AbbVie Inc. and Allergan plc; Analysis of Consent Order To Aid Public Comment, 28007-28010 [2020-10081]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
Estimated annual cost: $7,920,000,
includes $91,300 annualized capital or
O&M costs.
Changes in estimates: There is no
change in burden from the previous ICR.
(22) Docket ID Number: EPA–HQ–
OECA–2013–0323; NESHAP for Area
Sources: Electric Arc Furnace
Steelmaking Facilities (40 CFR part 63,
subpart YYYYY) (Renewal); EPA ICR
Number 2277.06; OMB Control Number
2060–0608; Expiration date August 31,
2021.
Respondents: Electric Arc Furnace
(EAF) Steelmaking facilities that are
area sources of HAP emissions.
Respondent’s obligation to respond:
Mandatory (40 CFR part 63, subpart
YYYYY).
Estimated number of respondents: 91.
Frequency of response: Initially,
occasionally, and semiannually.
Estimated annual burden: 4,450
hours.
Estimated annual cost: $467,000,
includes $0 annualized capital or O&M
costs.
Changes in estimates: There is no
change in burden from the previous ICR.
(23) Docket ID Number: EPA–HQ–
OECA–2014–0027; NSPS for Bulk
Gasoline Terminals (40 CFR part 60,
subpart XX) (Renewal); EPA ICR
Number 0664.13; OMB Control Number
2060–0006; Expiration date September
30, 2021.
Respondents: Bulk gasoline terminal
facilities.
Respondent’s obligation to respond:
Mandatory (40 CFR part 60, subpart
XX).
Estimated number of respondents: 40.
Frequency of response: Initially.
Estimated annual burden: 13,200
hours.
Estimated annual cost: $1,390,000,
includes $0 annualized capital or O&M
costs.
Changes in estimates: There is no
change in burden from the previous ICR.
(24) Docket ID Number: EPA–HQ–
OECA–2014–0099; NESHAP for
Ferroalloys Production Area Sources (40
CFR part 63, subpart YYYYYY)
(Renewal); EPA ICR Number 2303.06;
OMB Control Number 2060–0625;
Expiration date September 30, 2021.
Respondents: Ferroalloys production
facilities that are area sources of HAP
emissions.
Respondent’s obligation to respond:
Mandatory (40 CFR part 63, subpart
YYYYYY).
Estimated number of respondents: 10.
Frequency of response: Initially and
annually.
Estimated annual burden: 391 hours.
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
Estimated annual cost: $41,100,
includes $0 annualized capital or O&M
costs.
Changes in estimates: There is no
change in burden from the previous ICR.
Martha Segall,
Acting Director, Monitoring, Assistance and
Media Programs Division, Office of
Compliance.
[FR Doc. 2020–10097 Filed 5–11–20; 8:45 am]
BILLING CODE 6560–50–P
EXPORT-IMPORT BANK OF THE
UNITED STATES
Sunshine Act Meeting; Notice of an
Open Meeting of the Board of Directors
of the Export-Import Bank of the
United States
Thursday, May 21, 2020
at 10:00 a.m.
PLACE: The meeting will be held via
Teleconference.
STATUS: The meeting will be open to
public observation by teleconference.
MATTER TO BE CONSIDERED:
• Item No. 1 Small Business Update.
• Item No. 2 Additionality and
Economic Impact Reforms.
TIME AND DATE:
CONTACT PERSON FOR MORE INFORMATION:
Members of the public who wish to
attend the meeting should email Joyce
Stone, Office of the General Counsel,
811 Vermont Avenue NW, Washington,
DC 20571 (joyce.stone@exim.gov) by
close of business Tuesday, May 19,
2020. Individuals will be given call-in
information upon notice of attendance
to EXIM.
Joyce Stone,
Assistant Corporate Secretary.
[FR Doc. 2020–10220 Filed 5–8–20; 11:15 am]
BILLING CODE 6690–01–P
FEDERAL TRADE COMMISSION
[File No. 191 0169]
AbbVie Inc. and Allergan plc; Analysis
of Consent Order To Aid Public
Comment
Federal Trade Commission.
