies, surveys, analyses, and reports
(both internal and external), that are
dated after January 1, 1998 and were
prepared or received by or for any
senior vice president (or equivalent
position) with product line
responsibility for the specified drug
product or any officer(s) or director(s) of
the company (or, in the case of
unincorporated entities, individuals
exercising similar functions) that
evaluated, considered, analyzed, or
discussed whether or how to proceed
with generic entry, including discussion
related to whether to file an ANDA
containing a paragraph III or IV
certification (regardless of whether the
company filed such ANDA), whether or
when to launch commercial marketing,
and the impact that entry by an
authorized generic drug would have on
generic entry by an ANDA drug product.
This request includes documents that
discuss future generic entry for either
specified products or responses to
generic entry in general. For each such
9 Prescription drugs distributed through hospitals,
clinics and long-term care facilities may have
different pricing structures than those distributed
through retail and mail-order pharmacies.
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document, indicate (if not contained in
the document itself) the date of
preparation and the name and title of
each individual who prepared each
such document;
b. Provide a copy of the license
agreement, or other marketing
authorization, with the brand-name
company.
2. For each identified drug product
that is licensed to, or otherwise
marketed by, the company, provide the
following information:
a. A detailed description of every SKU
of the product, including product form,
dosage strength, bottle or box size, route
of administration, and the date first sold
in the United States;
b. The identification number of each
SKU of each product.
3. For each SKU of each relevant
product listed in response to
Specification 2b above, state for every
month from the date of first commercial
marketing to the present, for sales in the
United States:
a. The company’s total sales, net of
discounts, rebates, promotions, returns
and chargebacks, to all customers in
units, total prescriptions, and dollars;
b. The company’s total sales, net of
discounts, rebates, promotions, returns
and chargebacks, to hospitals, clinics
and long-term care facilities, including
but not limited to independent cancer
care centers and pain centers, in units,
total prescriptions, and dollars;
c. The company’s standard or actual
cost of goods sold in dollars, reported by
material cost, labor cost, manufacturing
cost, distribution cost, API cost,
overhead cost, other cost, and variances;
d. The company’s prices, in each
relevant area, including: (1) List price;
(2) average wholesale price; (3)
wholesale acquisition cost; (4) price to
Medicare; (5) price to Medicaid; (6) the
maximum allowable cost; and (7)
average manufacturer price (‘‘AMP’’) as
defined by, and reported to, the Centers
for Medicare and Medicaid Services.
Independent Generic Company
Questions
1. For each identified product, and for
any other brand drug product for which
the company has evaluated, considered,
analyzed, or discussed whether or how
to proceed with generic entry, submit
the following:
a. Any documents, including studies,
surveys, analyses, and reports (both
internal and external), that are dated
after January 1, 1998 and were prepared
or received by or for any senior vice
president (or equivalent position) with
product line responsibility for the
specified drug product or any officer(s)
or director(s) of the company (or, in the
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case of unincorporated entities,
individuals exercising similar functions)
that evaluated, considered, analyzed, or
discussed whether or how to proceed
with generic entry, including discussion
related to (a) whether to file an ANDA
containing a paragraph III or IV
certification (regardless of whether the
company filed such ANDA), (b) whether
or when to launch commercial
marketing, and/or (c) the impact that
entry by an authorized generic drug
would have on generic entry by the
company’s ANDA drug product. This
request includes documents that discuss
future generic entry for either specified
products or responses to generic entry
in general. For each such document,
indicate (if not contained in the
document itself) the date of preparation
and the name and title of each
individual who prepared each such
document. Submit a copy of the ANDA
application for each identified drug
product;
b. Any documents sufficient to show
the identified product’s development
costs, costs to file ANDA, and patentrelated litigation costs.
2. For each identified product, state
the following:
a. A detailed description of the
product, including its brand name or
identification number, its common
name, and its therapeutic class; its
application status at the FDA for each of
its indication(s) or end use(s), and
intended indication(s) or end use(s),
including the date the application was
filed and approved, and the date the
product was first sold in the United
States;
b. A detailed description of every
SKU of the product, including product
form, dosage strength, bottle or box size,
route of administration, and the date
first sold in the relevant area;
c. The identification number of each
SKU of each product.
3. For each SKU listed in response to
Specification 2c, state for every month
from the date of first commercial
marketing to the present, for sales in the
United States:
a. The company’s total sales, net of
discounts, rebates, promotions, returns
and chargebacks, to all customers in
units, total prescriptions, and dollars;
b. The company’s total sales, net of
discounts, rebates, promotions, returns
and chargebacks, to hospitals, clinics
and long-term care facilities, including
but not limited to independent cancer
care centers and pain centers, in units,
total prescriptions, and dollars;
c. The company’s standard or actual
cost of goods sold in dollars, reported by
material cost, labor cost, manufacturing
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cost, distribution cost, API cost,
overhead cost, other cost, and variances;
d. The company’s prices, in each
relevant area, including: (1) List price;
(2) average wholesale price; (3)
wholesale acquisition cost; (4) price to
Medicare; (5) price to Medicaid; (6) the
maximum allowable cost; and (7)
average manufacturer price (‘‘AMP’’) as
defined by, and reported to, the Centers
for Medicare and Medicaid Services.
