Forest Labs Inc. Warned by FDA on Drug Study Process (Correct)
Bloomberg News
March 24, 1999, 11:08 a.m. ET
Forest Labs Inc. Warned by FDA on Drug Study Process (Correct)
(Corrects nature of the studies referred to in the FDA
warning, adds information on the version of Celexa mentioned in
the warning letter)
Washington, March 24 (Bloomberg) -- Forest Laboratories
Inc., a maker of brand-name and generic drugs, failed to properly
assess the accuracy of drug concentrations in the human
bloodstream during laboratory tests, the U.S. Food and Drug
Administration said in a warning letter.
The tests involved drugs including an experimental liquid
form of the company's antidepressant Celexa.
According to the FDA, the company improperly monitored
quality control on studies conducted at its Farmingdale, New York
facility, where the concentration of drug ingredients in human
volunteers is tested.
The warning letter concentrated on ''an intellectual
disagreement on our standards,'' said Lawrence Olanoff, Forest's
executive vice president for scientific affairs.
In a company statement, Forest said ''none of the comments
made by the FDA affects the validity of data that supports the
potency, safety or efficacy of our marketed products.''
Among the seven studies the FDA said it examined during an
October 1998 inspection were two for use in the approval process
for a new liquid form of Celexa. The company currently sells
Celexa in a tablet form with Warner-Lambert Co. The liquid
version hasn't yet been approved and isn't on the market.
Celexa competes with the No. 1 antidepressant, Eli Lilly &
Co.'s Prozac, and SmithKline Beecham Plc's Paxil.
In the inspection of the studies, the FDA said it found
evidence that Forest didn't use proper standards to assess the
purity of the solutions used in the studies, which also led to
inaccurate data.
Tests ''that do not meet the (quality control) acceptance
criteria should be rejected,'' said the letter, issued March 12
and released today the agency's Freedom of Information office.
The FDA said continued problems with the studies could
prompt the agency to reject future studies from the company. The
company has until April 5 to respond to the violations spelled
out in the letter.
The FDA also examined tests for the asthma drug flunisolide,
the anti-flu drug rimantadine and isosorbide dinitrate, a widely
available generic drug used to treat chest pain caused by heart
attacks.
The FDA sends hundreds of warning letters to companies each
year, and only a small handful of them result in significant
agency action. Still, the letters can be the last notice before
the FDA takes steps such as holding up shipments of products or
pursuing civil fines.
-- Brian Reid in Washington (202) 624-1936 and Michelle Fay
Cortez in Minneapolis / mfr |
