HHS NEWS • U.S. Department of Health and Human Services

P00-18 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Print Media: 301-827-6242 / Broadcast Media: 301-827-3434

FDA LABELING REQUIREMENTS FOR SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS INTENDED FOR HUMAN USE

November 9, 2001 -- FDA today proposed that all systemic antibacterial drug products intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. Over-prescribing and inappropriate use of antibiotics have contributed to a dramatic increase in drug-resistant bacterial infections.

The proposal is intended to encourage physicians to prescribe systemic antibiotics only when clinically necessary. It also encourages physicians to counsel their patients on the importance of taking them exactly as directed.

"Antibiotic resistance is a serious and growing public health concern in the United States and the world," said Dr. Jane Henney, Commissioner of Food and Drugs. "When we avoid the unnecessary use of antibiotics, we help preserve their effectiveness."

Many bacteria, such as those that cause pneumonia and other respiratory infections, meningitis, and sexually transmitted diseases, are becoming increasingly resistant to antibiotics used to treat them. Several bacterial species have developed strains that are resistant to multiple anti-microbial drugs.

An important component of a comprehensive program to address the problem of bacterial resistance is decreasing the unnecessary use of antibacterial drugs. FDA is proposing to require that the labeling for systemic antibacterial drug products include certain statements about the inappropriate use of antimicrobials and the link between inappropriate use and the emergence of drug-resistant bacterial strains.

Under the proposal the labeling would state that the following reminders for physicians:

*Antibacterial drugs should only be used in situations where a bacterial infection is either proven or strongly suspected. Anti-bacterials do not treat viral infections.
*The type of bacteria involved in an illness and its antimicrobial susceptibility pattern should be used to direct the initial choice of an antibacterial.
*Antimicrobial therapy should be modified once microbiologic results are available.
*Patients should be counseled about the proper use of antibacterials and the importance of taking them only as directed. A final rule based on this proposal would become effective one year after the date of its publication in the Federal Register. After that date, all systemic antibacterial new drugs and generic drugs (including drugs that have already been approved and are currently on the market) would have to comply with the labeling requirements.

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