For All Three Company Types
The FTC will request IMS Health
(IMS) data if the company obtains such
information in the regular course of
business, as follows:
If the company obtains IMS Health
(IMS) data in the regular course of
business, provide for each identified
drug product, for every month from
January 1999 (or date of first
commercial marketing, where
applicable) to the present for sales in the
United States:
a. IMS Retail Perspective data, or the
equivalent thereof, by product form, by
strength, and by diagnosis, for total sales
in dollars and units, by customer
channel, including, but not limited to
independent pharmacies, chain
pharmacies, mass merchandisers,
proprietary stores, and food stores with
pharmacies;
b. IMS Provider Perspective data, or
the equivalent thereof, by product form,
by strength, and by diagnosis, for total
sales in dollars and units, by customer
channel, including, but not limited to,
non-federal hospitals, federal facilities,
mail order, and long-term care facilities,
clinics, and closed wall HMOs;
c. IMS National Prescription Audit
data, or the equivalent thereof, by
product form, by strength, and by
diagnosis, for newly dispensed
prescriptions, refill dispensed
prescriptions, total dispensed
prescriptions, total units, and total
dollar sales;
d. IMS Retail Method of Payment
Report, or the equivalent thereof, by
product form, by strength, and by
diagnosis, for total sales in dollars and
units, by customer channel, including,
but not limited to, private managed care,
and public managed care;
e. IMS Integrated Promotional
Services Total Promotion Report, by
product form, for total dollars spent for:
(1) Detailing; (2) physician and
pharmacist marketing; (3) medical and
other journal advertising; and (4) any
other promotional spending, including,
but not limited to, direct consumer
advertising;
f. Any other IMS data, or the
equivalent thereof, used in the ordinary
course of business;
E:\FR\FM\04APN1.SGM
04APN1
16783
Federal Register / Vol. 71, No. 64 / Tuesday, April 4, 2006 / Notices
g. All supporting definitions and
materials for any IMS data provided.
The FTC will obtain the information
sought by interrogatories and document
requests under Section 6(b) of the FTC
Act, 15 U.S.C. 46(b). The FTC will use
available information technology (e.g.,
electronic submission of financial
information) to ease the collection of the
requested information.
It should be noted that subsequent to
this notice, any destruction, removal,
mutilation, alteration, or falsification of
documentary evidence that may be
responsive to this information collection
within the possession or control of a
person, partnership or corporation
subject to the FTC Act may be subject
to criminal prosecution. 15 U.S.C. 50;
see also 18 U.S.C. 1505.
The information presented in the
study will not identify companyspecific data. See 15 U.S.C. 57b–
2(d)(1)(B). Rather, the Commission
anticipates using primarily aggregated
totals, on a level sufficient to protect
individual companies’ confidential
information, to provide a factual
summary of the effect of authorized
generic entry since 1999. Section 6(f) of
the FTC Act, 15 U.S.C. 46(f), bars the
Commission from publicly disclosing
trade secrets or confidential commercial
or financial information it receives from
persons pursuant to, among other
methods, special orders authorized by
Section 6(b) of the FTC Act. Such
information also would be exempt from
disclosure under the Freedom of
Information Act. 5 U.S.C. 552(b)(4).
Moreover, under Section 21(c) of the
FTC Act, 15 U.S.C. 57b–2(c), a submitter
who designates a submission as
confidential is entitled to 10 days’
advance notice of any anticipated public
disclosure by the Commission,
assuming that the Commission has
determined that the information does
not, in fact, constitute 6(f) material.
Although materials covered under one
or more of these various sections are
protected by stringent confidentiality
constraints, the FTC Act and the
Commission’s rules authorize disclosure
in limited circumstances (e.g., official
requests by Congress, requests from
other agencies for law enforcement
purposes, administrative or judicial
proceedings). Even in those limited
contexts, however, the Commission’s
rules may afford the submitter advance
notice to seek a protective order. See 15
U.S.C. 57b–2(c); 16 CFR 4.9–4.11.
Task
Total ...............................................................................................................
sroberts on PROD1PC70 with NOTICES
Based on preliminary information, the
FTC anticipates that it will seek
information about 1 to 5 drug products
from approximately 130 companies, for
6 to 10 drug products from 20
companies, and for greater than 10 drug
products from 40 companies. Thus, the
cumulative hours burden to produce
documents and prepare the response
sought will be approximately 39,040
hours (140 hours x 130 companies + 226
x 20 companies + 408 hours x 40
companies).
C. Estimated Cost Burden
It is not possible to calculate with
precision the labor costs associated with
answering the questions and producing
the documents requested, as responses
will entail participation by management
and/or support staff at various
compensation levels among many
18:55 Apr 03, 2006
Jkt 208001
The FTC proposes to use three
different sets of questions for the three
drug company types: Brand-name
companies, authorized generic
companies, and independent generic
companies. The drug products that the
FTC will study will be identified for
each company. Although the questions
vary, the FTC does not anticipate this
will have a significant effect on the
effort required to respond to them.
