E-DRUG: Brand name drug company fined US$ 10 million

Dear friends,

Thought the following news maybe of interest to E-Drug subscribers:

On November 28, 1995, a leading U.S. based brand name drug company
Warner-Lambert agreed to pay US$ 10 million in fines after admitting
that it fraudulently witheld information from the U.S. Food and Drug
Administration (FDA) about manufacturing problems with its popular
antiepileptic drug phenytoin (Dilantin). The company also failed to
report manufacuring problems with three other products. According to
papers filed in the case, batches of some of Warner-Lambert
products including phenytoin failed to meet quality standards.

Meanwhile, the company's ex vice president for quality assurance faces a
maximum sentence of 19 years in prison and US$ 1.25 million in fines for
several charges, including conspiracy and causing the shipment of
adulterated phenytoin.

MORAL OF THE STORY:

Never take for granted that products made by brand name companies always
meet quality standards. Support generic products manufactured by generic
companies which meet GMP standards and thereby use limited resources
efficiently.
                        
Syed Rizwanuddin Ahmad 3831 Beecher St, NW
Researcher Washington, DC 20007-1802, USA
Drug Safety, Education and Information Phone/Fax: 1-202-965-1518