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ELN » Topics » We are subject to extensive government regulation, which may adversely affect our ability to bring new products to market and may adversely affect our ability to manufacture and market our existing products.This excerpt taken from the ELN 6-K filed Mar 30, 2009. We
are subject to extensive government regulation, which may
adversely affect our ability to bring new products to market and
may adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, preclinical and clinical testing,
manufacturing, labelling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved
Table of Contents
marketing applications or licences, recommendations by the FDA
or other regulatory authorities against governmental contracts,
and criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any activities that regulatory authorities consider to be
improper or as a result of changes in regulatory policy.
Regulatory action may have a material adverse effect on the
marketing of a product, require changes in the product’s
labelling or even lead to the withdrawal of the regulatory
marketing approval of the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could result in substantial fines and other
penalties and could cut off our supply of products.
This excerpt taken from the ELN 20-F filed Feb 26, 2009. We are
subject to extensive government regulation, which may adversely
affect our ability to bring new products to market and may
adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, preclinical and clinical testing,
manufacturing, labeling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licenses, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any activities that regulatory authorities consider to be
improper or as a result of changes in regulatory policy.
Regulatory action may have a material adverse effect on the
marketing of a product, require changes in the product’s
labeling or even lead to the withdrawal of the regulatory
marketing approval of the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
Table of Contents
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could result in substantial fines and other
penalties and could cut off our supply of products.
This excerpt taken from the ELN 6-K filed Mar 31, 2008. We
are subject to extensive government regulation, which may
adversely affect our ability to bring new products to market and
may adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, preclinical and clinical testing,
manufacturing, labelling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licences, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any activities that regulatory authorities consider to be
improper or as a result of changes in regulatory policy.
Regulatory action may have a material adverse effect on the
marketing of a product, require changes in the product’s
labelling or even lead to the withdrawal of the regulatory
marketing approval of the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could result in substantial fines and other
penalties and could cut off our supply of products.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. We are
subject to extensive government regulation, which may adversely
affect our ability to bring new products to market and may
adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, preclinical and clinical testing,
manufacturing, labeling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licenses, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that
Table of Contents
could negatively impact the potential profitability of the
approved product. Even after a product is approved, it may be
subject to regulatory action based on newly discovered facts
about the safety and efficacy of the product, on any activities
that regulatory authorities consider to be improper or as a
result of changes in regulatory policy. Regulatory action may
have a material adverse effect on the marketing of a product,
require changes in the product’s labeling or even lead to
the withdrawal of the regulatory marketing approval of the
product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could result in substantial fines and other
penalties and could cut off our supply of products.
This excerpt taken from the ELN 6-K filed Mar 30, 2007. We
are subject to extensive government regulation, which may
adversely affect our ability to bring new products to market and
may adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, pre-clinical and clinical testing,
manufacturing, labelling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licences, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any activities that regulatory authorities consider to be
improper or as a result of changes in regulatory policy.
Regulatory action may have a material adverse effect on the
marketing of a product, require changes in the product’s
labelling or even lead to the withdrawal of the regulatory
marketing approval of the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could have a material adverse effect on us.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. We are
subject to extensive government regulation, which may adversely
affect our ability to bring new products to market and may
adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, pre-clinical and clinical testing,
manufacturing, labeling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licenses, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
Table of Contents
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any activities that regulatory authorities consider to be
improper or as a result of changes in regulatory policy.
Regulatory action may have a material adverse effect on the
marketing of a product, require changes in the product’s
labeling or even lead to the withdrawal of the regulatory
marketing approval of the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could have a material adverse effect on us.
This excerpt taken from the ELN 6-K filed Mar 31, 2006. We are subject to extensive
government regulation, which may adversely affect our ability to
bring new products to market and may adversely affect our
ability to manufacture and market our existing
products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, pre-clinical and clinical testing,
manufacturing, labelling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licences, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any activities that regulatory authorities consider to be
improper or as a result of changes in regulatory policy.
Regulatory action may have a material adverse effect on the
marketing of a product, require changes in the product’s
labelling or even lead to the withdrawal of the regulatory
marketing approval of the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could have a material adverse effect on us.
In May 2001, our wholly-owned subsidiary, Elan Holdings, Inc.