The FTC has estimated three average
response times depending upon the
number of drug products for which the
company is required to provide a
response: Companies with one to five
drug products, companies with six to 10
drug products, and companies with
more than 10 drug products. The FTC
anticipates that the majority of burden
hours will be primarily to search,
retrieve, and copy relevant documents
necessary to answer question number 1
for each of the company types, and that
the hours necessary to obtain the
financial information will not vary
depending upon the number of drug
products. The total estimated burden to
answer the questions and to produce
documents based on the number of drug
products identified for each company is
based on the following:
6–10 Drug
products
1–5 Drug products
Organize document and information retrieval ......................................................
Identify requested documents ..............................................................................
Retrieve and copy requested documents .............................................................
Identify requested financial information ................................................................
Obtain financial information ..................................................................................
Prepare response .................................................................................................
VerDate Aug<31>2005
B. Estimated Burden Hours
12
12
40
40
12
24
hours ................
..........................
..........................
..........................
..........................
..........................
140 hours ..............
different companies. Individuals among
some or all of those labor categories may
be involved in the information
collection process. Nonetheless, the FTC
has assumed that mid-management
personnel and outside legal counsel will
handle most of the tasks involved in
gathering and producing the responsive
information, and has applied an average
hourly wage of $250/hour for their
labor. Thus, the labor costs per company
should range between $35,000 (140
hours × $250/hour) and $102,000 (408
hours × $250/hour).
The FTC estimates that the capital or
other non-labor costs associated with
the information requests will be
minimal. Although the information
requests may require that respondent
retain copies of the information
provided to the Commission, industry
members should already have in place
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
24
36
60
50
16
40
hours ................
..........................
..........................
..........................
..........................
..........................
226 hours ..............
> 10 Drug products
48 hours
80
120
60
20
80
408 hours.
the means to store information of the
volume requested.
By direction of the Commission,
Commissioner Harbour recused.
Donald S. Clark,
Secretary.
[FR Doc. 06–3212 Filed 4–3–06; 8:45 am]
BILLING CODE 6750–01–P
FEDERAL TRADE COMMISSION
Granting of Request for Early
Termination of the Waiting Period
Under the Premerger Notification
Rules
Section 7A of the Clayton Act, 15
U.S.C. 18a, as added by Title II of the
Hart-Scott-Rodino Antitrust
Improvements Act of 1976, requires
persons contemplating certain mergers
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 71, Number 64 (Tuesday, April 4, 2006)]
[Notices]
[Pages 16779-16783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3212]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Comment Request
AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The FTC is considering conducting a study to analyze the use
and likely short- and long-run competitive effects of authorized
generic drugs in the prescription drug marketplace. Before
investigating these issues, the FTC is soliciting public comments on
its proposed information requests to firms in the prescription drug
industry. These comments will be considered before the FTC submits a
request for Office of Management and Budget (``OMB'') review under the
Paperwork Reduction Act (``PRA''), 44 U.S.C. 3501-3520.
DATES: Comments must be received on or before June 5, 2006.
ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Authorized Generic Drug Study: FTC Project
No. P062105'' to facilitate the organization of comments. A comment
filed in paper form should include this reference both in the text and
on the envelope and should be mailed or delivered, with two complete
copies, to the following address: Federal Trade Commission/Office of
the Secretary, Room H-135 (Annex J), 600 Pennsylvania Avenue, NW.,
Washington, DC 20580. Because paper mail in the Washington area and at
the Commission is subject to delay, please consider submitting your
comments in electronic form, as prescribed below. However, if the
comment contains any material for which confidential treatment is
requested, it must be filed in paper form, and the first page of the
document must be clearly labeled ``Confidential.'' \1\ The FTC is
requesting that any comment filed in paper form be sent by courier or
overnight service, if possible. Alternatively, comments may be filed in
electronic form (in ASCII format, WordPerfect, or Microsoft Word) as
part of or as an attachment to email messages directed to the following
e-mail box: paperworkcomment@ftc.gov.
---------------------------------------------------------------------------
\1\ Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be
accompanied by an explicit request for confidential treatment,
including the factual and legal basis for the request, and must
identify the specific portions of the comment to be withheld from
the public record. The request will be granted or denied by the
Commission's General Counsel, consistent with applicable law and the
public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c).
---------------------------------------------------------------------------
The FTC Act and other laws the Commission administers permit the
collection of public comments to consider and use in this proceeding as
appropriate. All timely and responsive public comments will be
considered by the Commission and will be available to the public on the
FTC Web site, to the extent practicable, at https://www.ftc.gov. As a
matter of discretion, the FTC makes every effort to remove home contact
information for individuals from the public comments it receives before
placing those comments on the FTC Web site. More information, including
routine uses permitted by the Privacy Act, may be found in the FTC's
privacy policy at https://www.ftc.gov/ftc/privacy.htm.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be addressed to Michael S. Wroblewski, Assistant General
Counsel, Policy Studies, 600 Pennsylvania Avenue, NW., Washington, DC
20580; telephone (202) 326-2155.
