Collagen Corp. on Monday objected to what it called "inaccurateand misleading comments" in a report by the House Committeeon Government Operations on issues concerning the FDA andoff-label uses of drugs and devices.

The committee's news release accompanied a report by theHuman Resources and Intergovernmental RelationsSubcommittee, issued last month. That report was the result ofa congressional hearing on June 11, 1991, to address threeproducts -- injectable silicone, Retin-A, and injectable collagen-- as examples of products where the FDA has not acted toprotect the off-label uses of medical products.

According Kirk O'Donnell, spokesman for the Palo Alto, Calif.,company (NASDAQ:CGEN), in Collagen's case the report wentbeyond issues in the hearing and dealt with the safety andefficacy of the company's injectable collagen, which werealready addressed by the FDA.

"The report comes out one-and-a-half years after the hearingand doesn't accurately relate what has taken place since then,"O'Donnell said. "The FDA has done internal reviews of Collagenand has exercised vigorous oversight."

The report ignores the fact that since the hearing the FDA hastwice deemed injectable collagen safe and effective -- after anFDA panel meeting in October 1991 and again last March.

Howard Palefsky, Collagen's president and chief executiveofficer, further noted that the subcommittee's report omittedadditional views in its "Separate and Additional Views" sectionby two Democratic members who stated they had "seriousreservations" about portions of the report dealing with collageninjections.

Collagen also said that Monday's House Committee news releasealso incorrectly stated that "the company has not conductedany long-term research on its patients" even though thecompany has conducted extensive clinical research for itsproducts between 1976 and 1984 pursuant to required pre-market and post market studies.

Regarding issues concerning the unapproved use of injectablecollagen, Collagen had engaged in discussions in 1990 with theFDA about the exact scope of approved uses for injectablecollagen as defined in the original pre-market approvalapplication (PMA), but voluntarily ceased marketing theproduct for lip augmentation in December 1990 and does notcondone the off-label or unapproved use of the product.

Collagen's stock was down $1.50 a share, closing at $22 onMonday, but company spokeswoman Amanda Duckworth saidthat analysts appeared to be "completely unphased" by thenews release.

-- Michelle Slade Associate Editor

(c) 1997 American Health Consultants. All rights reserved.

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