Proposed consent agreement;
request for comment.
AGENCY:
ACTION:
SUMMARY: The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair methods
of competition. The attached Analysis to
Aid Public Comment describes both the
allegations in the complaint and the
terms of the consent order—embodied
in the consent agreement—that would
settle these allegations.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
28007
Comments must be received on
or before June 11, 2020.
ADDRESSES: Interested parties may file
comments online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Please write: ‘‘AbbVie and
Allergan; File No. 191 0169’’ on your
comment, and file your comment online
at https://www.regulations.gov by
following the instructions on the webbased form. If you prefer to file your
comment on paper, please mail your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue
NW, Suite CC–5610 (Annex D),
Washington, DC 20580; or deliver your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Kari
Wallace (202–326–3085), Bureau of
Competition, Federal Trade
Commission, 600 Pennsylvania Avenue
NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 6(f) of the Federal Trade
Commission Act, 15 U.S.C. 46(f), and
FTC Rule 2.34, 16 CFR 2.34, notice is
hereby given that the above-captioned
consent agreement containing a consent
order to cease and desist, having been
filed with and accepted, subject to final
approval, by the Commission, has been
placed on the public record for a period
of thirty (30) days. The following
Analysis of Agreement Containing
Consent Orders to Aid Public Comment
describes the terms of the consent
agreement and the allegations in the
complaint. An electronic copy of the
full text of the consent agreement
package can be obtained from the FTC
website (for May 5, 2020), at this web
address: https://www.ftc.gov/newsevents/commission-actions.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before June 11, 2020. Write ‘‘AbbVie
and Allergan; File No. 191 0169’’ on
your comment. Your comment—
including your name and your state—
will be placed on the public record of
this proceeding, including, to the extent
practicable, on the https://
www.regulations.gov website.
Due to the public health emergency in
response to the COVID–19 outbreak and
the agency’s heightened security
screening, postal mail addressed to the
Commission will be subject to delay. We
strongly encourage you to submit your
DATES:
E:\FR\FM\12MYN1.SGM
12MYN1
jbell on DSKJLSW7X2PROD with NOTICES
28008
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
comments online through the https://
www.regulations.gov website.
If you prefer to file your comment on
paper, write ‘‘AbbVie and Allergan; File
No. 191 0169’’ on your comment and on
the envelope, and mail your comment to
the following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex D), Washington, DC
20580; or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex D),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will be placed
on the publicly accessible website at
https://www.regulations.gov, you are
solely responsible for making sure that
your comment does not include any
sensitive or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on the public FTC
website—as legally required by FTC
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
website, unless you submit a
confidentiality request that meets the
requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
Visit the FTC website at https://
www.ftc.gov to read this Notice and the
news release describing this matter. The
FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding, as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before June 11, 2020. For information on
the Commission’s privacy policy,
including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/
site-information/privacy-policy.
Analysis of Consent Order To Aid
Public Comment
I. Introduction
The Federal Trade Commission
(‘‘Commission’’) has accepted, subject to
final approval, an Agreement
Containing Consent Orders (‘‘Consent
Agreement’’) from AbbVie Inc.
(‘‘AbbVie’’) and Allergan plc
(‘‘Allergan’’) designed to remedy the
anticompetitive effects resulting from
AbbVie’s proposed acquisition of
Allergan. The proposed Decision and
Order (‘‘Order’’) contained in the
Consent Agreement requires Allergan to
divest all rights and assets related to its
Zenpep and Viokase products to Nestle´
S.A. (‘‘Nestle´’’). The proposed Order
also requires that Allergan return its
rights and assets related to brazikumab
to AstraZeneca plc (‘‘AstraZeneca’’).
The proposed Consent Agreement has
been placed on the public record for
thirty days so that interested persons
may submit comments. Comments
received during this period will become
part of the public record. After thirty
days, the Commission will review the
comments received and decide whether
it should withdraw, modify, or make the
Consent Agreement final.
