APUA Letter to FDA
December 1, 2000
Documents Management Branch
(HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Proposed Rule: Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, Federal Register, September 19, 2000
[Docket No. 00N-1463] RIN 0910-AB78
We applaud the FDA for addressing the important issue of antibiotic resistance through the requirements in the proposed rule. We believe that the proposed rule to require additional information on antibiotic resistance will be another step in building public awareness and improving antibiotic use before we have a public health emergency. The following are suggestions to strengthen the FDA's intent and clarify several provisions.
1. We urge that all antibiotics be subject to the labeling requirement. Topicals are sometimes used as an alternative to systemic antibiotics to prevent the emergence of resistance, but resistance can still develop with the use of topicals; likewise for eye and ear infections. See Attachment A for abstracts of eight studies demonstrating this evidence.
2. The proposed rule exempts antibiotics such as Clarithromycin and Rifampin. However, these are used for both mycobacterial and other bacterial infections. Since antibiotics such as these have two purposes, one covered by the proposed rule and the other not, will the pharmaceutical companies be required to put the label in the package insert for these antibiotics? We are concerned that there is some loophole here in which Clarithromycin and Rifampin may not be required to have the additional labeling information. We urge the FDA to clarify how a label will apply in these circumstances.
3. The proposed rule indicates that its purposes are to encourage physicians to use antibiotics more judiciously and for them to counsel their patients to comply with the directions given. It is questionable whether or not prescribers read package inserts thoroughly, due to the length and small type used. We strongly suggest that the FDA, in addition to adopting this rule, send periodic physician advisories to all physicians and other prescribers of medications discussing updates on antibiotic resistance and urging them to use antibiotics prudently.
4. Since patient demand (for antibiotics) often results in physicians prescribing unnecessarily, it is important for patients to learn more about antibiotic resistance. When patients receive the package inserts or a summary of them, we urge that pharmacists include the entire message, not a summary of what is in the package insert, when giving an antibiotic to a patient.
5. We urge the FDA to require that the additional information required on the label be highlighted in a black box to make it stand-out (for all areas - product name, clinical pharmacology, indications and usage, and in both precautions sections - 'general' and 'information for patients'). We further encourage FDA to require in the final rule a print size in the package insert that can be read by all. (Submitted by addendum.)
We would be happy to discuss these issues with you.
Sincerely,
Kathleen T. Young
Executive Director
Cc: Stuart B. Levy, M.D.
Barbara A. Souder, Ph.D.
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