Importer of Controlled Substances, Notice of Application, Mylan Pharmaceuticals, Inc., 12620-12621 [2012-4992]
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Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Notices
2801 Alaskan Way Suite 300—Pier 70
Seattle, WA 98121–1128
dlundsgaard@grahamdunn.com
3. Counsel for Billings Clinic; Bozeman
Deaconess Health Services, Inc.;
Community Medical Center, Inc.;
New West Health Services, Inc.;
Northern Montana Health Care,
Inc.; and St. Peter’s Hospital:
Kevin P. Heaney
Crowley Fleck PLLP
Transwestern Plaza II
490 N. 31st St., Suite 500
Billings, MT 59101
kheaney@crowleyfleck.com
mstockstill on DSK4VPTVN1PROD with NOTICES
/s/ Scott I. Fitzgerald
Scott I. Fitzgerald,
Antitrust Division, U.S. Department of
Justice, 450 Fifth Street NW., Suite 4100,
Washington, DC 20530, (202) 353–3863,
scott.fitzgerald@usdoj.gov.
AMA—AMERICAN MEDICAL
ASSOCIATION
James Madara, Executive Vice President,
CEO
American Medical Association
515 N. State Street
Chicago, Illinois 60654
amarassn.org
(p) 312.464.5000
(f) 312.464.4184
January 13, 2012
Mr. Joshua H. Soven,
Chief, Litigation I Section,
Antitrust Division,
United States Department of Justice,
450 5th Street, N, Suite 4700,
Washington, DC 20530.
Re: Comments to Proposed Consent
Judgment in U.S. v. Blue Cross and
Blue Shield of Montana, Inc., et al.
[FR Doc. 2011–29656]
Dear Mr. Soven:
On behalf of the physician and
medical student members of the
American Medical Association (AMA), I
appreciate the opportunity to provide
comments in response to the action by
the Antitrust Division of the Department
of Justice (DOJ) in the matter of Blue
Cross and Blue Shield of Montana, Inc.
(Blue Cross) and several Montana-area
hospitals (the Hospital Defendants) in
U.S. v. Blue Cross and Blue Shield of
Montana, Inc., et al., Civil Action No.
1:11–cv–00123–RFC. This action
represents an important step towards
reining in health insurers and hospitals
whose actions conspire to restrain
competition and maintain monopolized
health insurance markets.
Accordingly, the DOJ has acted in the
public interest with the proposed
decree, and the AMA submits the
following comments in support.
According to the DOJ’s complaint, Blue
Cross agreed to pay $26.3 million to the
Hospital Defendants in exchange for
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their agreement to collectively stop
purchasing health insurance from New
West Health Services, an insurer owned
by the Hospital Defendants, and instead
buy from Blue Cross exclusively for six
years (the Agreement). The Agreement,
it is alleged, would likely cause New
West to exit the relevant Montana
markets for commercial health
insurance. Because New West is Blue
Cross’s only viable competitor, the
Agreement would have eliminated all
competition. Accordingly, as the
Complaint alleges, the Agreement
would have led to higher prices and
lower quality service for consumers.
The AMA applauds the DOJ for its
vigilance in recognizing the
anticompetitive conduct described
above and for fashioning a remedy that
holds the promise of nurturing
competition in Montana. For years, the
AMA has been expressing its concern
over the lack of competition in health
insurance markets nationally. In its
most recent study of health insurance
markets, the AMA found that 83% of
the 368 metropolitan areas studied
qualify as highly concentrated areas,
while in 95% of these markets, at least
one insurer has a market share of 30%
or greater. See, ‘‘Competition in Health
Insurance: A Comprehensive Study of
U.S. Markets,’’ American Medical
Association (AMA) (2011 update).
Health insurance markets that are
monopolized not only hurt consumers
directly, they also enable health insurers
to exercise monopsony power in
physician markets, eventually leading to
reductions in service levels and quality
of care. The market conditions in
Montana are consistent with what the
AMA has found nationally.
Blue Cross’ dominance in Montana
health insurance markets presents a
significant barrier to the market success
of smaller rivals such as New West,
even assuming the absence of
exclusionary conduct such as that
alleged in this case. In 2010, then
Assistant Attorney General Christine
Varney reported that the DOJ found that
new health insurer entrants cannot
compete with incumbents for potential
purchasers of their products unless the
new entrants can offer similar provider
discounts to their enrollees—but they
cannot offer these competitive discounts
without being able to promise providers
a significant number of enrollees to
make such an arrangement viable. In
turn, these barriers of entry create an
anticompetitive environment in which
the dominant insurer can achieve lower
input prices by demanding lower rates
from providers (who face a significant
loss of revenue if they refuse such
demands), without having to lower their
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consumer output prices (the cost of their
premiums).1
In the instant case, the DOJ has
fashioned a pro-competitive remedy that
addresses the entry barriers faced by
small Blue Cross rivals such as New
West. First, the proposed final judgment
would eliminate the anticompetitive
effects of the challenged Agreement by
requiring New West and the Hospital
Defendants to divest New West’s
commercial health insurance business.
