WASHINGTON -- Centocor Inc. has halted distribution of threein vitro diagnostic test kits for diagnosing and monitoringvarious forms of cancer after being blasted by the Food andDrug Administration for "serious violations of the FederalFood, Drug and Cosmetic Act."
Since the mid-1980s, Centocor has been distributing thediagnostics -- CA 15-3, CA 19-9 and CA 72-4 -- to doctorsunder the FDA's investigational device exemptions. IDE permitssale of certain products to doctors when they are notified thatthe products are to be used for "investigational" purposesrather than actual clinical diagnosis.
In 1985, the FDA charged Centocor with improperly promotingthe tests and won a court judgment in which Centocor wasrequired to sign a consent decree promising to describe theinvestigational status of the kits more clearly to physiciansand to obtain signed letters from users of the kits todemonstrate its compliance with the decree.
On July 1, the FDA sent Centocor a letter charging that thecompany is putting "false, misleading" labels on the kits thatmake them appear to be commercial products. The agency saidCentocor has engaged in widespread distribution of the kits --the company has 7,600 investigators for CA 15-3 and morethan 6,000 investigators for CA 19-9 -- without collectinginvestigational data from the majority of the investigatorsand without having any protocols for controlled studies of thekits.
"This is counter to the spirit and intent of the InvestigationalDevice provisions, and we see it as a subterfuge tocommercially market these devices," said the FDA letter.
In response, Centocor told the FDA it will not submit an IDEapplication for the kits and will continue in-house studies,said FDA spokeswoman Susan Cruzan.
The company is conducting clinical trials in preparation forfiling for a pre-market approval from the FDA for the kits,said Centocor spokeswoman Drew Dorgan.
Centocor's earning statements won't be affected by thewithdrawal of the kits, which accounted for about $2.5 millionin U.S. sales, until the third quarter, Dorgan said.
Centocor stock (NASDAQ:CNTO) lost $1.75 on Thursday, closingat $31.75 after the New England Journal of Medicine publisheda series of letters debating the findings of the company'sclinical studies for Centoxin, a monoclonal antibody fortreatment of gram-negative sepsis.
-- Kris Herbst BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.