TALK PAPER FOOD AND DRUG ADMINISTRATION U.S. Department of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, Maryland 20857 FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. Talk Papers are not intended for general distribution outside FDA, but all information in them is public, and full texts are releasable upon request. T91-55 Sept. 24, 1991 Food and Drug Administration Data Suggest Association of Connective Tissue Diseases and Collagen FDA has been receiving inquiries from consumers and the media about an FDA has reached the conclusion that available data suggest a higher Collagen, regulated as a medical device under FDA law, is injected under On Aug. 29, scientists from FDA, NIH, CDC and the Texas Dept. of Health reached a consensus that people who have been treated with collagen -MORE Page 2, T91-55, PM/DM injections seem to experience a higher than normal incidence of PM/DM. Additional information regarding the reported cases was subsequently provided by the manufacturer and evaluated by FDA's Center for Devices and Radiological Health. FDA's conclusion about the association between collagen and PM/DM was based on an analysis of the data comparing cases of confirmed or probable PM/DM in the 400,000 people treated with collagen and the number of cases that would otherwise be expected in a similar size population with the same distribution of age, sex and race. FDA indicated that the observed association between collagen injections and PM/DM does not necessarily mean that the injections cause the diseases. The increased number of cases among collagen-treated people could be due to factors such as pre-existing medical conditions, medications or environmental factors. Even if the injections do increase the risk of PM/DM, these diseases are extremely rare and the vast majority of collagen recipients will not develop them. While FDA continues its studies on collagen, the agency has instructed the manufacturer to add a warning to the labels to advise doctors and patients that the incidence of PM/DM is above the expected rate in collagen-treated patients. The agency will also provide for a public airing of these issues. TALK PAPER FOOD AND DRUG ADMINISTRATION U.S. Department of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, Maryland 208: FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. Talk Papers are not intended for general distribution outside FDA, but all information in them is public, and full texts are releasable upon request. T91-68 Susan Cruzan Meeting on Collagen. and Autoimmune Diseases On Oct. 25, FDA convened a scientific meeting to discuss the possible connection between collagen and connective tissue diseases. The scientific meeting was part of FDA's ongoing review of the safety and effectiveness of injectable collagen. The experts noted that there is insufficient statistical or biological FDA's decision to look at the relationship between collagen and these Following further analysis of the reported cases presented at the -MORE Page 2, T91-68, Collagen Meeting rheumatology and connective tissue diseases were asked for their views. The experts noted that limitations in the available data make it difficult to be certain about the causal relationship between collagen and PM/DM. The limitations include the difficulties in diagnosing PM/DM, the possibility that collagen-treated patients were not followed long enough and the rarity of PM/DM. Because PM and DM are so rare, even small changes in certain assumptions, such as the normal rate of PM/DM in the non-exposed population or the number of PM and DM cases among collagen treated patients, can significantly alter the results. Also, it was unclear that a specific biological mechanism could lead to PM/DM. The uncertainty about the association and the lack of a clear biological mechanism do not mean that there is no risk of PM/DM from these injections. In this regard, FDA has informed the manufacturer to add a warning statement to the labeling about the possible association between injections and PM/DM. The agency also suggests that people considering collagen injections ask their doctors for the patient information brochure supplied by the company, which discusses the risks of collagen injections. At least 75,000 people each year receive collagen injections for acne scars and wrinkles. The promotion of Retin-A (tretinoin) for unapproved uses (particularly for the treatment of skin "photoaging") by Ortho Pharmaceuticals, a subsidiary of Johnson & Johnson, was the recent topic of a "60 Minutes" segment. The following chronology summarizes for you FDA's activities over the last two years with respect to this matter: 9/20/89 Prompted in part by a 1/22/88 Washington Post article. uses. FDA letter to Ortho, concerning potential FDA letter to Ortho requesting complete information on the firm's Retin-A activities. at Requested materials provided by Johnson & Johnson. 10/13/89- FDA-Ortho meeting at which FDA acknowledged Ortho's apparent cooperation, including FDA's understanding that ortho had ceased funding promotional programs for Retin-A. 11/6/89 Letter from Congressman Ted Weiss to FDA requesting information on FDA restrictions on the promotion of unapproved uses for approved drugs, specifically RetinA, and referring to a detailed financial and business relationship between Johnson & Johnson and Dr. John - Vorhees, who published an article on Retin-A in JANA. 12/18/89- FDA letter to Ortho concerning scientific/educational/ promotional activities with respect to Retin-A and Pelretin, which is chemically related to Retin-A. Again, the firm responded that it was not involved in promotional activities for these drugs. |