If we were only talking about money, it would be bad enough. We are not talking about money; we are talking about the health and lives of American consumers. That is the utmost concern that this subcommittee has. I know that it is the utmost concern of the scientific professionals, who work and have devoted their careers to this agency. I think that the problem that we have had has been at the policymaking level and at the bureaucratic and administrative level. I would like to think that the example that Dr. Kessler has set so far will not only encourage the people within the agency to follow his lead, but that the administration will follow his lead and no longer allow the number crunchers to make judgments as to what kind of moneys can be spent in pursuing the mission that FDA has been mandated by Congress. We will look forward to future appearances by Dr. Kessler. We will be reviewing the transcript to see if we need to have him back in regard to these issues, and then we will so advise him. Again, I want to express my appreciation to him and to all of you for participating. Mr. PAYNE. Mr. Chairman, would you yield for a second? Mr. WEISS. Yes. Mr. PAYNE. I would just also like to indicate to this panel what I did earlier that, in my opinion, the medicine and this whole area of drugs and the whole medical profession, I guess, in general, in my opinion, have not really dealt with women fairly and equally. I say that because in instance after instance we see women excluded from various types of tests with the CDC and NIH. We have seen products sort of pushed a certain way. They use a sensational type of advertising that is almost exploitative. I know that is something beyond your control, but I would hope that somehow the agency could kind of look into this subliminal, subtle situation that, in my opinion, exists, and if there is some way that, creatively, the industry can move toward attempting to eliminate that bias, which seems unfair to me. Like I said, it is rather nebulous point I am bringing out, but I think that if the professionals kind of look closely, you might find that there are threads of sexual discrimination that we find in the whole medical profession. Mr. LEVITT. If I may respond just briefly. For areas that are within FDA's purview, we do have an active women's health initiative ongoing, which some of the details we would be pleased to submit for the record. Mr. PAYNE. All right. Thank you very much. Thank you, Mr. Chairman. Mr. WEISS. Thank you, Mr. Payne. The subcommittee now stands adjourned. Dr. Kessler, of course, as we indicated, is subject to recall, and we will resume, subject to the call of the Chair. Thank you all very much. [Whereupon, at 2:35 p.m., the subcommittee adjourned, to reconvene subject to the call of the Chair.] APPENDIXES APPENDIX 1.-COLLAGEN CORP.'S RESPONSE TO INVITATION TO TESTIFY COLLAGEN CORPORATION June 7, 1991 Chairman Ted Weiss House of Representatives Committee on Governmental Operations B-372 Rayburn Building Dear Chairman Weiss: As our counsel has informed your staff, Collagen Corporation will not be appearing before the Subcommittee to testify on June 11th. We learned that, on a June 6th television broadcast in Boston, a plaintiff in a lawsuit presently pending against the company announced her plans to appear before your Subcommittee next week. Under these circumstances, we do not believe it is appropriate to testify since her claims are being addressed by the courts. Collagen Corporation believes in the strength of its legal position in this lawsuit, which has been demonstrated most recently by another successful verdict in a products liability case in Texas last month. The company intends to continue to vigorously defend its position in the courts. Although I will be unable to appear on June 11th and cannot comment on other products, I would like to provide the Subcommittee with information concerning Collagen Corporation, our policies with respect to promotion for unapproved uses, and a overview of the safety and effectiveness of our products. Collagen Corporation was founded in 1975 by three Palo Alto physicians and a scientist. Their goal in starting the company was to develop biomaterials for medical uses based on the collagen molecule. The insight which the founding doctors of Collagen shared was that the collagen molecule is very similar across species and can be processed to a highly purified state. This material, which in Collagen's case is isolated and purified from bovine hide, can then be used for a variety of applications. In addition, collagen represents a material which is highly compatible in humans and which, unlike silicone or other inert materials, is degraded by normal metabolic processes. Millions of people have benefited from the use of collagen-based hemostatic agents and sutures, standard in surgical practice for several decades. I want to emphasize at the outset that Collagen Corporation has always believed that strong and effective FDA enforcement is one of the most important safeguards to public health in this country, and Collagen welcomes the new FDA Commissioner's commitment to enforcement activities. Collagen firmly believes that its products will continue to meet the most exacting safety standards. Collagen also believes that the concept of strong and effective enforcement must entail better communication between the agency and the companies that it regulates. We have made it a regular practice to keep the FDA informed of our activities, but we recognize that perhaps, in the past, a lack of full and mutual communication has led on occasion to a misunderstanding of FDA's position. We have responded promptly to FDA guidance in the areas of promotion and advertising of our products, as the lip augmentation history described below illustrates, and are hopeful that that sort of guidance and communication will continue in the coming months. Chairman Ted Weiss Page Two Collagen's initial product, Zyderm® I Collagen Implant, was approved as safe and effective for marketing by the Food and Drug Administration in 1981 through the premarket approval (PMA) process for medical devices. This was followed by FDA review and approval of Zyderm® II İmplant, a