SUPPLEMENTARY INFORMATION: In the United States, the Food and Drug
Administration (``FDA'') must approve the marketing of any
pharmaceutical drug, whether brand-name or generic. The Hatch-Waxman
Act establishes the regulatory framework under which the FDA may
approve a generic drug to be marketed. Typically, a brand-name drug
obtains FDA approval through a New Drug Application (``NDA''), and a
generic drug manufacturer obtains FDA approval through an Abbreviated
New Drug Application (``ANDA'') in which it may be allowed to rely on
the clinical data first submitted by the brand-name drug manufacturer.
To encourage generic entry as soon as is warranted, the Hatch-
Waxman Act allows generic drug manufacturers, in certain circumstances,
to market a generic drug prior to the expiration of claimed patent
protection for the corresponding brand-name drug. To be permitted to do
so, a generic drug manufacturer must first submit a ``paragraph IV''
ANDA in which it certifies that (a) its generic drug will not infringe
patents listed in the FDA's ``Orange Book'' (``Orange Book patents'')
as claiming the relevant brand-name drug product, and/or (b) the
relevant Orange Book patents are invalid. If the paragraph IV ANDA
leads to litigation, then 30 months after the litigation was filed (or
after final decision in the litigation, if earlier), the FDA may
authorize the marketing of the generic drug under the ANDA application.
At that point, the first-filed paragraph IV ANDA applicant becomes
entitled to a 180-day marketing exclusivity period,
[[Page 16780]]
during which the FDA cannot approve any other, later-filed paragraph IV
ANDA for a generic drug corresponding to the same brand-name drug
product.\2\ This protects the first FDA-approved paragraph IV ANDA
applicant from competition with other generic ANDA applicants during
this time.
---------------------------------------------------------------------------
\2\ The 2003 Medicare Prescription Drug Improvement and
Modernization Act of 2003 (Pub. L. 108-173) revised the precise
conditions under which the FDA can approve a later-filed ANDA. In
general, the exclusivity period lasts until 180 days after (1) the
first commercial marketing of the first applicant's generic drug, or
(2) a decision of an appellate court holding the brand-name
company's patent(s) invalid or not infringed.
---------------------------------------------------------------------------
The 180-day marketing exclusivity period does not preclude
competition from NDA-approved ``authorized generics,'' however.\3\ An
authorized generic is chemically identical to a particular brand-name
drug, which the brand-name manufacturer authorizes to be marketed in a
generic version under the NDA-approval that the FDA granted for the
brand-name drug. The brand-name manufacturer either sells the
authorized generic itself through a subsidiary or licenses a generic
firm to sell the authorized generic. The trade dress typically differs
for the brand-name drug and its authorized generic equivalent, but the
drug product is exactly the same.
---------------------------------------------------------------------------
\3\ Teva Pharm. Indus. v. FDA, 410 F.3d 51 (DC Cir. 2005).
---------------------------------------------------------------------------
In recent years and with increasing frequency, brand-name drug
manufacturers have begun to market authorized generic drugs at
precisely the same time that a paragraph IV generic is beginning its
period of 180-day marketing exclusivity. The likely effects of this
practice on generic competition have been subject to some debate. In
the short run, the entry of an authorized generic drug may benefit
consumers by creating additional competition that lowers generic prices
further than if only the paragraph IV generic were marketed. Many
generic manufacturers assert, however, that in the long run, consumers
will be harmed because an expectation of competition from authorized
generics will significantly decrease the incentives of generic
manufacturers to pursue entry prior to patent expiration. For a generic
manufacturer, the additional competition from an authorized generic may
result in significantly less profit during the period of 180-day
exclusivity than if the generic manufacturer had no authorized-generic
competition during that time.
Currently, there is no publicly available, comprehensive economic
study that assesses the likely short- and long-run effects of entry by
authorized generics on generic competition.\4\ Given the importance of
generic drugs in lowering health care costs, Senators Grassley, Leahy,
and Rockefeller have requested that the Commission conduct a study of
``the short term and long term effects on competition of the practice
of ``authorized'' generics.'' \5\ In addition, Representative Waxman,
one of the co-authors of the Hatch-Waxman Act, has requested that the
FTC study ``the impact of so-called ``authorized generics'' on
competition in the prescription drug marketplace.'' \6\
---------------------------------------------------------------------------
\4\ A recent paper by Ernst R. Berndt, et al., funded by Johnson
& Johnson, discusses the issues involved, but relies solely on data
for three drug products as the bases for its conclusions that
authorized generics benefit consumers and are unlikely to harm
competition. An October 2005 paper by David Reiffen, et al., studies
the magnitude of the effect of authorized generic entry on generic
price, but does not measure this effect directly and uses data from
the late 1980s and early 1990s. The proposed study would include a
more robust and up-to-date analysis of the competitive effects of
authorized generics based on actual company data.
\5\ See Letter to Chairman Deborah Platt Majoras, from Senators
Grassley, Leahy, and Rockefeller (May 9, 2005).
