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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Seeks Comment on the Electronic Distribution of Prescribing Information for Prescription Animal Drug Products

October 22, 2007

Announcement of Reopening of Comment Period

The Food and Drug Administration (FDA) today reopened the comment period of the April 2, 2007 Federal Register (FR) notice regarding the electronic distribution of FDA-approved prescribing information currently contained in the package insert (or PI’s) for prescription drug and biological products. Today’s FR notice reopens the comment period for 45 days so that interested persons may submit comments on the concept of electronic distribution of FDA-approved prescribing information currently contained in the PI’s for prescription animal drug products.

FDA is soliciting comments on a number of questions regarding the current use of PI’s for animal drug products, and those logistical issues associated with electronic distribution of such prescribing information for animal drug products. The previous request for comments was limited to human drugs and biologics and was issued in conjunction with an April 27, 2007 public hearing.

As with prescription human drugs, the PI’s with prescribing information accompany prescription animal drugs to meet the requirement that “labeling on or within the package from which the drug is to be dispensed bears adequate information for its use …” (21 CFR 201.105(c)(1)). FDA approves the prescribing information as part of both human and animal drug labeling in the drug application. The request for comment is to gain a better understanding of how PI’s for animal drugs are currently used by animal healthcare providers as we consider new approaches for the dissemination of labeling information.

Currently, the PI contains the prescribing information for the safe and effective use of the product in the form of a paper leaflet. Although the information in the PI is a valuable resource, it is often not readily accessible when a healthcare provider who has not physically received the drug makes a treatment decision or discusses treatments with a patient. Additionally, the PI may not contain the most current information, because the PI accompanying the drug's distribution may have been printed and distributed prior to more recent labeling changes. Accordingly, with technological advances in the electronic transmission of information, the FDA is considering how prescribing information could be more effectively disseminated.

Interested persons may submit written comments on or before December 6, 2007 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Identify all submissions to the docket with the following docket number - 2007N-0114.

For additional information, please contact: Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, Erik.Mettler@fda.hhs.gov.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855