David Kessler, M.D.
Medwatch Health Professionals Meeting
May 4, 1993
Good afternoon. I'm David Kessler, Commissioner of Food and Drugs. Let me also introduce my colleague's: Carol Scheman, Deputy Commissioner for External Affairs and Dr.Stuart Nightingale, Associate Commissioner for Health Affairs, who has arranged this meeting. I'm pleased that all of you could be here today at this important meeting. I want to talk with you about a problem that together I believe we can begin to solve. I'm talking, of course, about postmarket surveillance.
Postmarket surveillance is critical to our job of ensuring the safety of drugs, devices and other FDA-regulated products. There is simply no way that we can anticipate all possible effects of a drug or device during the clinical trials that precede approval. A new drug application, for example, typically includes safety data on several hundred to several thousand patients. If an adverse event occurs in one in 5,000 or even one in 1,000 users, it could be missed in clinical trials. But, it could pose a serious safety problem when the drug is used by many times that number of patients.
That is why it is so crucial to keep an eye on a product once it is in general use. And the health professionals who use the products are indispensable to that process. We need health professionals to report adverse events or product quality problems that may be associated with FDA-regulated products. If there is one message I want to underscore today, it is how important it is for health professionals to take th responsibility seriously, to begin to regard reporting as a fundamental professional and public health responsibility. In that spirit, on June 3rd, I will be announcing MEDWatch, FDA's new Medical Products Reporting Program. It is a program aimed at embedding reporting into the culture of medicine. Make no mistake: These reports have made a difference. I could cite many examples. Let me mention a few. Our finding that a fatal reaction could occur when the antihistamine terfenadine is taken in combination with the anti-fungal medicine ketoconazole or the antibiotic erythromycin began with adverse event reports. So did our alert to health professionals on potentially fatal latex hypersensitivity. And we also ordered a boxed warning and an alert to physicians regarding use of ACE inhibitors during the second and third trimester of pregnancy after conscientious health professionals reported serious problems. The voluntary reporting system also helps FDA identify product quality problems. Problems like defective devices, inaccurate or unreadable product labeling, packaging or product mixup, contamination or stability problems, and particulate matter in injectable products. In 1990, voluntary reporting of these problems resulted in 38 drug recalls. We've even learned about problems with special nutritional products such as medical foods and dietary supplements. For example, this past February, FDA received a report from a medical center concerning a possible link between hyperkalemia observed in two patients in the intensive care unit and two enteral feeding products. FDA followup revealed that some product lines of the manufacturer contained potassium levels of 150 to 250 percent of the declared amount. Because the products are frequently used as a sole source of nutrition, sometimes in patients with compromised renal function, FDA initiated a recall of the product. Yet even though reports from health professionals are critical to protecting the public health, the unfortunate fact is that most practitioners do not think to report adverse events or product problems that might be associated with medications, devices or other products regulated by the FDA. One survey found that barely half of physicians were even aware that FDA had a reporting program. And according to one study, only percent of serious events are reported to the Agency. Meanwhile, up to 11 percent of hospital admissions may be due to drug reactions, one review article concluded.
FDA is committed to doing everything we can to change all this — to facilitate reporting of serious adverse events and product problems. The MEDWatch program has several goals: Make it easier for providers to report. More widely disseminate information to health professionals on FDA's actions that have resulted from reporting. Increase understanding and awareness of drug- and device- induced disease. Make it clear what types of reports the Agency wants — and does not want — to receive. In fact, let me take a minute to talk about that right now. First, FDA does not want reports on every adverse event. This is not practical for the health professional, nor is it useful to FDA. We want those reports in which a health professional suspects that an FDA-regulated product was associated with a serious outcome. Outcomes including death or a life-threatening condition where the patient was at real risk of dying at the time of the event. Where hospitalization is either required in the first place or where a hospital stay is prolonged. When a persistent or substantial disability or incapacity results. Or a congenital anomaly. Or when surgical or medical intervention was required to prevent permanent impairment or damage. Our goal is to increase reporting of these events, not to increase overall reporting.
Already, we have consolidated the separate forms used to report adverse drug and biologic reactions, drug quality product problems, device quality product problems and adverse reactions to medical devices. We published a notice of this draft form in the Federal Register on February 26. Right now we are in the process of refining this form based on the constructive comments we received — including many from those of you here.
This is such an important effort. And it cannot succeed without your help. We need each and every one of you to join with FDA in this effort. The challenge to all of us is enormous. The success of this program, and the FDA's ability to monitor and respond to adverse events and product problems, will depend in large measure on the organizations gathered here today. You can promote the reporting of clinically relevant events. You can help make the reporting second nature to your members. Your members serve as the frontline defense against adverse events and product problems. What can your organization do? Let me tell you what some organizations have already offered to do. In June, the AMA is inserting the new reporting form in every issue of AM News, a publication that goes to more than 400,000 physicians. And it is also publishing an article in JAMA about the program. In addition, the AMA also has agreed to run print ads in its numerous specialty publications encouraging physicians to report and to contact FDA to receive the free reporting kit. The American Society of Hospital Pharmacists has already done an extensive mailing about the June 3 announcement and is running an article about MEDWatch in the June issue of its journal. And the American Nurses Association will distribute information about MEDWatch to state nursing organizations and nursing specialty organizations as well as publish an article in the American Nurse, which goes to 200,000 members.
In responding to the Federal Register notice, several organizations also offered to participate in the educational efforts. For example, the American College of Clinical Pharmacy volunteered to publish the reporting form in its monthly newsletter or its journal, to disseminate information about MEDWatch at its annual meeting, and to develop a jointly sponsored program with FDA in conjunction with one of its meetings. And the American Society of Clinical Pathologists offered to support FDA in developing professional school curricula, to participate in national and regional conferences, and to publish journal articles to increase awareness of medication and device-related injury. We are delighted with this kind of cooperation from these and other organizations. So let me take it the next step and ask you and your organizations to join with us and sign-on to the MEDWatch program. Think about the variety of things you can do to make MEDWatch work. Can your organization make reporting of serious adverse events and product problems an ethical or professional responsibility? What about inserting actual copies of the new reporting form into your journals and newsletters? Or sending a letter from your executive director to all members along with the form urging everyone to report serious adverse events and product problems? How about running print public service ads? Or Incorporating information about MEDWatch into your conferences, continuing education courses, exhibits and publications? FDA is eager to work with you. To cosponsor meetings, co-author articles, co-sign letters to your members. To work with your organizations to reach your members. We need to forge stronger communications links with practicing health professionals. The kind of communication that encourages health professionals to notify FDA — either directly or through the manufacturer — as soon as serious adverse events are suspected. And the kind of communication that allows us to inform health professionals about the actions we have taken as a result of these reports.We need to start now.
Let us take the first step here today by securing your commitment to cooperate with us, each in your own way, cooperating to inform health professionals about the MEDWatch program and the unique role they should play in monitoring medications, devices and other FDA-regulated products marketed in the U.S. Then, on June 3, let us announce your commitment to this program. I hope that that day will mark the beginning of a long-term partnership among FDA, health professionals and industry in monitoring marketed products.
Once again, my thanks for being here today. I look forward to working with you to make MEDWatch a success.