\6\ See Letter to Chairman Deborah Platt Majoras from
Representative Henry A. Waxman (Sept. 13, 2005).
---------------------------------------------------------------------------
The Commission proposes to undertake such a study, as described in
this notice, to examine both the likely short-term competitive effects
of authorized generic drug entry and, to the extent possible, the
likely long-term impact of entry by authorized generic drugs on
competition by generic manufacturers.\7\ Among other things, the
proposed study will examine actual wholesale prices (including rebates,
discounts, etc.) for brand-name and generic drugs, both with and
without competition from authorized generics; business reasons
(including profitability assessments) that support authorized generic
entry; factors (including product development and litigation costs)
relevant to the decisions of generic firms about whether and under what
circumstances to seek entry prior to patent expiration; and licensing
agreements with authorized generics. These data will enable the
proposed study to make new contributions to the economic literature on
the effects of generic drug entry on prescription drug prices and, in
particular, the role of the 180-day period of exclusivity in generic
competition prior to patent expiration.
---------------------------------------------------------------------------
\7\ In its 2002 study of how generic drug competition prior to
patent expiration has developed, the Commission found that the
Hatch-Waxman framework had promoted entry by low-cost generic drugs
prior to patent expiration. Federal Trade Commission, Generic Drug
Entry Prior to Patent Expiration: An FTC Study (July 2002),
available at https://www.ftc.gov/os/2002/07/genericdrugstudy.pdf
(``Generic Drug Study'').
---------------------------------------------------------------------------
To obtain the relevant data, the Commission proposes to send
special orders pursuant to Section 6(b) of the FTC Act, 15 U.S.C.
46(b), to brand-drug companies with products that have first faced
generic competition since January 1, 1999; \8\ generic drug companies
that have marketed authorized generic drugs since January 1, 1999
(``authorized generic companies''); and generic drug companies that
have filed an ANDA containing paragraph III and IV certifications since
January 1, 1999 (``independent generic companies''). The Commission has
entered into an agreement with the FDA to obtain information to
identify the brand-drug companies and independent generic companies
that meet these criteria. Information received from the brand-name
companies in response to the special orders will permit the Commission
to issue subsequent special orders to authorized generic companies.
Based on a preliminary analysis, approximately 80 brand-name drug
manufacturers, 10 authorized generic drug companies, and 100
independent generic companies meet these criteria.
---------------------------------------------------------------------------
\8\ We have chosen 1999 as the start of the study period because
in 1998, the FDA changed its regulations governing eligibility for
the 180-day exclusivity period in response to the decision in Mova
v. Shalala, 140 F.3d 1060 (DC Cir. 1998). Since then, the FDA has
granted the 180-day exclusivity to substantially more generic
applicants than it had previously. Generic Drug Study at 57. This
proposed study, therefore, will be based on this altered regulatory
landscape.
---------------------------------------------------------------------------
Under the PRA, Federal agencies must obtain approval from OMB for
each collection of information they conduct or sponsor. ``Collection of
information'' means agency requests or requirements that members of the
public submit reports, keep records, or provide information to a third
party. 44 U.S.C. 3502(3), 5 CFR 1320.3(c). As required by the PRA, 44
U.S.C. 3506(c)(2)(A), the FTC is providing this opportunity for public
comment before requesting that OMB grant clearance for this survey.
The FTC invites comment on the following: (1) Whether the proposed
collections of information are necessary for the proper performance of
the functions of the FTC, including whether the information will have
practical utility; (2) the accuracy of the FTC's estimate of the burden
of the proposed collections of information; (3) ways to limit the
number of companies included in the study without undermining the
validity and reliability of the study results (e.g., reduce the number
of drug products studied by only including those products in an oral
solid form, eliminate those generic companies that
[[Page 16781]]
have filed only one ANDA during the study period, reduce the study time
period, etc.); (4) ways to enhance the quality, utility, and clarity of
the information to be collected; and (5) ways to minimize the burden of
collecting the information on those who are to respond, including
through the use of collection techniques or other form of information
technology, e.g., permitting electronic submissions of responses. All
comments should be filed as prescribed in the ADDRESSES section above,
and must be received on or before June 5, 2006.
A. Description of the Collection of Information and Proposed Use
The FTC proposes to send information requests to approximately 80
brand-name drug manufacturers, 10 authorized generic drug companies,
and 100 independent generic companies. As described above, the brand-
name companies to which the information requests would be sent include
those companies with products that have first faced generic drug
competition since January 1, 1999 or that have received notice of the
filing of an ANDA, as defined by 21 U.S.C. 355(j)(IV), as to one or
more of their products since January 1, 1999. The FTC also proposes to
send special orders to generic drug companies that have marketed
authorized generic drugs since January 1, 1999. In addition, the FTC
proposes to send special orders to generic drug companies that filed an
ANDA since January 1, 1999.