Pursuant to a Scheme of Arrangement
under Irish law, AbbVie will acquire all
of the voting securities of Allergan from
its shareholders for approximately $63
billion (the ‘‘Acquisition’’). The
Commission’s Complaint alleges that
the proposed Acquisition, if
consummated, would violate Section 7
of the Clayton Act, as amended, 15
U.S.C. 18, and Section 5 of the Federal
Trade Commission Act, as amended, 15
U.S.C. 45, by substantially lessening
competition in the U.S. markets for (1)
prescription drugs for the treatment of
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
exocrine pancreatic insufficiency
(‘‘EPI’’); (2) Interleukin-23 (‘‘IL–23’’)
inhibitors for the treatment of moderateto-severe Crohn’s disease; and (3) IL–23
inhibitors for the treatment of moderateto-severe ulcerative colitis. The
proposed Consent Agreement will
remedy the alleged violations by
preserving the competition that
otherwise would be lost in these
markets as a result of the proposed
Acquisition.
II. The Parties
Headquartered in North Chicago,
Illinois, AbbVie researches, develops,
manufactures, and sells prescription
pharmaceutical products and biologic
products in several therapeutic areas,
including immunology, oncology,
virology, neuroscience, and women’s
health. Among other products, AbbVie
sells a product to treat EPI and is
developing an IL–23 inhibitor to treat
moderate-to-severe Crohn’s disease and
ulcerative colitis. Like AbbVie, Allergan
researches, develops, manufactures, and
sells prescription pharmaceutical
products in the United States. Among
its products, Allergan also sells a
product to treat EPI and is developing
an IL–23 inhibitor to treat moderate-tosevere Crohn’s disease and ulcerative
colitis.
III. The Relevant Products and
Structure of the Markets
A. Drugs for the Treatment of Exocrine
Pancreatic Insufficiency
EPI is a condition that results from a
deficiency of pancreatic enzymes.
Patients who have EPI cannot properly
digest fats, proteins, and carbohydrates
in the foods they eat and, as a result,
may suffer from malnutrition and have
uncomfortable gastrointestinal
symptoms when they eat. EPI is treated
using pancreatic enzyme products.
Pancreatic enzyme products contain the
active ingredient pancrelipase, a
mixture of the digestive enzymes
amylase, lipase, and protease that is
extracted from the pancreas of a pig.
Only four companies sell prescription
pancreatic enzyme product in the
United States: AbbVie, Allergan, Vivus
Inc. (‘‘Vivus’’), and Chiesi USA, Inc.
(‘‘Chiesi’’). AbbVie is the clear market
leader with its product, Creon, and
Allergan is the second-largest supplier,
with its product, Zenpep. Vivus sells
Pancreaze and Chiesi sells Pertzye.
Allergan also sells a second pancreatic
enzyme product, Viokase, although its
sales in the United States are much
more limited. Together, AbbVie and
Allergan have a share of more than 95
E:\FR\FM\12MYN1.SGM
12MYN1
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
percent of the market for drugs to treat
EPI.
V. Competitive Effects of the
Acquisition
B. Interleukin-23 Inhibitors for the
Treatment of Moderate-to-Severe
Crohn’s Disease and for the Treatment
of Moderate-to-Severe Ulcerative Colitis
The proposed Acquisition would
likely result in substantial competitive
harm to consumers in the markets for
prescription drugs for the treatment of
EPI, IL–23 inhibitors for the treatment of
moderate-to-severe Crohn’s disease, and
IL–23 inhibitors for the treatment of
moderate-to-severe ulcerative colitis.
Together, AbbVie and Allergan account
for more than 95 percent of the market
for drugs to treat EPI, and they are two
of a limited number of companies in
late-stage development with IL–23
inhibitors to treat moderate-to-severe
ulcerative colitis and Crohn’s disease.
Ulcerative colitis and Crohn’s disease
are the most common causes of chronic
inflammation of the digestive tract. Both
diseases have similar symptoms—severe
diarrhea, abdominal pain, fatigue, and
weight loss—and both can be
debilitating and lead to life-threatening
complications. The location of the
inflammation is the primary difference
between the two diseases: Ulcerative
colitis is a continuous inflammation of
the colon, affecting only the innermost
lining, while Crohn’s disease can occur
anywhere between the mouth and the
anus, has healthy parts of the digestive
tract between inflamed parts, and can
occur in all layers of the bowel walls.
