Collagen

No one disputes the need for a strong FDA to protect consumers (“Report Charges FDA Failure on Wrinkle Products,” Nov. 23). But it is a shame the House Government Operations Committee, in reviewing the FDA in its recently released Human Resources and Intergovernmental Relations Subcommittee report, can’t get the facts straight. It is also a shame that you chose not to research the facts behind the report. The article implies that Collagen Corp. promotes off-label uses of its collagen products and sells products that may be unsafe. These accusations are entirely unfounded.

* The company does not condone the use of or engage in promotion of its devices for unapproved off-label uses. While the company and the FDA have engaged in discussion about the exact scope of approved uses for injectable collagen as defined in the original pre-market approval application, the company voluntarily ceased marketing the product for lip augmentation in December, 1990, before the June, 1991, committee hearing was convened and almost two years before this report was made public.

* The FDA has already re-evaluated the safety and effectiveness of injectable collagen products on two separate occasions. On Oct. 25, 1991, a panel of experts convened by the FDA reviewed the specific issue of the alleged relationship between polymyositis/dermatomyositis (PM/DM) and injectable collagen and concluded that “there is an absence of evidence on both the statistical relationship and a biological basis for believing that there is a relationship,” between injectable collagen treatments and PM/DM. In an unprecedented second review of the Zyderm Implant marketing application conducted in late 1991 and early 1992, the FDA reaffirmed the appropriateness of its original decision.

Finally, one would have thought that a government body would be interested in fair and objective reporting. However, that would have required the news release issued on the committee’s report to mention that two Democratic members stated they had “serious reservations” about portions of the report dealing with collagen injections and that six Republican members stated “the Congress is not a department within a law firm developing research and facts to assist litigants in a court of law.”

HOWARD D. PALEFSKY, President, Collagen Corp., Palo Alto