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Senior Alert
Eye Drop Maker Threatens to Sue SeniorJournal.com
Over Senior Alert
By Tucker Sutherland,
editor
Jan. 29, 2006 – Jeff Jensen, vice president of MBI
Distributing, an OTC drug manufacturer of eye drops and other products,
has emailed SeniorJournal.com threatening legal action against the Web
site if it does not remove from its site a "Senior Alert" article from
last November that warned seniors about dangers from certain of their
eye drop products based on information from the Food and Drug
Administration.
"This article contains incorrect and slanderous
information," wrote Jensen. "MBI Distributing continues to manufacture
drugs in compliance to FDA manufacturing standards."
The headline of our story published on Nov. 30,
2005 was "Eye Drop Maker Agrees to FDA Order to Stop Manufacturing
Products"
The lead paragraph stated, "The U.S. Food and Drug
Administration (FDA) yesterday announced that MBI Distributing, Inc. (MBI)
has agreed to cease manufacturing and distributing drugs until it
corrects manufacturing deficiencies. Senior citizens should check to see
if they have any of these eye drops - Oxydrops, Bright Eyes, Bright Eyes
II, Clarity Vision for Life, Visitein or Can-C. MBI also makes OTC pain
relieving drugs, including Biogesic, Bio-Ice and Bio-Heat."
The complete original article is available by
clicking here.
"We discontinued the manufacture of our eye drop
products after the FDA ruled they would be considered a new drug,"
Jensen writes.
"We did this voluntarily and immediately. We have
relabeled all OTC pain-relief products to be in compliance with FDA
guidelines. We have not been shut down or required to stop the sale of
any products. We continue to manufacture and sell products in compliance
with our current FDA drug manufacturing license."
The FDA stated in their news release, "This action
is a result of FDA having determined that the firm has been
manufacturing eye drops in a manner that does not conform to FDA's
current good manufacturing practice requirements. The firm has not
corrected violations noted during inspections, despite Agency efforts to
have the company achieve compliance. Among other things, at FDA's most
recent inspection, the firm lacked manufacturing controls to ensure that
its eye drops were sterile."
Jensen concluded with, "We have contacted our
attorneys and notified them of the slanderous material found on your
website. Remove the article within 24 hours or we will file suit for
slander."
We certainly do not want to "slander" any person or
company but feel we only reported the news that was important to our
readers and provided the government agency responsible for monitoring
these products. And, we will certainly consider any news releases the
company wants to provide about changes they have made since this action.
Perhaps the company did, as Mr. Jensen states,
discontinue production of their eye drop products voluntarily.
The FDA says the company signed a consent decree
that requires it to cease manufacturing and distributing drugs until it
corrects manufacturing deficiencies and other violations at its Benicia,
California facility. The consent decree was submitted to the U.S.
District Court for the Eastern District of California by the Department
of Justice on behalf of FDA.
We will let the readers consider the facts and make
their own decisions. We just report the news. If there are any errors in
our report, they were certainly unintentional, and we apologize. The complete news release
by the FDA follows:
FDA News
FOR IMMEDIATE RELEASE
P05-92
November 29, 2005
Manufacturer of Over-the-Counter (OTC) Eye Drops
Signs Consent Decree with FDA
The U.S. Food and Drug Administration (FDA) today
announced that MBI Distributing, Inc. (MBI), also known as Molecular
Biologics, an OTC drug manufacturer of eye drops and other products, has
signed a consent decree that requires it to cease manufacturing and
distributing drugs until it corrects manufacturing deficiencies and
other violations at its Benicia, California facility. The consent decree
was submitted to the U.S. District Court for the Eastern District of
California by the Department of Justice on behalf of FDA and is subject
to approval by the court.
MBI's product line includes eye drops sold under
the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision
for Life, Visitein, and Can-C, as well as several OTC pain relieving
drugs. These products are sold by retailers nationwide.
This action is a result of FDA having determined
that the firm has been manufacturing eye drops in a manner that does not
conform to FDA's current good manufacturing practice requirements. The
firm has not corrected violations noted during inspections, despite
Agency efforts to have the company achieve compliance. Among other
things, at FDA's most recent inspection, the firm lacked manufacturing
controls to ensure that its eye drops were sterile.
FDA has also determined that two of the firm's eye
drop brands, Visitein and Clarity Vision for Life, are unapproved drugs.
In addition, three of the firm's OTC pain relieving drugs, Biogesic,
Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe
use.
Under the terms of the consent decree, MBI is
enjoined from producing and distributing drugs until the firm corrects
the manufacturing violations for its eye drops and its violations of the
marketing approval and labeling requirements of the Federal Food, Drug,
and Cosmetic Act.
The firm's poor manufacturing conditions have
called into question the safety of its eye drops,and the lack of
necessary warnings could undermine the ability of a consumer to safely
use the firm's pain relieving drugs listed above. FDA therefore
recommends that consumers, health care providers, and caregivers dispose
of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life,
Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and
Bio-Heat pain relieving drugs and report any adverse events related to
these products to MedWatch, the FDA's voluntary reporting program at
1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or
online at
www.fda.gov/medwatch/report.htm.
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