Because the diseases are similar, drugs
that are effective in treating ulcerative
colitis are also typically effective in
treatment Crohn’s disease (and vice
versa), but the United States Food and
Drug Administration (‘‘FDA’’) requires
that companies seeking ulcerative colitis
and Crohn’s disease indications for
drugs conduct separate clinical studies
and submit separate applications to
market drugs for each indication.
Various drugs are approved to treat
ulcerative colitis and Crohn’s disease,
but the effectiveness for most drugs is
limited. IL–23 inhibitors are a new class
of drugs to treat both diseases. Johnson
& Johnson’s Stelara is the only IL–23
inhibitor currently approved to treat
moderate-to-severe Crohn’s disease and
ulcerative colitis in the United States.
Stelara is both an IL–23 inhibitor and an
Interleukin-12 inhibitor. Only three
other companies—AbbVie, Allergan,
and Eli Lilly and Company—have IL–23
inhibitors in late-stage development for
ulcerative colitis and Crohn’s disease.
Allergan is developing brazikumab and
AbbVie is developing Skyrizi.
jbell on DSKJLSW7X2PROD with NOTICES
IV. The Relevant Geographic Market
The United States is the relevant
geographic market in which to assess
the competitive effects of the proposed
Acquisition. Drugs to treat EPI and
drugs to treat moderate-to-severe
ulcerative colitis and Crohn’s disease
are prescription pharmaceutical
products and regulated by FDA. As
such, products sold outside the United
States, but not approved for sale in the
United States, do not provide viable
competitive alternatives for U.S.
consumers.
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
VI. Entry Conditions
Entry in the relevant markets would
not be timely, likely, or sufficient in
magnitude, character, and scope to deter
or counteract the anticompetitive effects
of the proposed Acquisition. New entry
would require significant investment of
time and money for product research
and development, regulatory approval
by the FDA, developing clinical history
supporting the long-term efficacy of the
product, and establishing a U.S. sales
and service infrastructure. Such
development efforts are difficult, timeconsuming, and expensive, and often
fail to result in a competitive product
reaching the market.
VII. The Consent Agreement
The Consent Agreement eliminates
the competitive concerns raised by the
proposed Acquisition by requiring the
combined company to divest Allergan’s
Zenpep and Viokase business, including
its regulatory approvals, intellectual
property, contracts, and inventory to
Nestle´, and Allergan’s brazikumab
business to AstraZeneca. AbbVie and
Allergan also must transfer all business
information, research and development
information, regulatory, formulation,
and manufacturing reports related to the
divested products, as well as provide
access to knowledgeable employees to
assist in the transfer. The provisions of
the Consent Agreement ensure that
Nestle´ and AstraZeneca become
independent, viable, and effective
competitors in the U.S. markets.
Nestle´ is the world’s largest food and
beverage company, operating in more
than 190 countries around the world.
While the company is most well-known
for its chocolate products, it also
operates Nestle´ Health Science, an
integrated health company that focuses
on nutrition products, including enteral
feeding products that are used in
hospitals and at home by patients who
are unable to chew or swallow food.
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
28009
Nestle´’s existing business includes
products that are highly complementary
to the divestiture assets. Nestle´ has the
expertise, U.S. sales infrastructure, and
resources to restore the competition that
otherwise would have been lost due to
the proposed Acquisition.
AstraZeneca is a global research-based
pharmaceutical company specializing in
researching, developing, manufacturing,
and marketing prescription products.
AstraZeneca was responsible for
conducting some of the early phase
clinical studies for brazikumab, but outlicensed the product to Allergan in
2016. AstraZeneca is a well-qualified
buyer for brazikumab because, as the
original innovator of the product, it
already has experience developing
brazikumab prior to out-licensing it to
Allergan, and, further, the key team
members who were previously
responsible for brazikumab’s
development are still employed by the
company and will take responsibility for
the developing the product. With its
resources, capabilities, and previous
experience with brazikumab,
AstraZeneca is well positioned to
successfully develop and commercialize
the product and thereby replace the
competition that otherwise would have
been lost through the proposed
Acquisition.
