CONGRESS
07/10/1991

Inappropriate Promotion of Drugs and Devices

STATEMENT BY DAVID A. KESSLER, M.D.
COMMISSIONER OF FOOD AND DRUGS
PUBLIC HEALTH SERVICE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS
U.S. HOUSE OF REPRESENTATIVES

June 11, 1991

Mr. Chairman and Members of the Subcommittee:

I appreciate the opportunity to appear before you this afternoon. It was important for me personally to come because I care deeply about inappropriate promotion of drugs and devices. As your staff knows, I have a longstanding commitment at 2:00 o'clock this afternoon and I will need to excuse myself at 1:45.

Mr. Chairman, I am here today to deliver a strong message to consumers and physicians that, in general, new drugs and devices not approved for any use are illegal. Furthermore, the promotion of an unapproved product, including the promotion of an unapproved use of an approved product, is also illegal. Such activities may pose significant dangers to patients. Be assured that the full force of the statute will be mustered to deal with such practices. My job today is to warn the American public and the medical profession about several illegal practices without getting into the details of pending FDA investigations. Let me assure you, Mr. Chairman, that the will of the Agency to use its enforcement tools is there.

I will not hesitate to take strong enforcement actions under the Food, Drug and Cosmetic Act. These include seizure, injunction, and prosecution, and, additionally, for medical devices, administrative detention and civil penalties.

Liquid silicone for injection, which is used to remove wrinkles and other facial deformities, has not been approved by this agency. No use of silicone for injection has been approved. This product is illegal and its use must stop. No application has been approved for this product. Consumers should know that the safety and effectiveness of this product have never been fully evaluated and, therefore, consumers are exposing themselves to unknown risks. The medical literature has discussed some of the risky results; such as swelling, reddening of the skin, lumpiness of the face, or the development of soft tissue tumors.

We cannot even assure consumers about the composition of the material being injected. There is no standard product. Furthermore, there is no authorization of this product for investigational cosmetic use. The only experimental use currently approved for study is for ophthalmic use. In the case of liquid silicone for injection, the sale, shipment, distribution, manufacture, use and promotion are illegal. Make no mistake about it: injection with liquid silicone - a product that has not been scientifically evaluated - may be dangerous.

Let me move on to the injection of collagen for cosmetic purposes. Collagen has been approved for certain specific uses. What is clearly illegal, with respect to collagen, is its promotion for unapproved uses. I am aware that collagen has been promoted for a non-approved use, specifically lip augmentation. FDA has not reviewed the safety and effectiveness data for this use. Consumers should recognize that the use of collagen for lip augmentation has not been shown to be safe or effective. Consumers should not undergo lip augmentation procedures with Collagen.

Regarding the promotion of collagen for lip augmentation, we contacted the company when we learned of this activity. They disagreed with us about the scope of corrections around the lip that could be made under the approved indications. Nevertheless, we informed the company that its promotion for lip augmentation was in violation of federal law. The company agreed to stop promoting this unapproved use. Our recent follow-up investigation indicates the firm has modified its practice. FDA will continue to assess the firm's compliance with this and other regulatory requirements. I can assure you, Mr. Chairman, that we will continue to be vigilant about this product and any promotion for its unapproved uses.

Collagen's first approval in 1981 was based on effectiveness information for acne scars. Collagen is now more frequently used to treat age lines or wrinkles. We lack effectiveness data for that indication. Under the authority of the Safe Medical Devices Act of 1990 FDA will order information from collagen manufacturers regarding its changing patterns of use.

Let me move on to a third product, the use of Retin-A to prevent wrinkling. Retin-A is approved for use in acne vulgaris. Its use to prevent wrinkles is an unapproved use. We do not have data to assess the long-term safety of Retin-A for chronic use for wrinkling. One of our concerns, for example, is that Retin-A is a photosensitizer which, if used chronically, could potentially increase the risk of skin cancer. This, as well as other possible risks, remains to be fully evaluated. Indeed, the current labeling on Retin-A specifically states that the long-term safety and effectiveness of Retin-A has not been established for any use other than severe acne.

Let me make an additional point, Mr. Chairman. Long-standing FDA policy permits a physician to make a decision whether to use an approved drug for uses beyond the labeling. However, the law is clear that the promotion of such uses is illegal. Physicians may not, under the guise of scientific exchange, participate in the manufacturer's promotion of unapproved uses.

Let me say to the medical community that we will subject not only the manufacturers, but all those involved in the manufacturer's promotion, to the full force of the law.

Furthermore, let me warn physicians about the unapproved use of one more agent, calcium channel blockers. These drugs have been approved for and are appropriately used to treat angina and hypertension. Calcium channel blockers have, however, been inappropriately promoted for an unapproved use -- to improve the survival of patients recovering from heart attacks.

The manufacturers of these products have encouraged physicians to substitute calcium channel blockers for beta blockers, a class of drugs that have been shown to improve survival in certain patients who have suffered heart attacks. In contrast, the well-controlled clinical trials that have addressed the use of calcium channel blockers in post-heart attack patients have not shown a beneficial effect on their survival. Of considerable importance, post-heart attack patients with pulmonary congestion who were given calcium channel blockers showed a decrease in survival compared to those patients given a placebo. FDA will not permit manufacturers to claim that calcium channel blockers improve survival after a heart attack. Let me restate that these drugs have appropriate uses in angina and hypertension. It is the inappropriate promotion of these drugs that we are concerned about.

Since becoming Commissioner of FDA, I have made abuses in prescription drug promotion an enforcement priority. I am committed to seeking out violations of the statutory and regulatory requirements applicable to drug promotion and to imposing meaningful penalties. To assist FDA in this effort, I have authorized a significant increase in the size of the staff that regulates promotional activities for prescription drugs. Although I will not discuss specific enforcement actions that are underway, I strongly support the use of court actions and other remedial measures against companies which engage in illegal promotional activities.

We also intend to identify promotional activities that are disguised as education or public relations and hold these activities to the same standards as traditional promotional techniques. FDA recently took action against the publication of an apparently independent scientific journal which reported on the unapproved uses of various oncology products. The journal was in fact sponsored by the manufacturer of the products that were discussed favorably in the journal, and FDA informed the manufacturer that the journal would be considered promotional. FDA has reached an agreement with the manufacturer of those drugs, under which the company will cease publication of the journal, mail a letter to all physicians who received the journal admitting the firm's sponsorship, and submit to FDA for preclearance all of its oncology promotional materials for two years.

The long-term success of FDA's efforts to eliminate promotional abuses in the pharmaceutical industry will depend, in part, on our ability to train practicing physicians and medical students to recognize misleading promotional activities, especially those disguised as research or medical education. In addition, physicians represent an important, currently untapped, source of information about forms of promotion that are difficult for FDA to monitor, such as detailing activities. I am therefore initiating a new program intended to inform physicians and medical students about FDA's regulation of drug promotion and to enlist their support in reporting improper or misleading promotional campaigns.

I believe this is as critically important an issue for the other FDA centers as it is for our drug center, and I formed a working group to conduct an Agency-wide review of product advertising.

This review will examine, in particular, how to construct a springboard for action against the inappropriate promotion of medical devices. While this is underway, we intend to act against instances of clearly violative behavior, whether by manufacturers or health care professionals, which present a public health hazard.

I believe all these efforts will go a long way toward identifying problems and developing approaches to solving them. We need to stop the escalation of inappropriate promotional activities and make sure that consumers, as well as health professionals, are not misled.

Mr. Chairman, that concludes my formal statement. My colleagues and I will be happy to answer questions.