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Lester M. Crawford, Jr., D.V.M., Ph.D. - FDA Public Meeting

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

FDA Public Meeting
On Bar Code Labeling For Drugs

Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,
July 26, 2002


I am Dr. Lester Crawford, Deputy Commissioner of the Food and Drug Administration, and it is my great pleasure to welcome you to this public meeting where we will ask for your comments and information to help us decide how to best develop a regulation on bar code labeling for human drugs and biological products, and what should be the scope of such a rule. We will also begin to explore the feasibility of bar coding medical devices

The issue before us goes to the heart of FDA's responsibility to the American people as the agency charged with promotion and protection of the public health. One of FDA's most exacting and critical duties is to make sure that drugs and medical devices that are used to treat our patients are safe as well as effective, and that their benefits outweigh their risks. To meet this requirement, the pharmaceutical and device industries spend millions of dollars on conducting carefully designed and demanding clinical trials. And our agency uses still more resources - including state-of-the art scientific expertise - to submit the results of these trials to a rigorous review.

The mutual goal is to make sure that each drug and device that reaches our market is as safe as it is humanly possible to make it, and we are confident that the products we approve meet that high standard.

Health care products that receive FDA's approval can be relied upon to provide important medical benefits, but they must be properly used. Unfortunately, that is not always the case. Medication errors are a serious public health hazard. Whether they're caused by wrong diagnosis, misread prescription, mistaken dosage, incorrect device use or a poorly followed medication regimen, these errors can invalidate all of the expense, effort, and scientific erudition that had been invested into making the products safe and effective, with tragic consequences for the patient.

Research cited by the Institute of Medicine, three years ago, estimated that up to 100,000 patients die in the United States every year from preventable medical errors in hospitals alone. Medical errors are the eighth leading cause of death in the U.S. - or, as Secretary Thompson has put it, the equivalent of two passenger planes crashing every three days. We believe that 30-50 percent of these deaths are associated with errors involving the use of FDA regulated medical products, drugs, vaccines, blood and blood products, and medical devices.

In addition to the human cost, the economic cost of these errors is staggering. According to some studies preventable morbidity and mortality related to drugs alone increases the Nation's healthcare bill by more than 177 billion dollars a year. Reducing this enormous toll - which exceeds the annual traffic fatalities on our highways - has been a high FDA priority for more than two decades.

These include:

  • Medication guides;
  • Drug and disease-specificEducation campaigns;
  • Improved prescription and over-the-counter label formats;
  • Risk management initiatives;
  • And a review of proposed product names to prevent their mix-up with drugs already on the market.

Today, we will discuss the pros and cons of yet another innovative measure that will help reduce preventable drug-related injuries and deaths, and that is the application of bar coding of human pharmaceutical products, biological products, and medical devices. This is an important initiative that could bring great benefits to the public health, because we know that bar coding can help ensure that the right patient gets the right drug, and the right dose of it, at the right time.

The use of bar coding in several hospitals has shown that the system can significantly diminish medication errors.

For example, we have invited a representative of the Veterans Administration hospital in Chicago, Illinois, to tell us about their experience with a bar coding system that is estimated to have prevented almost 380,000 medication errors in a five-year period.

One hospital in New Hampshire registered an 80 percent reduction in medication errors, and a medical center in Colorado reduced its medication error rate by more than 70 percent -- in both cases, as a result of their use of bar coding.

The health care industry has projected that the use of bar coding across the medical supply chain could result in substantial annual savings. So we are very interested in your views on how a bar coding regulation should work, what it may cost to implement, and how it would affect patient safety.

Peggy Dotzel, FDA's Associate Commissioner for Policy, will be the moderator of today's discussions. In addition, we have other senior managers here from my office and from FDA's Centers for drugs, biological products, and medical devices. We are all eager to hear your thoughts and suggestions on this matter.

Once again, I want to thank you for attending this important meeting, and I hope you'll find today's discussions useful and stimulating. And now, I will turn the proceedings, back over to Peggy Dotzel to begin this morning's session.