AbbVie and Allergan must
accomplish the divestitures no later
than ten days after consummating the
proposed Acquisition. If the
Commission determines that Nestle´ or
AstraZeneca are not acceptable
acquirers, or that the manner of the
divestitures is not acceptable, the
proposed Order requires AbbVie and
Allergan to unwind the sale of rights
and assets and then divest the affected
product to a Commission-approved
acquirer within six months of the date
the Order becomes final. The
Commission has agreed to appoint a
Monitor to ensure that AbbVie and
Allergan comply with all of their
obligations pursuant to the Consent
Agreement and to keep the Commission
informed about the status of the transfer
of the rights and assets to the buyers.
The proposed Order further allows the
Commission to appoint a trustee in the
event that AbbVie and Allergan fail to
divest the products as required.
The purpose of this analysis is to
facilitate public comment on the
Consent Agreement, and it is not
intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
E:\FR\FM\12MYN1.SGM
12MYN1
28010
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2020–10081 Filed 5–11–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–8003]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
July 13, 2020.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ____ , Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS-8003 1915(c) Home and
Community Based Services (HCBS)
Waiver
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: 1915(c)
Home and Community Based Services
(HCBS) Waiver; Use: We will use the
web-based application to review and
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
adjudicate individual waiver actions.
The web-based application will also be
used by states to submit and revise their
waiver requests. Form Number: CMS–
8003 (OMB control number 0938–0449);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 47; Total
Annual Responses: 71; Total Annual
Hours: 6,005. (For policy questions
regarding this collection contact Kathy
Poisal at 410–786–5940.)
Dated: May 7, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–10095 Filed 5–11–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1106, FDA–
2020–D–1137, FDA–2020–D–1138, FDA–
2020–D–1139, and FDA–2020–D–1140]
Guidance Documents Related to
Coronavirus Disease 2019 (COVID–19);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice is pursuant to the process that
FDA announced, in the Federal Register
of March 25, 2020, for making available
to the public COVID–19-related
guidances. The guidances identified in
this notice address issues related to the
COVID–19 PHE and have been issued in
accordance with the process announced
in the March 25, 2020, document. The
guidance documents have been
implemented without prior comment,
but they remain subject to comment in
accordance with the Agency’s good
guidance practices.
DATES: The announcement of the
guidances is published in the Federal
Register on May 12, 2020. The guidance
documents have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28007-28010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10081]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 191 0169]
AbbVie Inc. and Allergan plc; Analysis of Consent Order To Aid
Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement; request for comment.
-----------------------------------------------------------------------
SUMMARY: The consent agreement in this matter settles alleged
violations of federal law prohibiting unfair methods of competition.
The attached Analysis to Aid Public Comment describes both the
allegations in the complaint and the terms of the consent order--
embodied in the consent agreement--that would settle these allegations.
DATES: Comments must be received on or before June 11, 2020.
ADDRESSES: Interested parties may file comments online or on paper, by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Please write: ``AbbVie and
Allergan; File No. 191 0169'' on your comment, and file your comment
online at https://www.regulations.gov by following the instructions on
the web-based form. If you prefer to file your comment on paper, please
mail your comment to the following address: Federal Trade Commission,
Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610
(Annex D), Washington, DC 20580; or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Kari Wallace (202-326-3085), Bureau of
Competition, Federal Trade Commission, 600 Pennsylvania Avenue NW,
Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34,
notice is hereby given that the above-captioned consent agreement
containing a consent order to cease and desist, having been filed with
and accepted, subject to final approval, by the Commission, has been
placed on the public record for a period of thirty (30) days. The
following Analysis of Agreement Containing Consent Orders to Aid Public
Comment describes the terms of the consent agreement and the
allegations in the complaint. An electronic copy of the full text of
the consent agreement package can be obtained from the FTC website (for
May 5, 2020), at this web address: https://www.ftc.gov/news-events/commission-actions.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before June 11, 2020.
