E-drug: French drug firm pleads guilty - pays US$33 Million
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October 19, 2001
FOR IMMEDIATE RELEASE
FOR FURTHER INFORMATION CONTACT
Virginia B. Evans
+1 (410) 209-4885
French Drug Firm Pleads Guilty to Felony: Sentenced to Pay U.S.
$33 Million
Greenbelt- Thomas M. DiBaggio, United States Attorney for the
District of Maryland, Assistant Attorney General Robert D.
McCallum, Jr., of the Department of Justice's Civil Division, and
Bernard A. Schwetz, Acting Commissioner of the Food and Drug
Administration announced today that a French corporation, Roussel
Uclaf S.A., pleaded guilty to felony charges of conspiracy and
defrauding the Food and Drug Administration. U.S. District Judge
Peter J. Messitte then sentenced the company to pay criminal and
civil penalties of over $33,000,000 pursuant to a plea agreement
between Aventis, Pharma A.G. (the successor corporation to
Roussel Uclaf) and the United States Attorney's Office for the
District of Maryland and Department of Justice.
This case represents the first time that a foreign corporation has
been criminally punished based upon defrauding the FDA
concerning a drug product which it manufactured wholly outside
the United States but marketed to the American public. It is also
among the largest monetary penalties ever imposed in a criminal
pharmaceutical prosecution.
Rousell Uclaf pled guilty and was sentenced under a two count
information charging the company with conspiracy and the
introduction of adulterated drugs in interstate commerce with the
intent to defraud or mislead, in violation of the Federal Food, Drug,
and Cosmetic Act.
According to the statement of facts to which a Rousel Uclaf
representative admitted, the case involved Roussel Uclaf's
manufacture of the drug cefaclor in 1995 and 1996 through an
Italian company, Biochimica Opos S.p.A., which was a
wholly-owned subsidiary of Roussel Uclaf. Cefaclor is an antibiotic
used to treat various infections, including upper and lower
respiratory infections, pharingytis, tonsillitis, urinary tract infections,
and skin infections. Although manufactured wholly outside the
United States, Roussel Corporation, another wholly-owned
subsidiary of Roussel Uclaf, distributed cefaclor and other drug
products manufactured by Roussel Uclaf and Biochimica Opos in
the United States.
Since that time, through a series of corporate combinations,
Roussel Uclaf has become part of Aventis S.A. and its
pharmaceutical arm, Aventis Pharma AG. Aventis Pharma, located
in Frankfurt, Germany, is now one of the largest pharmaceutical
companies in the world.
According to facts set forth in the plea agreement, between April
1995 and September 1996, various individuals, including authorized
agents of Roussel Uclaf, willfully sought to mislead the Food and
Drug Administration (FDA) about where and how cefaclor was
being manufactured. The purpose of the illegal scheme was to
increase the amount of cefaclor available for sale by Roussel
Corporation in the United States. Agents of Roussel Uclaf misled
the FDA by falsely representing that cefaclor was being
manufactured at the production facilities listed in an application
relied upon by the FDA when approving the drug for use within the
United States. In fact, these persons knew that other facilities in
Italy, France, and also in Romania were involved in the manufacture
of the drug and that these facilities had not been disclosed to the
FDA.
FDA regulators need to know the location where approved drugs
are manufactured in part so that they can effectively monitor and
inspect the manufacturing facilities and methods used in making
pharmaceuticals. Thus, pharmaceutical manufacturers who legally
import drugs into the United States are required to create and
maintain batch production and control records for each batch of a
drug product, consisting of such information as the identity of each
active and inactive ingredient used, the location of the
manufacturing facility, in-process laboratory control test results, a
description of each step in the drug's manufacturing process, and
the names of all persons performing and supervising each
significant step in the drug's manufacture.
In this case, batch production records at Biochimica Opos' facility
falsely misrepresented the production method for cefaclor and
falsely showed the manufacturing facilities involved in the
production of the drug. In or about May of 1996, members of the
conspiracy actually provided false cefaclor batch records to
inspectors of the Food and Drug Administration who were
conducting an inspection in Biochimica Opos' facility in Agrate
Brianza, Italy, and thus willfully misled the Food and Drug
Administration about where the cefaclor manufacturing processes
were located and how the manufacturing process was being
conducted. In addition, a set of false records were kept regarding
the manufacturing facilities involved, such as raw material log
books, a double software application, and work orders.
United States Attorney Thomas M. DiBiagio stated, "Today's
massive criminal penalty sends an unmistakable message to all
pharmaceutical companies worldwide. If you plan on selling drugs
to the American public, you must play by our rules, whether your
company is located inside or outside the United States. This kind of
fraud will cost you dearly."
"Quality control of pharmaceuticals distributed in our nation is a top
priority," said Assistant Attorney General Robert D. McCallum, Jr.,
head of the Justice Department's Civil Division. "We will not
tolerate any company's efforts to skirt the government's stringent
requirements for the sake of profit over the health of our citizens. "
This case was prosecuted by the Office of Consumer Litigation of
the United States Department of Justice and the United States
Attorney's Office for the District of Maryland. The case was
investigated by the Food and Drug Administration's Office of
Criminal Investigations.
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