(Elan Holdings) and the late Donal J. Geaney, then our chairman
and chief executive officer, William C. Clark, then president of
operations, and two then employees of Elan Holdings, Hal Herring
and Cheryl Schuster, entered into a consent decree of permanent
injunction with the U.S. Attorney for the Northern District
of Georgia, on behalf of the FDA, relating to alleged violations
of cGMP at our Gainesville facility. The facility manufactured,
and continues to manufacture, verapamil hydrochloride
controlled-release tablets for the treatment of high blood
pressure. The consent decree does not represent an admission by
Elan Holdings or the former officers or employees named above of
any of the allegations set forth in the decree. Under the terms
of the consent decree, which will continue in effect until at
least May 2006, Elan Holdings is permanently enjoined from
violating cGMP regulations. In addition, Elan Holdings was
required to engage an independent expert, subject to FDA
approval, who conducted inspections of the facility through May
2004 in order to ensure the
Elan Corporation, plc 2005 Annual Report 165
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This excerpt taken from the ELN 20-F filed Mar 30, 2006. We are
subject to extensive government regulation, which may adversely
affect our ability to bring new products to market and may
adversely affect our ability to manufacture and market our
existing products.
The pharmaceutical industry is subject to significant regulation
by state, local, national and international governmental
regulatory authorities. In the United States, the FDA regulates
the design, development, pre-clinical and clinical testing,
manufacturing, labelling, storing, distribution, import, export,
record keeping, reporting, marketing and promotion of our
pharmaceutical products, which include drugs, biologics and
medical devices. Failure to comply with regulatory requirements
at any stage during the regulatory process could result in,
among other things, delays in the approval of applications or
supplements to approved applications, refusal of a regulatory
authority to review pending market approval applications or
supplements to approved applications, warning letters, fines,
import or export restrictions, product recalls or seizures,
injunctions, total or partial suspension of production, civil
penalties, withdrawals of previously approved marketing
applications or licenses, recommendations by the FDA or other
regulatory authorities against governmental contracts, and
criminal prosecutions.
We must obtain and maintain approval for our products from
regulatory authorities before such products may be sold in a
particular jurisdiction. The submission of an application to a
regulatory authority with respect to a product does not
guarantee that approval to market the product will be granted.
Each authority generally imposes its own requirements and may
delay or refuse to grant approval, even though a product has
been approved in another country. In our principal markets,
including the United States, the approval process for a new
product is complex, lengthy, expensive and subject to
unanticipated delays. We cannot be sure when or whether
approvals from regulatory authorities will be received or that
the terms of any approval will not impose significant
limitations that could negatively impact the potential
profitability of the approved product. Even after a product is
approved, it may be subject to regulatory action based on newly
discovered facts about the safety and efficacy of the product,
on any
Table of Contents
activities that regulatory authorities consider to be improper
or as a result of changes in regulatory policy. Regulatory
action may have a material adverse effect on the marketing of a
product, require changes in the product’s labelling or even
lead to the withdrawal of the regulatory marketing approval of
the product.
All facilities and manufacturing techniques used for the
manufacture of products and devices for clinical use or for sale
in the United States must be operated in conformity with cGMPs,
the FDA’s regulations governing the production of
pharmaceutical products. There are comparable regulations in
other countries. Any finding by the FDA or other regulatory
authority that we are not in substantial compliance with cGMP
regulations or that we or our employees have engaged in
activities in violation of these regulations could interfere
with the continued manufacture and distribution of the affected
products, up to the entire output of such products, and, in some
cases, might also require the recall of previously distributed
products. Any such finding by the FDA or other regulatory agency
could also affect our ability to obtain new approvals until such
issues are resolved. The FDA and other regulatory authorities
conduct scheduled periodic regulatory inspections of our
facilities to ensure compliance with cGMP regulations. Any
determination by the FDA or other regulatory authority that we,
or one of our suppliers, are not in substantial compliance with
these regulations or are otherwise engaged in improper or
illegal activities could have a material adverse effect on us.
In May 2001, our wholly-owned subsidiary, Elan Holdings, Inc.
(Elan Holdings) and the late Donal J. Geaney, then our chairman
and chief executive officer, William C. Clark, then president of
operations, and two then employees of Elan Holdings, Hal Herring
and Cheryl Schuster, entered into a consent decree of permanent
injunction with the U.S. Attorney for the Northern District
of Georgia, on behalf of the FDA, relating to alleged violations
of cGMP at our Gainesville facility. The facility manufactured,
and continues to manufacture, verapamil hydrochloride
controlled-release tablets for the treatment of high blood
pressure. The consent decree does not represent an admission by
Elan Holdings or the former officers or employees named above of
any of the allegations set forth in the decree. Under the terms
of the consent decree, which will continue in effect until at
least May 2006, Elan Holdings is permanently enjoined from
violating cGMP regulations. In addition, Elan Holdings was
required to engage an independent expert, subject to FDA
approval, who conducted inspections of the facility through May
2004 in order to ensure the facility’s compliance with
cGMP. The first of these inspections was completed and reported
upon by the independent expert to the FDA on September 3,
2002. A corrective action plan was prepared and sent to the FDA
in response to this inspection. A second independent consultant
audit occurred in May 2003 and was reported upon by the
independent expert to the FDA on August 14, 2003. In
response to the inspection, a corrective action plan was
prepared and sent to the FDA. The independent consultant
inspected the facility for the third time in May 2004 and
reported his findings to the FDA in August 2004. The independent
expert found our response and corrective action to that date to
be satisfactory. During the term of the consent decree, we
expect that the facility will be subject to increased FDA
inspections and, under the terms of the consent decree, we will
be required to reimburse the FDA for its costs related to these
inspections.