Write ``AbbVie and Allergan; File No. 191 0169'' on your comment. Your
comment--including your name and your state--will be placed on the
public record of this proceeding, including, to the extent practicable,
on the https://www.regulations.gov website.
Due to the public health emergency in response to the COVID-19
outbreak and the agency's heightened security screening, postal mail
addressed to the Commission will be subject to delay. We strongly
encourage you to submit your
[[Page 28008]]
comments online through the https://www.regulations.gov website.
If you prefer to file your comment on paper, write ``AbbVie and
Allergan; File No. 191 0169'' on your comment and on the envelope, and
mail your comment to the following address: Federal Trade Commission,
Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610
(Annex D), Washington, DC 20580; or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024. If possible, submit your paper comment to the
Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible
website at https://www.regulations.gov, you are solely responsible for
making sure that your comment does not include any sensitive or
confidential information. In particular, your comment should not
include any sensitive personal information, such as your or anyone
else's Social Security number; date of birth; driver's license number
or other state identification number, or foreign country equivalent;
passport number; financial account number; or credit or debit card
number. You are also solely responsible for making sure your comment
does not include any sensitive health information, such as medical
records or other individually identifiable health information. In
addition, your comment should not include any ``trade secret or any
commercial or financial information which . . . is privileged or
confidential''--as provided by Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)--including in
particular competitively sensitive information such as costs, sales
statistics, inventories, formulas, patterns, devices, manufacturing
processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular,
the written request for confidential treatment that accompanies the
comment must include the factual and legal basis for the request, and
must identify the specific portions of the comment to be withheld from
the public record. See FTC Rule 4.9(c). Your comment will be kept
confidential only if the General Counsel grants your request in
accordance with the law and the public interest. Once your comment has
been posted on the public FTC website--as legally required by FTC Rule
4.9(b)--we cannot redact or remove your comment from the FTC website,
unless you submit a confidentiality request that meets the requirements
for such treatment under FTC Rule 4.9(c), and the General Counsel
grants that request.
Visit the FTC website at https://www.ftc.gov to read this Notice and
the news release describing this matter. The FTC Act and other laws
that the Commission administers permit the collection of public
comments to consider and use in this proceeding, as appropriate. The
Commission will consider all timely and responsive public comments that
it receives on or before June 11, 2020. For information on the
Commission's privacy policy, including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.
Analysis of Consent Order To Aid Public Comment
I. Introduction
The Federal Trade Commission (``Commission'') has accepted, subject
to final approval, an Agreement Containing Consent Orders (``Consent
Agreement'') from AbbVie Inc. (``AbbVie'') and Allergan plc
(``Allergan'') designed to remedy the anticompetitive effects resulting
from AbbVie's proposed acquisition of Allergan. The proposed Decision
and Order (``Order'') contained in the Consent Agreement requires
Allergan to divest all rights and assets related to its Zenpep and
Viokase products to Nestl[eacute] S.A. (``Nestl[eacute]''). The
proposed Order also requires that Allergan return its rights and assets
related to brazikumab to AstraZeneca plc (``AstraZeneca'').
The proposed Consent Agreement has been placed on the public record
for thirty days so that interested persons may submit comments.
Comments received during this period will become part of the public
record. After thirty days, the Commission will review the comments
received and decide whether it should withdraw, modify, or make the
Consent Agreement final.
Pursuant to a Scheme of Arrangement under Irish law, AbbVie will
acquire all of the voting securities of Allergan from its shareholders
for approximately $63 billion (the ``Acquisition''). The Commission's
Complaint alleges that the proposed Acquisition, if consummated, would
violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and
Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C.
45, by substantially lessening competition in the U.S. markets for (1)
prescription drugs for the treatment of exocrine pancreatic
insufficiency (``EPI''); (2) Interleukin-23 (``IL-23'') inhibitors for
the treatment of moderate-to-severe Crohn's disease; and (3) IL-23
inhibitors for the treatment of moderate-to-severe ulcerative colitis.
The proposed Consent Agreement will remedy the alleged violations by
preserving the competition that otherwise would be lost in these
markets as a result of the proposed Acquisition.
