The United States Attorney's Office in San Francisco on Fridayinitiated a seizure of products worth $5 million at CollagenCorp.'s Fremont, Calif., plant.
The Food and Drug Administration said it requested the seizureof 50,770 pre-filled syringes containing Zyderm and Zyplastbecause they were improperly labeled. The collagen-basedproducts are used to smooth wrinkles and scars.
"The firm failed to include a warning on the products' labelingabout the possible link between injectable collagen and a broadrange of connective tissue diseases," the FDA said.
"We were extremely surprised and disappointed that the FDAtook this type of severe action for an inadvertenttypographical error," said Ann Mathieson, director of productmanagement at Collagen. "We didn't know there was a problemuntil the marshal showed up. We learned (what the problemwas) through a press release."
The seizure came the same day that the FDA's orthopedicrehabilitation devices panel unanimously recommendedmarketing approval for Collagen's Collagraft implant. Theimplant, composed of bovine fibrillar collagen and aproprietary ceramic, is designed to assist bone formation atfracture or bone defect sites when combined with the patient'sown bone marrow.
The Palo Alto, Calif., company's stock (NASDAQ:CGEN) lost$4.88 on Friday, closing at $17.63. The company has beenstruggling since mid-June when it, along with three othercompanies, was the subject of congressional hearings onunapproved uses of drugs. Prior to the hearings, Collagen stockwas close to $30.
In February, the FDA approved a labeling change for Zyderm,Zyplast and a related skin test. The new language included awarning to physicians about using collagen products inpatients with systemic connective tissue diseases, includingrheumatoid arthritis, juvenile rheumatoid arthritis andscleroderma. Such patients are more likely to experienceallergic reactions to the injections and less likely to benefitfrom them.
The FDA said that the phrase "systemic connective tissuediseases such as juvenile rheumatoid arthritis" had beenomitted from product labels, "implying that the only diseasesof concern are rheumatoid arthritis and scleroderma."
FDA spokeswoman Susan Cruzan said Collagen had "to bring theproduct back into compliance by relabeling."
Collagen said it will remove the physician package insertsfrom the products and replace them with a corrected version.Mathieson said Collagen had tried unsuccessfully to contactthe FDA on Friday and would try again today.
-- Karen Bernstein BioWorld Staff
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