E-drug: FDA: Schering to pay USD500 mill for quality defects
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See also posting today from NY Times on quality problems in the
pharmaceutical industry. The NY Times article on Schering can be found at:
http://www.nytimes.com/2002/05/18/business/18DRUG.html?tntemail1
KM, moderator]
FOR IMMEDIATE RELEASE
P02-15
May 17, 2002
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
SCHERING PLOUGH SIGNS CONSENT DECREE WITH FDA AGREES TO PAY $500 MILLION
FDA today announced that Schering-Plough Corporation, its subsidiary
Schering-Plough Products, LLC, and two principal corporate officers have
signed a consent decree of permanent injunction agreeing to measures to
assure that the drug products manufactured at the firms' New Jersey and
Puerto Rico plants are made in compliance with FDA's current good
manufacturing practice regulations ("CGMP").
Schering agreed to pay a record five hundred million dollars to the U.S.
Treasury after the consent decree has been entered by the court. This is the
highest monetary settlement in FDA history.
The government sought this money to disgorge profits made by the firms on
drug products that were produced over the last three years prior to entry of
the decree in violation of CGMP regulations. The companies have also agreed
to future monetary payments of up to 175 million dollars and to disgorge
additional profits should it fail to adhere to timelines established in the
decree.
The consent decree will be filed in the U.S. District Court for the District
of New Jersey, and is subject to the approval of the Court.
The government's action in this case follows 13 inspections at four New
Jersey and Puerto Rico facilities since 1998 during which FDA found
significant violations of the CGMP regulations related to facilities,
manufacturing, quality assurance, equipment, laboratories, and packaging and
labeling. The decree requires the companies to pay $471,500 to cover the
costs of these inspections. The defendants have had a history of failing to
comply with CGMP requirements at these plants, which produce about 90
percent of the firm's drug products. The decree affects about 125 different
prescription and over-the-counter drugs produced at the Puerto Rico and New
Jersey facilities. As part of the decree, the company has agreed to suspend
manufacturing 73 other products.
"This action is another clear sign that FDA will continue to enforce the
rules and regulations requiring companies to carefully control and monitor
their processes used to make pharmaceuticals and other products, so that
those products will be safe and effective. Manufacturers who choose to wait
until FDA investigators find violations rather than policing themselves will
find that they have made a poor and costly decision," said Dr. Lester M.
Crawford, FDA's Deputy Commissioner.
To ensure that the firms stay in compliance with CGMP requirements after
entry of the decree, the firms have agreed to submit comprehensive workplans
for each facility for FDA concurrence, station trained personnel at each
facility who will provide full-time oversight of all operations at the
facilities, and have their expert consultants conduct yearly inspections of
the facilities for a period of three years.
For at least five years after entry of the injunction, the companies must
conduct regular audits of its operations and make reports to FDA concerning
its continuing compliance, and FDA will periodically inspect Schering's
manufacturing operations to evaluate the regulatory status of those
operations.
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