Because of the potential risks, it is illegal for the manufacturer to advertise or promote the "off-label" use of a drug or device. However, it is legal to provide funding for scientific research and talks at medical conferences, since those are considered educational activities. Sharing of scientific information is an important part of health care. However, when the information is presented by researchers who are paid spokespersons for the manufacturer, the dividing line between promotion and education starts to dissolve. The line may disappear entirely when those paid spokesmen are interviewed in newspapers and on TV. Unfortunately, for years the FDA has not clearly defined or rigorously enforced the prohibition against the promotion of drugs and devices for unapproved uses. As a result, pharmaceutical companies routinely pay for advertisements and promotions that are disguised as medical journals, information videos, or scientific conferences. Public relations firms are used as conduits for money provided to university scientists, who then promote drugs at press conferences, on TV talk shows, and at interviews with journalists. All these activities are really promotions under the guise of "sharing information." Today's hearing will focus on several examples of prescription drugs and medical devices that are promoted for uses that are not approved by the FDA. For example, Retin-A is approved for acne but is now widely used for wrinkles and precancerous skin conditions. It has not been proven safe or effective for either. Silicone injections have been considered not safe or effective for humans for more than 20 years, but continue to be used for breast augmentation and, more recently, for wrinkles and lip enlargement. Collagen injections are approved for treating wrinkles and acne scars but not for the lip enlargements that are the current fad. All of these drugs and devices are widely available because they are approved for other uses. Although we are focusing on three examples, the issues we will discuss are relevant to hundreds if not thousands of drugs and devices. At today's hearing, we will attempt to answer the following questions: One, what are the risks associated with the off-label use of RetinA, injectable silicone, and collagen? Two, is FDA adequately regulating promotion of these drugs and devices for unapproved uses? Three, should FDA be given enhanced powers and resources to investigate and penalize companies for the promotion of their products for unapproved uses? Before introducing our first panel, let me enter into the record the opening statement of Congressman Craig Thomas, who has an Interior Committee hearing today that is very important to his State and to his district, without objection. [The prepared statement of Mr. Thomas follows:] CRAIG THOMAS Congress of the United States Washington, DC 20515 WASHINGTON OFFICE: 1721 LONGWORTH HOUSE OFFICE BUILDING WASHINGTON, DC 20515 (202) 225-2311 OPENING STATEMENT FOR CONGRESSMAN CRAIG THOMAS (WY-AL) HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE June 11, 1991 MR. CHAIRMAN, I want to thank you for holding this hearing this morning. Oversight of the activities of the Food and Drug Administration is one of our more important duties on this Subcommittee, and this is an issue that merits our consideration. FDA has one of the most important responsibilities of this government to ensure the safety and efficacy of all drugs and medical devices used in this country. FDA is responsible for evaluating all new drug and device applications, conducting clinical studies on these products, approving them for specific uses, and, finally, ensuring that the producers label and promote only for those approved uses. It is the last responsibility that brings us here today. There are two questions before this Subcommittee. The first is whether or not certain drugs are being used for non-approved purposes. As all of our witnesses will agree, the clear answer to that question is "yes." Retin-A and Collagen have only been approved for limited purposes, but have been widely prescribed for other uses. Liquid silicone injections have never been approved by FDA, and its continued use presents the agency, the Congress, the medical community and the general public with serious legal and ethical problems. The second question is the scope of FDA's rights and responsibilities to monitor and act upon these problems. The law is clear that FDA is limited to oversight of companies that produce and promote these drugs and devices. The law is equally clear that unless a clear and present danger to the public exists, FDA is extremely limited in its efforts to enforce sanctions on physicians for non-approved use of these products. The The first panel of witnesses will show that these are not questions asked to stimulate interesting arguments. consequences are real, and there are victims when these incidents occur. We are all sorry that these individuals have had to experience the problems they will detail for us today. The sole responsibility of this subcommittee is to look at the actions of FDA, and to ensure that they acted within, and conformed to, all the laws and regulations that affect these decisions. FDA can determine specific uses for the drugs and devices, and it can dictate how the producers can promote the products. FDA can not interfere in the private practice of medicine between doctor and patient. Throughout the course of today's proceedings, it can not be overlooked that physicians have a responsibility in this situation. Liquid silicone injections have never been approved by FDA, yet it is still used in many places around this country. There are even examples of physicians thwarting FDA's attempts to stop it. Other physicians actively use and promote Retin-A and Collagen for purposes they know have not received approval. FDA bashing should not be used as a convenient way to avoid placing actively find ways to skirt FDA rulings. The question before us is not whether a problem exists...it clearly does. The question is whether or not FDA has met its responsibilities and obligations under the law. I look forward to the testimony of all of our witnesses today, and thank the Chairman again for holding this hearing. Mr. WEISS. Let me now call on my distinguished colleague from New Jersey, Mr. Payne. Mr. PAYNE. Thank you very much, Mr. Chairman. Let me commend you for calling this hearing today to focus on the protection of the public from unapproved uses of drugs and medical devices. Although this is not the first time we have convened to examine the mechanisms available to the FDA to ensure that the public receives information and protection, I am no less concerned by the issue at hand. All too often, men and women opt for cosmetic surgery or medications without fully realizing the dangers of the drugs or medical devices. It appears that the public can unwittingly choose procedures and medications which are more harmful than helpful to their health. I want to welcome all the witnesses today, and I look forward to hearing the first-hand observations and the suggestions for further improvement in the efficacy and the implementation of the FDA regulatory structure. Thank you, Mr. Chairman. Mr. WEISS. Thank you very much, Mr. Payne. We will be entering other statements into the record, without objection, and other documents, as we proceed. Our first panel will consist of Ms. Nancy Meader of Saunderstown, RI; Ms. Laurie Lehman of Palo Alto, CA; and Ms. Jane King, of Plainville, MA. If you would take your places behind the chairs where your name plates appear. It is the custom of the Government Operations Committee that all witnesses appearing before the committee will be sworn in, and so if you would, please raise your right hands. [Witnesses sworn.] Mr. WEISS. Thank you. Let the record indicate that each of the witnesses has replied in the affirmative. Before we begin, let me say to all of you that the full text of your written statements will be inserted into the hearing record. We have asked each of you to summarize your testimony in 5 or 6 minutes, so that there will be time for questions after each panel presentation. I want to thank you at the outset for your willingness to participate in today's hearings. I know that it is not necessarily easy or comfortable to do so. We will ask each of you testify, and we will have questions when all of you have completed your prepared testimony. If I make an error in pronouncing your names, please correct me. Ms. Meader, we will begin with you. STATEMENT OF NANCY MEADER, SAUNDERSTOWN, RI Ms. MEADER. Thank you. Mr. Chairman, members of the subcommittee, my name is Nancy Meader. Mr. WEISS. Will you pull that microphone closer to you? It is not very sensitive. Just speak right into it. Ms. MEADER. I am here to testify about an adverse reaction I had to the Retin-A drug. |