FDA publishes rule on antibiotic resistance labeling

April 1, 2003
Pharmaceutical Representative

The Food and Drug Administration has announced a final rule outlining new labeling regulations designed to help reduce the development of drug-resistant bacteria.

The Food and Drug Administration has announced a final rule outlining new labeling regulations designed to help reduce the development of drug-resistant bacteria. This final rule is aimed at decreasing the inappropriate prescription of antibiotics to children and adults for common ailments such as ear infections and chronic coughs.

According to the Centers for Disease Control and Prevention, half of the 100 million antibiotic prescriptions a year written by office-based physicians in the United States are unnecessary because they are prescribed for the common cold and other viral infections, against which antibiotics are not active.

The new rule applies to all systemically absorbed human antibacterial drugs and requires statements in several places in the physician labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria.

The rule also requires a statement in the labeling encouraging physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed. This is part of ongoing efforts by the FDA to encourage the development of new antimicrobials while preserving the usefulness of existing ones.

Resistant strains

According to the FDA, many bacterial species, including the species that cause pneumonia and other respiratory tract infections, meningitis, and sexually transmitted diseases, are becoming increasingly resistant to the antibacterial drugs used to treat them. Several bacterial species have developed strains that are resistant to every approved antibiotic.

"Antibacterial resistance is a serious and growing public health problem in the United States and worldwide," said Mark McClellan, commissioner of the FDA. "Without effective antibiotic drugs, common infections that were once easily treated can create a serious health threat to children and adults alike." PR