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DOW CORNING SAYS FDA ALREADY KNEW THEY HAD GO-AHEAD TO RELEASE DOCUMENTS TO PANEL; ALSO KNEW COMPANY TO RELEASE DOCUMENTS TO PUBLIC

DOW CORNING SAYS FDA ALREADY KNEW THEY HAD GO-AHEAD TO RELEASE DOCUMENTS
 TO PANEL; ALSO KNEW COMPANY TO RELEASE DOCUMENTS TO PUBLIC
 MIDLAND, Mich., Feb. 4 -- Dow Corning confirmed today that the FDA has the authority to release 90 documents concerning silicone breast implants to the FDA panel anytime they choose under an understanding of confidentiality. The company had previously announced that it will release to the general public during the week of Feb. 10 all 90 documents as well as background information on the context in which the documents were created. Of the 90 documents, 80 are nonscientific internal memorandum. Most of the remaining 10 have been with the FDA for some time, and were part of the November panel deliberations when the panel voted to keep the product on the market pending further research.
 Despite Dow Corning's announced actions to release publicly both the documents and their context the week of Feb. 10, the FDA plans to release those documents without their context on Feb. 7.
 "The only difference between our announced scehdule and the FDA's is one weekend," said Barbara S. Carmichael, vice president. "The FDA knew they could forward the documents to the panelists anytime they wanted under an understanding of confidentiality, and they know we're about to release them to the public. It doesn't seem to make sense," she continued.
 The majority of the scientific documents have been with the FDA for some time as part of the original FMAA and part of the original panel hearing. The panel voted in November to keep the products on the market pending further research, some of which is already underway.
 The convening of the same panel a second time to review documents that do not provide additional substantive scientific evidence is unprecedented. Since the panel ruled once, we as well as other manufacturers, many physicians and patients have questioned what appears to be an attempt to obtain a different result.
 "As previously announced, we are releasing these documents to the public the week of Feb. 10. We've been using that time to put them in some context that is meaningful because it's so unusual for documents that are not valid scientific evidence to be part of this process," Carmichael said.
 -0- 2/4/92
 /CONTACT: Barbara S. Carmichael, 517-496-6470, Scott J. Seeburger, 517-496-4078, or Robert J. Grupp, 517-496-6443, all of Dow Corning/ CO: Dow Corning ST: Michigan IN: MTC SU:


KD -- NY105 -- 6944 02/04/92 18:09 EST
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Date:Feb 4, 1992
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