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David Kessler, M.D. - Medwatch Health Professionals Meeting

Remarks by
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
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 this
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
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.