II. The Parties
Headquartered in North Chicago, Illinois, AbbVie researches,
develops, manufactures, and sells prescription pharmaceutical products
and biologic products in several therapeutic areas, including
immunology, oncology, virology, neuroscience, and women's health. Among
other products, AbbVie sells a product to treat EPI and is developing
an IL-23 inhibitor to treat moderate-to-severe Crohn's disease and
ulcerative colitis. Like AbbVie, Allergan researches, develops,
manufactures, and sells prescription pharmaceutical products in the
United States. Among its products, Allergan also sells a product to
treat EPI and is developing an IL-23 inhibitor to treat moderate-to-
severe Crohn's disease and ulcerative colitis.
III. The Relevant Products and Structure of the Markets
A. Drugs for the Treatment of Exocrine Pancreatic Insufficiency
EPI is a condition that results from a deficiency of pancreatic
enzymes. Patients who have EPI cannot properly digest fats, proteins,
and carbohydrates in the foods they eat and, as a result, may suffer
from malnutrition and have uncomfortable gastrointestinal symptoms when
they eat. EPI is treated using pancreatic enzyme products. Pancreatic
enzyme products contain the active ingredient pancrelipase, a mixture
of the digestive enzymes amylase, lipase, and protease that is
extracted from the pancreas of a pig.
Only four companies sell prescription pancreatic enzyme product in
the United States: AbbVie, Allergan, Vivus Inc. (``Vivus''), and Chiesi
USA, Inc. (``Chiesi''). AbbVie is the clear market leader with its
product, Creon, and Allergan is the second-largest supplier, with its
product, Zenpep. Vivus sells Pancreaze and Chiesi sells Pertzye.
Allergan also sells a second pancreatic enzyme product, Viokase,
although its sales in the United States are much more limited.
Together, AbbVie and Allergan have a share of more than 95
[[Page 28009]]
percent of the market for drugs to treat EPI.
B. Interleukin-23 Inhibitors for the Treatment of Moderate-to-Severe
Crohn's Disease and for the Treatment of Moderate-to-Severe Ulcerative
Colitis
Ulcerative colitis and Crohn's disease are the most common causes
of chronic inflammation of the digestive tract. Both diseases have
similar symptoms--severe diarrhea, abdominal pain, fatigue, and weight
loss--and both can be debilitating and lead to life-threatening
complications. The location of the inflammation is the primary
difference between the two diseases: Ulcerative colitis is a continuous
inflammation of the colon, affecting only the innermost lining, while
Crohn's disease can occur anywhere between the mouth and the anus, has
healthy parts of the digestive tract between inflamed parts, and can
occur in all layers of the bowel walls. Because the diseases are
similar, drugs that are effective in treating ulcerative colitis are
also typically effective in treatment Crohn's disease (and vice versa),
but the United States Food and Drug Administration (``FDA'') requires
that companies seeking ulcerative colitis and Crohn's disease
indications for drugs conduct separate clinical studies and submit
separate applications to market drugs for each indication.
Various drugs are approved to treat ulcerative colitis and Crohn's
disease, but the effectiveness for most drugs is limited. IL-23
inhibitors are a new class of drugs to treat both diseases. Johnson &
Johnson's Stelara is the only IL-23 inhibitor currently approved to
treat moderate-to-severe Crohn's disease and ulcerative colitis in the
United States. Stelara is both an IL-23 inhibitor and an Interleukin-12
inhibitor. Only three other companies--AbbVie, Allergan, and Eli Lilly
and Company--have IL-23 inhibitors in late-stage development for
ulcerative colitis and Crohn's disease. Allergan is developing
brazikumab and AbbVie is developing Skyrizi.
IV. The Relevant Geographic Market
The United States is the relevant geographic market in which to
assess the competitive effects of the proposed Acquisition. Drugs to
treat EPI and drugs to treat moderate-to-severe ulcerative colitis and
Crohn's disease are prescription pharmaceutical products and regulated
by FDA. As such, products sold outside the United States, but not
approved for sale in the United States, do not provide viable
competitive alternatives for U.S. consumers.