This excerpt taken from the ELN 6-K filed Apr 11, 2005. We are subject to extensive government regulation, which may adversely affect our ability to bring new products to market and may adversely affect our ability to manufacture and market our existing products. The pharmaceutical industry is subject to significant regulation by state, local, national and international governmental regulatory authorities. In the United States, the FDA regulates the design, development, pre-clinical and clinical testing, manufacturing, labeling, storing, distribution, import, export, record keeping, reporting, marketing and promotion of our pharmaceutical products, which include drugs, biologics and medical devices. Failure to comply with regulatory requirements at any stage during the regulatory process could result in, among other things, delays in the approval of applications or supplements to approved applications, refusal of a regulatory authority to review pending market approval applications or supplements to approved applications, warning letters, fines, import or export restrictions, product recalls or seizures, injunctions, total or partial suspension of production, civil penalties, withdrawals of previously approved marketing applications or licences, recommendations by the FDA or other regulatory authorities against governmental contracts, and criminal prosecutions. We must obtain and maintain approval for our products from regulatory authorities before such products may be sold in a particular jurisdiction. The submission of an application to a regulatory authority with respect to a product does not
Risk Factors guarantee that approval to market the product will be granted. Each authority generally imposes its own requirements and may delay or refuse to grant approval, even though a product has been approved in another country. In our principal markets, including the United States, the approval process for a new product is complex, lengthy, expensive and subject to unanticipated delays. We cannot be sure when or whether approvals from regulatory authorities will be received or that the terms of any approval will not impose significant limitations that could negatively impact the potential profitability of the approved product. Even after a product is approved, it may be subject to regulatory action based on newly discovered facts about the safety and efficacy of the product, on any activities that regulatory authorities consider to be improper or as a result of changes in regulatory policy. Regulatory action may have a material adverse effect on the marketing of a product, require changes in the product’s labeling or even lead to the withdrawal of the regulatory marketing approval of the product. All facilities and manufacturing techniques used for the manufacture of products and devices for clinical use or for sale in the United States must be operated in conformity with cGMPs, the FDA’s regulations governing the production of pharmaceutical products. There are comparable regulations in other countries. Any finding by the FDA or other regulatory authority that we are not in substantial compliance with cGMP regulations or that we or our employees have engaged in activities in violation of these regulations could interfere with the continued manufacture and distribution of the affected products, up to the entire output of such products, and, in some cases, might also require the recall of previously distributed products. Any such finding by the FDA or other regulatory agency could also affect our ability to obtain new approvals until such issues are resolved. The FDA and other regulatory authorities conduct scheduled periodic regulatory inspections of our facilities to ensure compliance with cGMP regulations. Any determination by the FDA or other regulatory authority that we, or one of our suppliers, are not in substantial compliance with these regulations or are otherwise engaged in improper or illegal activities could have a material adverse effect on us. In May 2001, our wholly-owned subsidiary, Elan Holdings and Donal J. Geaney, then our chairman and chief executive officer, William C. Clark, then president of operations, and two then employees of Elan Holdings, Hal Herring and Cheryl Schuster, entered into a consent decree of permanent injunction with the U.S. Attorney for the Northern District of Georgia, on behalf of the FDA, relating to alleged violations of cGMP at our Gainesville facility. The facility manufactured, and continues to manufacture, verapamil hydrochloride controlled-release tablets for the treatment of high blood pressure. The consent decree does not represent an admission by Elan Holdings or the former officers or employees named above of any of the allegations set forth in the decree. Under the terms of the consent decree, which will continue in effect until at least May 2006, Elan Holdings is permanently enjoined from violating cGMP regulations. In addition, Elan Holdings was required to engage an independent expert, subject to FDA approval, who conducted inspections of the facility through May 2004 in order to ensure the facility’s compliance with cGMP. The first of these inspections was completed and reported upon by the independent expert to the FDA on 3 September 2002. A corrective action plan was prepared and sent to the FDA in response to this inspection. A second independent consultant audit occurred in May 2003 and was reported upon by the independent expert to the FDA on 14 August 2003. In response to the inspection, a corrective action plan was prepared and sent to the FDA. The independent consultant inspected the facility for the third time in May 2004 and reported his findings to the FDA in August 2004. The independent expert found our response and corrective action to that date to be satisfactory. During the term of the consent decree, we expect that the facility will be subject to increased FDA inspections and, under the terms of the consent decree, we will be required to reimburse the FDA for its costs related to these inspections. | EXCERPTS ON THIS PAGE:
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