higher concentration of collagen, and Zyplast® Implant, a cross-linked form of collagen, in 1983 and 1985 respectively. The label indication for Zyderm Implant is "... for the correction of contour deformities of the dermis in non-weight bearing areas." For Zyplast Implant, the label indication is "... for the correction of contour deficiencies of soft tissue." In the late 1980's, the use of injectable collagen to augment lips via implantation into the vermilion (the red portion of the lip) was first publicized by the media through Barbara Hershey's use for the movie "Beaches." This concept for lip augmentation did not originate with Collagen Corporation but with physicians and their patients. We believed (and still do) that this procedure was within the scope of our approved indications. Our view was that if a physician and patient determined that they were dissatisfied with the contour of the patient's lip, this judgment established the presence of a soft tissue contour deficiency or deformity of the type set forth in our approved indications. Therefore, we believed it to be fully appropriate to promote our products for this indication. In a letter dated April 6, 1989 from the FDA's Center for Devices and Radiological Health, Collagen was told by the agency that lip augmentation was not within our products' approved indications. The FDA referred to the cosmetic nature of the treatment, stating that "the [lip] procedure might be performed for cosmetic purposes which many observers would not perceive as being corrections of actual anatomical deficiencies or defects. In such cases, collagen implants would augment an apparently normal contour to gain a presumably more attractive appearance." Collagen responded in a PMA Supplement to the agency dated June 1, 1989 that: Collagen Corporation is firmly committed to training users of our products We went on to say that while we "strongly believe that there is no medical or legal basis for restricting the promotion of our injectable collagen products for lip augmentation," that ... in the interests of working cooperatively with the agency to achieve a Thus, in June 1989, we explicitly informed the FDA, in response to its letter, of precisely how Collagen intended to proceed in view of the agency's stated position. Chairman Ted Weiss June 7, 1991 On November 15, 1990, Collagen received a letter from Mr. Walter Gundaker, Acting Director, Center for Devices and Radiological Health, in which he stated "I believe that Collagen's effort to continue to train physicians and, in fact, use physician 'waivers' is evidence that Collagen is actively promoting the use of this product for an unapproved use." We believe that it would have been somewhat fairer for Mr. Gundaker's letter to have acknowledged that Collagen's position, whether it was right or wrong, had been provided in writing to the FDA. Even so, Collagen Corporation responded in writing to Mr. Gundaker on November 26th and company representatives met with agency personnel on December 3, 1990 in response to Mr. Gundaker's letter. Following that meeting, Collagen promptly agreed that it would "no longer supply the 'waiver' or train physicians in the technique." At this same meeting, and in written communications to the FDA, we described the specifics of our ongoing promotion of injections into the vermilion border of the lip in an attempt to avoid any future misunderstandings between the agency and Collagen. The promotional materials for this application of collagen have also been supplied to the agency. Injections into the vermilion border of the lip have always been within our approved indication, as evidenced by the discussion of overcorrection in this area in the original physician package insert for Zyderm Implant. We believe that we have conducted ourselves responsibly and within the scope of our approved package insert. We believe that our effort to resolve our differences with the agency over its interpretation of the scope of our package insert was appropriate and we believe it to be fully consistent with our stated corporate policy of promoting our products in a manner consistent with their approved labeling. With respect to the issue of safety and effectiveness, our bovine dermal collagen material underwent FDA regulatory approval through the premarket approval (PMA) process rather than securing marketing clearance through section 510(k) premarket notification. We were required to meet the more demanding PMA standards of proof of safety and effectiveness, rather than merely establishing "substantial equivalence" to earlier marketed products as required under the section 510(k) process. The intensive PMA review process includes an independent evaluation of the scientific data supporting safety and effectiveness by an FDA advisory committee of outside scientific experts. To date, over 550,000 persons in the United States and over 760,000 persons worldwide have been treated with injectable collagen. Adverse events associated with the product are primarily local hypersensitivity responses which tend to be mild and self limiting. În rare instances, these responses can be severe enough to result in an abscess. These adverse events are discussed in physician and patient labeling. Collagen requires that a skin test be administered to all patients prior to receiving treatment in order to help eliminate those patients who may respond with a hypersensitivity response. Collagen also makes patient brochures available, which describe in lay terms the risks and benefits from injectable collagen treatments. Despite allegations to the contrary, there are no presently available data to link any systemic disease to the use of our injectable bovine dermal collagen. This is supported by scientific and medical literature as well as various epidemiological evaluations. Collagen believes firmly in the safety of its products and in the legal strength of this position. From a peak of 13 cases brought by plaintiffs alleging a relationship between collagen and the onset of autoimmune disease or "symptoms," Collagen has won ten - including two successful jury trials, one of which was this month -- settled one, and is currently litigating the remaining two. |