WASHINGTON -- Collagen Corp. has initiated measures to fightfallout from a congressional hearing and product litigationrelated to its injectable collagen products.
On Monday, Collagen established an 800 telephone number toanswer questions related to the safety and efficacy of itsproducts. The Palo Alto, Calif., company manufactures implantproducts based on bovine collagen.
Collagen stock (NASDAQ:CGEN) closed Monday at $26.25, up 25cents. The stock fell $3.25 after the hearing last week, closingFriday at $26.
Collagen, along with three other companies, was the subject ofcongressional hearings on unapproved uses of drugs on June 11.Food and Drug Administration Commissioner David A. Kesslertold the human resources and intergovernmental relationssubcommittee that collagen products have "been promoted fora non-approved use, specifically lip augmentation. FDA has notreviewed the safety and effectiveness data for this use."
Collagen has been approved for use on the border of the lip. AnnMathieson, director of product management, said the companywas surprised to be included in the hearing because it hadreached an agreement with the FDA over proper indications inDecember. Collagen Corp. agreed to stop promoting its productsfor augmenting the red portion of the lip.
A litigant in an ongoing product liability suit against thecompany also testified at the hearing. According to Collagen,she alleges that a skin test administered by the companycaused her to contract an autoimmune disease. Following thehearing, Collagen last week issued a statement saying "thereis no currently available evidence linking the use of injectablebovine dermal collagen to the onset of autoimmune diseases."
A spokeswoman said Collagen has successfully defended itselfin two similar product liability cases. She would not predictwhen the current litigation would go to trial.
The public inquiry number is 1-800-327-1179.
-- Steve Usdin BioWorld Washington Bureau
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