Appointments to the Medicare Payment Advisory Commission, 42735 [2012-17643]
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Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
supply that participate in the market.
Market participants consistently
characterize generic drug markets as
commodity markets in which the
number of generic suppliers has a direct
impact on pricing. Customers and
competitors alike have confirmed that
the price of a generic pharmaceutical
product decreases with the entry of the
second, third, and even fourth and fifth
generic competitor. Further, customers
generally believe that having at least
four suppliers in a generic
pharmaceutical market produces the
most competitive prices.
Evidence gathered during our
investigation indicates that
anticompetitive effects are likely to
result from a decrease in the number of
independent competitors in the markets
at issue. The Proposed Acquisition, by
reducing an already limited number of
competitors or potential competitors in
each of these markets, would cause
anticompetitive harm to U.S. consumers
by increasing the likelihood of higher
post-acquisition prices. In the market for
generic calcipotriene topical solution,
Novartis and Fougera are two of only
three suppliers. In the lidocaineprilocaine cream 30 gram tube market,
Novartis and Fougera are two of only
three suppliers of the product, and the
Proposed Acquisition would eliminate
Fougera as an independent competitor
to Novartis leaving only Hi-Tech. In the
generic lidocaine-prilocaine cream 5–5
gram tubes market, the Acquisition
would result in a merger to monopoly.
In the generic metronidazole gel market,
Novartis and Fougera are two of four
competitors, and combined, Novartis
and Fougera represent 55 percent of the
market. In all of these markets, industry
participants have indicated that the
presence of Fougera as a competitor has
allowed them to negotiate lower prices.
Finally, the Acquisition would
eliminate significant potential
competition between Novartis and
Fougera in the market for the sale of
diclofenac sodium gel. Novartis,
through its agreement with Tolmar, was
the first to file for an approval of a
generic form of Solaraze with the FDA.
Thus, Fougera’s brand, Solaraze, is
likely to face competition solely from
Novartis for a significant period of time
when generic competition is introduced
into this market. As a result, the
Acquisition would increase the
likelihood that the launch of a generic
diclofenac sodium gel product would be
delayed or abandoned altogether and
increase the likelihood that the
combined entity would delay or
eliminate the substantial price
competition that would have resulted
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from the entry of a supplier of a generic
diclofenac sodium gel product.
interpretation of the proposed Order or
to modify its terms in any way.
The Consent Agreement
The proposed Consent Agreement
effectively remedies the Proposed
Acquisition’s anticompetitive effects in
the relevant product markets. Pursuant
to the Consent Agreement, Novartis is
required to return certain rights related
to the relevant products to Tolmar no
later than ten (10) days after the
Acquisition. Specifically, the proposed
Consent Agreement requires that
Novartis: (1) Terminate its marketing
agreement with Tolmar, thereby
returning all of its rights to distribute,
market, and sell the Marketed
Divestiture Products back to Tolmar;
and (2) return all rights to develop,
distribute, market, and sell generic
diclofenac sodium gel to Tolmar.
Tolmar is the Colorado-based developer
and manufacturer of the relevant generic
products.
If Novartis does not fully comply with
its obligations to return all rights to
generic calcipotriene topical solution,
generic lidocaine-prilocaine cream,
generic metronidazole topical gel, and
generic diclofenac sodium gel, the
Commission may appoint a trustee to
effect the return of such rights.
The proposed remedy contains
several provisions to ensure that the
transfer of rights back to Tolmar is
successful. The Consent Agreement
contains an Order to Maintain Assets
that requires Novartis to continue to
market the Marketed Divestiture
Products in a manner that maintains the
full economic viability and
marketability of the businesses until
Tolmar directs Novartis to cease
marketing the Marketed Divestiture
Products or Tolmar’s new marketing
partner commences the distribution,
marketing, and sale of the Marketed
Divestiture Products.
The Commission appointed William
Rahe of Quantic Regulatory Services,
LLC to act as an interim monitor to
assure that Novartis expeditiously
complies with all of its obligations and
performs all of its responsibilities as
required by the Consent Agreement. In
order to ensure that the Commission
remains informed about the status of the
returned rights and assets, the Consent
Agreement requires Novartis to file
reports with the interim monitor who
will report in writing to the Commission
concerning performance by Novartis of
its obligation under the Consent
Agreement.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
By direction of the Commission.
