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The U.S. Food and Drug Administration
(FDA) announced the entry of a Consent Decree of Permanent
Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two
company officials, Mark Tengler, PharmaFab's president, and Russ
McMahen, PFab's vice president of scientific affairs, to stop the
illegal manufacture and distribution of prescription and
over-the-counter drug products. The products are illegal because
they are not produced according to the required current good
manufacturing practice (CGMP) and many also lack required FDA
approval. The case was filed in the United States District Court for
the Northern District of Texas.
“Drug approval and CGMP compliance are part of the foundation of
drug safety,” said Steven K. Galson, M.D., M.P.H, director of FDA's
Center for Drug Evaluation and Research (CDER). “When companies and
individuals choose not to comply with the law, FDA must deal with
these problems decisively.”
PharmaFab is a major contract manufacturer and distributor of
more than 100 different prescription and over-the-counter drug
products, including cough and cold products, ulcer treatments, and
postpartum hemorrhage products. Consumers who have products
manufactured by PharmaFab should consult with their physician.
The unapproved drugs manufactured by PharmaFab include, but are
not limited to:
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De-Congestine
Sustained Release Capsules;
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GFN 1200/DM 60/PSE 60
Extended-Release Tablets;
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Rhinacon A Tablets;
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Sudal 12 Chewable
Tablets;
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Histex PD 12
Suspension;
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Atuss HX CIII;
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Ergotrate Tablets;
and Hyoscyamine Sulfate Time-Release Capsules.
Because these drugs have not undergone FDA approval, their safety
and effectiveness have not
been established, and FDA has not reviewed the adequacy and accuracy
of the directions and
warnings in their labeling.
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According to the complaint filed with
the court, PharmaFab did not comply with CGMP by not investigating
manufacturing failures and not recording and justifying why it
deviated from written manufacturing procedures. Further, the company
lacked an effective quality control unit and failed to establish
reliable expiration dates for products. Compliance with CGMP is
necessary to ensure that drugs have the requisite safety, identity,
strength, quality, and purity.
The consent decree requires the defendants to destroy certain
illegal drugs, and bars them from distributing all drugs until they
obtain required FDA approval and fully comply with CGMP. If they
resume distributing drugs, the defendants are required to retain an
auditor to conduct inspections of their facilities for a period of
five years and to provide reports to FDA analyzing compliance with
CGMP and labeling requirements. The decree also allows FDA to
require recall or shutdown in the event of future violations and
provides for damages of $5,000 per day and $1,000 per violation, up
to a maximum of $5 million per year, if the defendants fail to
comply with its terms.
“FDA will not hesitate to pursue enforcement action when
necessary,” said Margaret O'K. Glavin, FDA's associate commissioner
for regulatory affairs. “We will continue to protect public health
by carefully monitoring the provisions of this injunction. FDA will
also continue to investigate and take action against other marketers
of unapproved drugs.”
In June 2006, FDA issued a guidance document entitled, “Marketed
Unapproved Drugs—Compliance Policy Guide” (CPG). The CPG makes clear
that firms may not market drugs that require approval without first
establishing in applications that the products are safe and
effective. One of the priorities in this CPG is enforcement actions
against manufacturers that violate other provisions of the Federal
Food, Drug, and Cosmetic Act.
For more information:
FDA's ongoing efforts on marketing unapproved drugs
www.fda.gov/cder/drug/unapproved_drugs
CDER's Web page on Compliance with Current Good Manufacturing
Practices
www.fda.gov/cder/dmpq/.
[Text copied
from U.S. Food and Drug Administration
news release] |