In addition to routine questions about the name, address,
organization chart(s), and incorporation date of the responding company
and its subsidiaries, and the name, business address, and official
capacity of the official supervising the company's response, the FTC
will ask the three different company types to provide answers to the
following questions for a list of specific drug products that the FTC
will provide:
Brand-Name Companies
1. For each identified drug product, submit any documents,
including studies, surveys, analyses, and reports (both internal and
external), that are dated after January 1, 1998 and were prepared or
received by or for any senior vice president (or equivalent position)
with product line responsibility for the specified drug product or any
officer(s) or director(s) of the company (or, in the case of
unincorporated entities, individuals exercising similar functions) that
evaluated, considered, analyzed, or discussed how to respond (including
through pricing changes) to (a) future or current generic competition,
(b) the expiration of the patent(s) claiming the identified drug
product or its use, (c) whether to license or otherwise market the
identified drug product as an authorized generic drug product, and/or
(d) whether to refrain from marketing an authorized generic, including
but not limited to, agreements to do so. This request includes
documents that discuss future generic entry for either specified
products or responses to generic entry in general. For each such
document, indicate (if not contained in the document itself) the date
of preparation and the name and title of each individual who prepared
the document, and group the documents by identified drug product. If
the company licensed or otherwise authorized the marketing of the
identified drug product as an authorized generic, provide the license
agreement with the authorized generic company and the supplemental
application the company filed with the FDA pursuant to 21 U.S.C.
356a(b) that had the effect of allowing the company to license or
otherwise market the identified drug product as an authorized generic.
2. For each identified drug product, provide the following
information:
a. A detailed description of the product, including its brand name
or identification number, its common name, and its biological or
chemical class; its application status at the FDA for each of its
indication(s) or end use(s), and intended indication(s) or end use(s),
including the date the New Drug Application was filed and approved, and
the date the product was first marketed in the United States, as both a
brand-name drug and, if applicable, an authorized generic;
b. A detailed description of every SKU of the product as both a
brand-name drug and, if applicable, an authorized generic, including
product form, dosage strength, bottle or box size, route of
administration, and the date first marketed in the United States;
c. The identification number of each SKU of each product;
d. A list of all patents listed in the Orange Book for each drug
product whether owned, licensed, or controlled by the company,
including patent or patent application number, title, priority date,
inventor, date filed, date issued, date of patent expiration, status,
and a copy of all relevant claims.
3. For each SKU listed in response to Specification 2c above, state
for every month from a full calendar year preceding generic entry to
the present, for sales in the United States (e.g., if generic entry
occurred in July 2002, the company is to provide the following
information for every month beginning January 1, 2001):
a. The company's total sales, net of discounts, rebates,
promotions, returns and chargebacks, to all customers in units, total
prescriptions, and dollars;
b. The company's total sales, net of discounts, rebates,
promotions, returns and chargebacks, to hospitals, clinics and long-
term care facilities, including but not limited to independent cancer
care centers and pain centers, in units, total prescriptions, and
dollars; \9\
---------------------------------------------------------------------------
\9\ Prescription drugs distributed through hospitals, clinics
and long-term care facilities may have different pricing structures
than those distributed through retail and mail-order pharmacies.
---------------------------------------------------------------------------
c. The company's standard or actual cost of goods sold in dollars,
reported by material cost, labor cost, manufacturing cost, distribution
cost, API cost, overhead cost, other cost, and variances;
d. The company's prices, including: (1) List price; (2) average
wholesale price; (3) wholesale acquisition cost; (4) price to Medicare;
(5) price to Medicaid; (6) the maximum allowable cost; and (7) average
manufacturer price (``AMP'') as defined by, and reported to, the
Centers for Medicare and Medicaid Services.
Authorized Generic Company Questions [If a Brand Drug Company uses
a subsidiary, division, or affiliated company to distribute the
authorized generic drug, the ``company'' referred to in these questions
is that subsidiary, division, or affiliated company.]:
1. For each identified drug product that is licensed to, or
otherwise marketed by, the company:
a. Provide any documents, including studies, surveys, analyses, and
reports (both internal and external), that are dated after January 1,
1998 and were prepared or received by or for any senior vice president
(or equivalent position) with product line responsibility for the
specified drug product or any officer(s) or director(s) of the company
(or, in the case of unincorporated entities, individuals exercising
similar functions) that evaluated, considered, analyzed, or discussed
whether or how to proceed with generic entry, including discussion
related to whether to file an ANDA containing a paragraph III or IV
certification (regardless of whether the company filed such ANDA),
whether or when to launch commercial marketing, and the impact that
entry by an authorized generic drug would have on generic entry by an
ANDA drug product. This request includes documents that discuss future
generic entry for either specified products or responses to generic
entry in general. For each such
[[Page 16782]]
document, indicate (if not contained in the document itself) the date
of preparation and the name and title of each individual who prepared
each such document;
b. Provide a copy of the license agreement, or other marketing
authorization, with the brand-name company.
2. For each identified drug product that is licensed to, or
otherwise marketed by, the company, provide the following information:
a. A detailed description of every SKU of the product, including
product form, dosage strength, bottle or box size, route of
administration, and the date first sold in the United States;
b. The identification number of each SKU of each product.