Richard C. Donohue,
Acting Secretary.
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[FR Doc. 2012–17660 Filed 7–19–12; 8:45 am]
BILLING CODE 6750–01–P
GOVERNMENT ACCOUNTABILITY
OFFICE
Appointments to the Medicare
Payment Advisory Commission
Government Accountability
Office (GAO).
ACTION: Notice of appointments.
AGENCY:
The Balanced Budget Act of
1997 established the Medicare Payment
Advisory Commission (MedPAC) and
gave the Comptroller General
responsibility for appointing its
members. This notice announces the
appointment of five new members and
the reappointment of one existing
member.
SUMMARY:
Appointments are effective May
1, 2012.
ADDRESSES: GAO: 441 G Street NW.,
Washington, DC 20548.
MedPAC: 601 New Jersey Avenue
NW., Suite 9000, Washington, DC
20001.
DATES:
FOR FURTHER INFORMATION CONTACT:
GAO: Office of Public Affairs, (202)
512–4800.
MedPAC: Mark E. Miller, Ph.D., (202)
220–3700.
SUPPLEMENTARY INFORMATION: To fill this
year’s vacancies I am announcing the
following:
Newly appointed members are Alice
Coombs, MD, Critical Care Specialist
and Anesthesiologist, South Shore
Hospital; Jack Hoadley, Ph.D., Research
Professor, Health Policy Institute,
Georgetown University; David Nerenz,
Ph.D., Director of the Center for Health
Policy and Health Services Research,
Henry Ford Health System; Rita
Redberg, MD, Professor, Clinical
Medicine, University of California at
San Francisco Medical Center; and Craig
Samitt, MD, President and Chief
Executive Officer, Dean Health System,
Inc.. Their terms will expire in April
2015. The reappointed member is Glenn
M. Hackbarth, J.D., (chair).
(Sec. 4022, Pub. L. 105–33, 111 Stat. 251,
350)
Gene L. Dodaro,
Comptroller General of the United States.
[FR Doc. 2012–17643 Filed 7–19–12; 8:45 am]
BILLING CODE 1610–02–M
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]]>Agencies
[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Page 42735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17643]
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GOVERNMENT ACCOUNTABILITY OFFICE
Appointments to the Medicare Payment Advisory Commission
AGENCY: Government Accountability Office (GAO).
ACTION: Notice of appointments.
-----------------------------------------------------------------------
SUMMARY: The Balanced Budget Act of 1997 established the Medicare
Payment Advisory Commission (MedPAC) and gave the Comptroller General
responsibility for appointing its members. This notice announces the
appointment of five new members and the reappointment of one existing
member.
DATES: Appointments are effective May 1, 2012.
ADDRESSES: GAO: 441 G Street NW., Washington, DC 20548.
MedPAC: 601 New Jersey Avenue NW., Suite 9000, Washington, DC
20001.
FOR FURTHER INFORMATION CONTACT: GAO: Office of Public Affairs, (202)
512-4800.
MedPAC: Mark E. Miller, Ph.D., (202) 220-3700.
SUPPLEMENTARY INFORMATION: To fill this year's vacancies I am
announcing the following:
Newly appointed members are Alice Coombs, MD, Critical Care
Specialist and Anesthesiologist, South Shore Hospital; Jack Hoadley,
Ph.D., Research Professor, Health Policy Institute, Georgetown
University; David Nerenz, Ph.D., Director of the Center for Health
Policy and Health Services Research, Henry Ford Health System; Rita
Redberg, MD, Professor, Clinical Medicine, University of California at
San Francisco Medical Center; and Craig Samitt, MD, President and Chief
Executive Officer, Dean Health System, Inc.. Their terms will expire in
April 2015. The reappointed member is Glenn M. Hackbarth, J.D.,
(chair).
(Sec. 4022, Pub. L. 105-33, 111 Stat. 251, 350)
Gene L. Dodaro,
Comptroller General of the United States.
[FR Doc. 2012-17643 Filed 7-19-12; 8:45 am]
BILLING CODE 1610-02-M
