New Physician Labeling to Be Required for Antibiotics

FDA wants to use labeling to combat overuse of systemic antibiotics, which it says increases resistance among microorganisms.



FDA has chosen to combat inappropriate use and overprescription of systemic antibacterial drug products by requiring changes to the professional labeling.

The agency believes that overuse of antibiotics and their synthetic counterparts has caused bacteria to accelerate the development of strains resistant to the medication, making some common illnesses harder to treat than they were even five years ago. Because antimicrobial use "increases the selective pressure on bacteria to develop and spread resistant strains," the agency states, "the more an antibacterial is used, the more likely it is that bacteria will develop resistance."

FDA cites a Centers for Disease Control and Prevention finding that approximately half of the 100 million antibiotic prescriptions written each year are inappropriate, mainly because they are prescribed for viral infections, against which antibiotics are not active.

So, in the September 19, 2000, Federal Register [65 FR:56511­ 56518], the agency proposes a rule to revamp professional labeling to "encourage physicians to prescribe systemic antibacterials more judiciously and only when clinically necessary." It seeks to implement the rule one year after the final version is published.

The proposal would amend 21 CFR part 201 by adding a new section, 201.24, requiring special labeling for systemic drug products indicated to treat a bacterial infection. This new section would:

  • Require the labeling to state, under the product name at the top of the label, that inappropriate use may increase resistant microorganisms and decrease the effectiveness of the drug product and similar products, and that the product should only be used to treat infections proven or strongly suspected to be caused by susceptible microorganisms.
  • Require the "Clinical Pharmacology" section to state that appropriate use includes (where applicable) the identification of the microorganism causing the problem and its susceptibility profile.
  • Require the "Indications and Usage" section to state that initial selection of a treatment should be guided by local epidemiology and susceptibility patterns, and that subsequent susceptibility testing on isolated microorganisms should determine the definitive therapy.
  • Require the "Precautions: General" subsection to reiterate the statements now required under the product name at the top of the label.
  • Require the "Precautions: Information for Patients" subsection to state that patients should be told that the product treats only bacterial, not viral, infections, and that the medication should be taken exactly as directed.


Drugs to treat viruses, fungi, and parasites are not covered under the rule, nor are drugs intended to treat mycobacterial infections, such as tuberculosis or leprosy. Topical antibacterials and antiseptics also are not covered.

The agency estimates that 761 systemic drug products would be affected by the proposed rule. These include aminoglycosides, cephalosporins, chloramphenicols, macrolides, penicillins, quinolines, sulfonamides, sulfones, tetracyclines, urinary anti-infective drugs, miscellaneous antibiotics and anti-infectives, and combination drugs.

FDA estimates each product will incur $2558 in one-time costs for labeling changes and $35 annually thereafter in incremental printing costs. The one-time figure is comprised of $2000 in design and implementation costs and the rest in per-product inventory losses. Though the agency doubts the changes would cause any package inserts to change size, it factored in an annualized cost of printing larger labels at $0.0086 per 100 sq in. and figured an average of 100,000 package inserts per product would be printed each year.

If 761 turns out to be the accurate number of affected products, total one-time costs to industry would be almost $1.95 million, and annualized printing costs would be about $26,000. But the agency also predicts an annual savings of more than $4 million due to fewer hospital infections and shorter hospital stays as a result.

Comments on the proposed rule are being accepted until December 4, 2000. Submit written comments to the Docket Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852.

For further information, contact Gary K. Chikami, Center for Drug Evaluation and Research (HFD-520), Food and Drug Administration, 9201 Corporate Blvd., Rockville, MD 20852, 301/827-2120.

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