3. For each SKU of each relevant product listed in response to
Specification 2b above, state for every month from the date of first
commercial marketing to the present, for sales in the United States:
a. The company's total sales, net of discounts, rebates,
promotions, returns and chargebacks, to all customers in units, total
prescriptions, and dollars;
b. The company's total sales, net of discounts, rebates,
promotions, returns and chargebacks, to hospitals, clinics and long-
term care facilities, including but not limited to independent cancer
care centers and pain centers, in units, total prescriptions, and
dollars;
c. The company's standard or actual cost of goods sold in dollars,
reported by material cost, labor cost, manufacturing cost, distribution
cost, API cost, overhead cost, other cost, and variances;
d. The company's prices, in each relevant area, including: (1) List
price; (2) average wholesale price; (3) wholesale acquisition cost; (4)
price to Medicare; (5) price to Medicaid; (6) the maximum allowable
cost; and (7) average manufacturer price (``AMP'') as defined by, and
reported to, the Centers for Medicare and Medicaid Services.
Independent Generic Company Questions
1. For each identified product, and for any other brand drug
product for which the company has evaluated, considered, analyzed, or
discussed whether or how to proceed with generic entry, submit the
following:
a. Any documents, including studies, surveys, analyses, and reports
(both internal and external), that are dated after January 1, 1998 and
were prepared or received by or for any senior vice president (or
equivalent position) with product line responsibility for the specified
drug product or any officer(s) or director(s) of the company (or, in
the case of unincorporated entities, individuals exercising similar
functions) that evaluated, considered, analyzed, or discussed whether
or how to proceed with generic entry, including discussion related to
(a) whether to file an ANDA containing a paragraph III or IV
certification (regardless of whether the company filed such ANDA), (b)
whether or when to launch commercial marketing, and/or (c) the impact
that entry by an authorized generic drug would have on generic entry by
the company's ANDA drug product. This request includes documents that
discuss future generic entry for either specified products or responses
to generic entry in general. For each such document, indicate (if not
contained in the document itself) the date of preparation and the name
and title of each individual who prepared each such document. Submit a
copy of the ANDA application for each identified drug product;
b. Any documents sufficient to show the identified product's
development costs, costs to file ANDA, and patent-related litigation
costs.
2. For each identified product, state the following:
a. A detailed description of the product, including its brand name
or identification number, its common name, and its therapeutic class;
its application status at the FDA for each of its indication(s) or end
use(s), and intended indication(s) or end use(s), including the date
the application was filed and approved, and the date the product was
first sold in the United States;
b. A detailed description of every SKU of the product, including
product form, dosage strength, bottle or box size, route of
administration, and the date first sold in the relevant area;
c. The identification number of each SKU of each product.
3. For each SKU listed in response to Specification 2c, state for
every month from the date of first commercial marketing to the present,
for sales in the United States:
a. The company's total sales, net of discounts, rebates,
promotions, returns and chargebacks, to all customers in units, total
prescriptions, and dollars;
b. The company's total sales, net of discounts, rebates,
promotions, returns and chargebacks, to hospitals, clinics and long-
term care facilities, including but not limited to independent cancer
care centers and pain centers, in units, total prescriptions, and
dollars;
c. The company's standard or actual cost of goods sold in dollars,
reported by material cost, labor cost, manufacturing cost, distribution
cost, API cost, overhead cost, other cost, and variances;
d. The company's prices, in each relevant area, including: (1) List
price; (2) average wholesale price; (3) wholesale acquisition cost; (4)
price to Medicare; (5) price to Medicaid; (6) the maximum allowable
cost; and (7) average manufacturer price (``AMP'') as defined by, and
reported to, the Centers for Medicare and Medicaid Services.
For All Three Company Types
The FTC will request IMS Health (IMS) data if the company obtains
such information in the regular course of business, as follows:
If the company obtains IMS Health (IMS) data in the regular course
of business, provide for each identified drug product, for every month
from January 1999 (or date of first commercial marketing, where
applicable) to the present for sales in the United States:
a. IMS Retail Perspective data, or the equivalent thereof, by
product form, by strength, and by diagnosis, for total sales in dollars
and units, by customer channel, including, but not limited to
independent pharmacies, chain pharmacies, mass merchandisers,
proprietary stores, and food stores with pharmacies;
b. IMS Provider Perspective data, or the equivalent thereof, by
product form, by strength, and by diagnosis, for total sales in dollars
and units, by customer channel, including, but not limited to, non-
federal hospitals, federal facilities, mail order, and long-term care
facilities, clinics, and closed wall HMOs;
c. IMS National Prescription Audit data, or the equivalent thereof,
by product form, by strength, and by diagnosis, for newly dispensed
prescriptions, refill dispensed prescriptions, total dispensed
prescriptions, total units, and total dollar sales;
d. IMS Retail Method of Payment Report, or the equivalent thereof,
by product form, by strength, and by diagnosis, for total sales in
dollars and units, by customer channel, including, but not limited to,
private managed care, and public managed care;
e. IMS Integrated Promotional Services Total Promotion Report, by
product form, for total dollars spent for: (1) Detailing; (2) physician
and pharmacist marketing; (3) medical and other journal advertising;
and (4) any other promotional spending, including, but not limited to,
direct consumer advertising;
f. Any other IMS data, or the equivalent thereof, used in the
ordinary course of business;
[[Page 16783]]
g. All supporting definitions and materials for any IMS data
provided.