V. Competitive Effects of the Acquisition
The proposed Acquisition would likely result in substantial
competitive harm to consumers in the markets for prescription drugs for
the treatment of EPI, IL-23 inhibitors for the treatment of moderate-
to-severe Crohn's disease, and IL-23 inhibitors for the treatment of
moderate-to-severe ulcerative colitis. Together, AbbVie and Allergan
account for more than 95 percent of the market for drugs to treat EPI,
and they are two of a limited number of companies in late-stage
development with IL-23 inhibitors to treat moderate-to-severe
ulcerative colitis and Crohn's disease.
VI. Entry Conditions
Entry in the relevant markets would not be timely, likely, or
sufficient in magnitude, character, and scope to deter or counteract
the anticompetitive effects of the proposed Acquisition. New entry
would require significant investment of time and money for product
research and development, regulatory approval by the FDA, developing
clinical history supporting the long-term efficacy of the product, and
establishing a U.S. sales and service infrastructure. Such development
efforts are difficult, time-consuming, and expensive, and often fail to
result in a competitive product reaching the market.
VII. The Consent Agreement
The Consent Agreement eliminates the competitive concerns raised by
the proposed Acquisition by requiring the combined company to divest
Allergan's Zenpep and Viokase business, including its regulatory
approvals, intellectual property, contracts, and inventory to
Nestl[eacute], and Allergan's brazikumab business to AstraZeneca.
AbbVie and Allergan also must transfer all business information,
research and development information, regulatory, formulation, and
manufacturing reports related to the divested products, as well as
provide access to knowledgeable employees to assist in the transfer.
The provisions of the Consent Agreement ensure that Nestl[eacute] and
AstraZeneca become independent, viable, and effective competitors in
the U.S. markets.
Nestl[eacute] is the world's largest food and beverage company,
operating in more than 190 countries around the world. While the
company is most well-known for its chocolate products, it also operates
Nestl[eacute] Health Science, an integrated health company that focuses
on nutrition products, including enteral feeding products that are used
in hospitals and at home by patients who are unable to chew or swallow
food. Nestl[eacute]'s existing business includes products that are
highly complementary to the divestiture assets. Nestl[eacute] has the
expertise, U.S. sales infrastructure, and resources to restore the
competition that otherwise would have been lost due to the proposed
Acquisition.
AstraZeneca is a global research-based pharmaceutical company
specializing in researching, developing, manufacturing, and marketing
prescription products. AstraZeneca was responsible for conducting some
of the early phase clinical studies for brazikumab, but out-licensed
the product to Allergan in 2016. AstraZeneca is a well-qualified buyer
for brazikumab because, as the original innovator of the product, it
already has experience developing brazikumab prior to out-licensing it
to Allergan, and, further, the key team members who were previously
responsible for brazikumab's development are still employed by the
company and will take responsibility for the developing the product.
With its resources, capabilities, and previous experience with
brazikumab, AstraZeneca is well positioned to successfully develop and
commercialize the product and thereby replace the competition that
otherwise would have been lost through the proposed Acquisition.
AbbVie and Allergan must accomplish the divestitures no later than
ten days after consummating the proposed Acquisition. If the Commission
determines that Nestl[eacute] or AstraZeneca are not acceptable
acquirers, or that the manner of the divestitures is not acceptable,
the proposed Order requires AbbVie and Allergan to unwind the sale of
rights and assets and then divest the affected product to a Commission-
approved acquirer within six months of the date the Order becomes
final. The Commission has agreed to appoint a Monitor to ensure that
AbbVie and Allergan comply with all of their obligations pursuant to
the Consent Agreement and to keep the Commission informed about the
status of the transfer of the rights and assets to the buyers. The
proposed Order further allows the Commission to appoint a trustee in
the event that AbbVie and Allergan fail to divest the products as
required.
The purpose of this analysis is to facilitate public comment on the
Consent Agreement, and it is not intended to constitute an official
interpretation of the proposed Order or to modify its terms in any way.
[[Page 28010]]
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2020-10081 Filed 5-11-20; 8:45 am]
BILLING CODE 6750-01-P