Tentative arrangements call for the
acquiring entity to be PacificSource,
which is an established health insurer
in the Pacific Northwest. To overcome
Blue Cross’ advantage in obtaining
discounts from the Hospital Defendants
because of its size, the proposed consent
decree creatively requires New West
and the Hospital Defendants to help
provide PacificSource with a costcompetitive provider network. The
Hospital Defendants are required to sign
three-year hospital contracts with
PacificSource on terms substantially
similar to the existing contractual terms
with New West. The decree also
requires Blue Cross to provide thirty
days’ written notice to the DOJ before
entering into any exclusive contracts
with health insurance brokers—
contracts that might hinder important
health insurer access to brokers. These
provisions will help ensure that
PacificSource will be able to compete as
effectively as New West before the
parties entered the Agreement.
In sum, the divestiture of New West
mandated in the proposed consent
decree will reverse the anticompetitive
effects of the challenged Agreement,
while the additional provisions may
foster an even more robust competition
within the market than existed before
the Agreement. Given the weak state of
health insurer competition in Montana,
we applaud the DOJ for creating this
remedy in the public interest.
Sincerely,
James L. Madara, MD.
[FR Doc. 2012–4862 Filed 2–29–12; 8:45 am]
BILLING CODE M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Application, Mylan
Pharmaceuticals, Inc.
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
1 See, Speech by Christine Varney, Assistant
Attorney General Antitrust Division, U.S.
Department of Justice at American Bar Association/
American Health Lawyers Association Antitrust in
Healthcare Conference, May 24, 2010.
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01MRN1
Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Notices
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on
December 30, 2011, Mylan
Pharmaceuticals, Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia
26505, made application by letter to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Amphetamine (1100) ....................
Methadone (9250) ........................
Morphine (9300) ...........................
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances may file comments or
objections to the issuance of the
proposed registration and may, at the
same time, file a written request for a
hearing on such application pursuant to
21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than April 2, 2012.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedule I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
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17:25 Feb 29, 2012
Jkt 226001
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
12621
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
[FR Doc. 2012–4992 Filed 2–29–12; 8:45 am]
Dated: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
[FR Doc. 2012–4994 Filed 2–29–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Pharmaceuticals Inc.
By Notice dated December 22, 2011,
and published in the Federal Register
on December 29, 2011, 76 FR 81978,
Mylan Pharmaceuticals, Inc., 781
Chestnut Ridge Road, Morgantown,
West Virginia 26505, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following basic
classes of controlled substances:
Drug
Schedule
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Fentanyl (9801) ............................
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Mylan Pharmaceuticals, Inc. to import
the basic classes of controlled
substances is consistent with the public
interest, and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. DEA has investigated
Mylan Pharmaceuticals, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
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DEPARTMENT OF JUSTICE
Parole Commission
Sunshine Act Meeting
1:30 p.m., Thursday,
March 8, 2012.
PLACE: U.S. Parole Commission, 90 K
Street NE., 3rd Floor, Washington, DC.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
Consideration of two original
jurisdiction cases pursuant to 28 CFR
2.27.
TIME AND DATE:
CONTACT PERSON FOR MORE INFORMATION:
Patricia W. Moore, Staff Assistant to the
Chairman, U.S. Parole Commission, 90
K Street NE., 3rd Floor, Washington, DC
20530, (202) 346–7001.
Dated: February 27, 2012.
Rockne Chickinell,
General Counsel, U.S. Parole Commission.
[FR Doc. 2012–5183 Filed 2–28–12; 4:15 pm]
BILLING CODE 4410–31–P
MISSISSIPPI RIVER COMMISSION
Sunshine Act Meetings
Agency Holding the Meetings:
Mississippi River Commission.
AGENCY:
Time and Date: 9 a.m., March 26,
2012.
Place: On board MISSISSIPPI V at
River Park, Tiptonville, TN.
Status: Open to the public.
Matters To Be Considered: (1)
Summary report by President of the
Commission on national and regional
issues affecting the U.S. Army Corps of
Engineers and Commission programs
and projects on the Mississippi River
and its tributaries; (2) District
Commander’s overview of current
project issues within the Memphis
District; and (3) Presentations by local
organizations and members of the
public giving views or comments on any
issue affecting the programs or projects
of the Commission and the Corps of
Engineers.
DATES:
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Pages 12620-12621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4992]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Application, Mylan
Pharmaceuticals, Inc.
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing
[[Page 12621]]
a registration under this Section to a bulk manufacturer of a
controlled substance in schedule I or II, and prior to issuing a
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of
such a substance, provide manufacturers holding registrations for the
bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with 21 CFR 1301.34(a), this is notice
that on December 30, 2011, Mylan Pharmaceuticals, Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia 26505, made application by letter
to the Drug Enforcement Administration (DEA) to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically-manufactured FDF. This analysis is required
to allow the company to export domestically-manufactured FDF to foreign
markets.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances may file comments or objections to the issuance of the
proposed registration and may, at the same time, file a written request
for a hearing on such application pursuant to 21 CFR 1301.43, and in
such form as prescribed by 21 CFR 1316.47.
Any such written comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than April 2, 2012.
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR 1301.34(b), (c),
(d), (e), and (f). As noted in a previous notice published in the
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants
for registration to import a basic class of any controlled substance in
schedule I or II are, and will continue to be, required to demonstrate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, that the requirements for such
registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR
1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-4992 Filed 2-29-12; 8:45 am]
BILLING CODE 4410-09-P