The FTC will obtain the information sought by interrogatories and
document requests under Section 6(b) of the FTC Act, 15 U.S.C. 46(b).
The FTC will use available information technology (e.g., electronic
submission of financial information) to ease the collection of the
requested information.
It should be noted that subsequent to this notice, any destruction,
removal, mutilation, alteration, or falsification of documentary
evidence that may be responsive to this information collection within
the possession or control of a person, partnership or corporation
subject to the FTC Act may be subject to criminal prosecution. 15
U.S.C. 50; see also 18 U.S.C. 1505.
The information presented in the study will not identify company-
specific data. See 15 U.S.C. 57b-2(d)(1)(B). Rather, the Commission
anticipates using primarily aggregated totals, on a level sufficient to
protect individual companies' confidential information, to provide a
factual summary of the effect of authorized generic entry since 1999.
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), bars the Commission from
publicly disclosing trade secrets or confidential commercial or
financial information it receives from persons pursuant to, among other
methods, special orders authorized by Section 6(b) of the FTC Act. Such
information also would be exempt from disclosure under the Freedom of
Information Act. 5 U.S.C. 552(b)(4). Moreover, under Section 21(c) of
the FTC Act, 15 U.S.C. 57b-2(c), a submitter who designates a
submission as confidential is entitled to 10 days' advance notice of
any anticipated public disclosure by the Commission, assuming that the
Commission has determined that the information does not, in fact,
constitute 6(f) material. Although materials covered under one or more
of these various sections are protected by stringent confidentiality
constraints, the FTC Act and the Commission's rules authorize
disclosure in limited circumstances (e.g., official requests by
Congress, requests from other agencies for law enforcement purposes,
administrative or judicial proceedings). Even in those limited
contexts, however, the Commission's rules may afford the submitter
advance notice to seek a protective order. See 15 U.S.C. 57b-2(c); 16
CFR 4.9-4.11.
B. Estimated Burden Hours
The FTC proposes to use three different sets of questions for the
three drug company types: Brand-name companies, authorized generic
companies, and independent generic companies. The drug products that
the FTC will study will be identified for each company. Although the
questions vary, the FTC does not anticipate this will have a
significant effect on the effort required to respond to them.
The FTC has estimated three average response times depending upon
the number of drug products for which the company is required to
provide a response: Companies with one to five drug products, companies
with six to 10 drug products, and companies with more than 10 drug
products. The FTC anticipates that the majority of burden hours will be
primarily to search, retrieve, and copy relevant documents necessary to
answer question number 1 for each of the company types, and that the
hours necessary to obtain the financial information will not vary
depending upon the number of drug products. The total estimated burden
to answer the questions and to produce documents based on the number of
drug products identified for each company is based on the following:
----------------------------------------------------------------------------------------------------------------
Task 1-5 Drug products 6-10 Drug products > 10 Drug products
----------------------------------------------------------------------------------------------------------------
Organize document and information 12 hours............... 24 hours............... 48 hours
retrieval.
Identify requested documents......... 12..................... 36..................... 80
Retrieve and copy requested documents 40..................... 60..................... 120
Identify requested financial 40..................... 50..................... 60
information.
Obtain financial information......... 12..................... 16..................... 20
Prepare response..................... 24..................... 40..................... 80
Total............................ 140 hours.............. 226 hours.............. 408 hours.
----------------------------------------------------------------------------------------------------------------
Based on preliminary information, the FTC anticipates that it will
seek information about 1 to 5 drug products from approximately 130
companies, for 6 to 10 drug products from 20 companies, and for greater
than 10 drug products from 40 companies. Thus, the cumulative hours
burden to produce documents and prepare the response sought will be
approximately 39,040 hours (140 hours x 130 companies + 226 x 20
companies + 408 hours x 40 companies).
C. Estimated Cost Burden
It is not possible to calculate with precision the labor costs
associated with answering the questions and producing the documents
requested, as responses will entail participation by management and/or
support staff at various compensation levels among many different
companies. Individuals among some or all of those labor categories may
be involved in the information collection process. Nonetheless, the FTC
has assumed that mid-management personnel and outside legal counsel
will handle most of the tasks involved in gathering and producing the
responsive information, and has applied an average hourly wage of $250/
hour for their labor. Thus, the labor costs per company should range
between $35,000 (140 hours x $250/hour) and $102,000 (408 hours x $250/
hour).
The FTC estimates that the capital or other non-labor costs
associated with the information requests will be minimal. Although the
information requests may require that respondent retain copies of the
information provided to the Commission, industry members should already
have in place the means to store information of the volume requested.
By direction of the Commission, Commissioner Harbour recused.
Donald S. Clark,
Secretary.
[FR Doc. 06-3212 Filed 4-3-06; 8:45 am]
BILLING CODE 6750-01-P