Remarks of Carol J. Carmody
Vice-Chairman, National Transportation Safety Board
FDA/NTSB Joint Meeting on Transportation Safety and
Potentially Sedating or Impairing Medications

Washington, DC
November 14, 2001

Good morning. I am Carol Carmody, the Vice-Chairman of the National Transportation Safety Board. Chairman Blakey had planned to be here today, but she is in New York as a result of the crash of AA 587. She sends greetings, and looks forward to the results of the work here over the next two days.

Before we get started this morning, I want to recognize the contributions of several people. First, former NTSB Chairman, Jim Hall, and former FDA Commissioner Dr. Jane Henney who initiated this meeting. The planning has been executed very ably thanks to Dr. Vern Ellingstad of the NTSB and Dr. Stephen Galson of the FDA, who are the co-chairs of this meeting. I also appreciate the attendance and remarks of Dr. Schwetz. I especially appreciate his kind observations about the NTSB: that is the way all of us here feel.

Those of us gathered here today come from different sectors of society, we represent different organizations, with different interests, some of us from different countries--yet, despite these differences, our objective is the same -to ensure the safe travel of our citizens.

Just as we have in the past when faced with a problem, we have come together and worked towards a unified solution. Today, we are looking at an issue that we have known about for years: over-the-counter medicines and prescription drugs contribute to transportation accident. We have made recommendations to address some aspects of the issue. Even so, we have not yet solved it. It is clear that we need to learn a lot more.

Many medicines have long been known to cause drowsiness. Others may impair an individual's ability to fly a plane, drive a car, steer a ship, or operate a train. In fact, recent studies have shown that several over-the-counter medicines and prescription drugs can adversely affect an individual's performance without him or her even knowing it.

Since 1987, the NTSB has investigated over 150 accidents, in all modes of transportation, in which over-the-counter medicines or prescriptions drugs caused or contributed to the accident. In aviation alone, over-the-counter medicines and prescription drugs played a part in 72 fatal accidents between 1987 and 1995. And since 1995, the numbers have been on the rise.

We at the Safety Board believe that the numbers may be even higher. Only a small percentage of people are ever tested for the presence of over-the-counter medicines and prescription drugs following an accident. We believe that more accidents occur as a result of the effects from such medicines.

So, we are faced with a tough question. How do we reduce the number of accidents caused by licit medications when the extent of the problem is unknown? The answer is not simple. We must work together, conduct more research, expand testing programs, and educate the public.

Last year, the Board made a number of recommendations, including expanding current toxicological testing requirements for appropriate samples of fatal transportation accidents to improve our assessment of the actual number of accidents resulting from prescription and over-the-counter medicines. The Board proposes expanding educational programs and providing better warning labels on medications.

All of us here today understand that when education can prevent accidents-it is our collective responsibility to educate those individuals operating our planes, trains, cars, buses and ships.

We should also recognize the efforts to date. The Department of Transportation and its modal administrations, as well as many other organizations represented here today have all taken steps to reduce the number of accidents caused by over-the-counter medicines and prescription drugs.

The NTSB commends these efforts. We all recognize that more must be done. Certainly, none of us would be here today if this were not the case.

Both the NTSB and the FDA appreciate everyone's attendance today, and we look forward to a productive discussion. Ladies and gentlemen, we are one step closer to achieving our common goal.