Regulatory Brief

 Prescription Drugs


Formal title: Docket Number [2007N-0114] Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing; Request for Comments

The Food and Drug Administration, HHS, has reopened the comment period on the electronic distribution of prescribing information for prescription drug products. (Docket No. 2007N-0114)

Brief Description:

The Food and Drug Administration (FDA) reopened the comment period concerning the concept of electronic distribution of FDA-approved prescribing information currently contained in the package insert for prescription animal drug products.

AVMA Response:

The AVMA is appreciative that FDA questioned animal drug needs and reopened the comment period on a previously human health care-centered proposal. The AVMA believes the provision of electronically available, searchable label information including prescribing information is beneficial to veterinary medicine because it increases accessibility to the most current drug information. However, the AVMA does not recommend replacing the paper package inserts with electronically available prescribing information as it would negatively impact animal and public health.

The AVMA also furnished answers to the specific questions posed by FDA in the October 22, 2007 reopening of the comment period.

Background Documents:

View AVMA's response to FDA (PDF)

View Federal Register document (PDF)

Status:

AVMA responded on December 3, 2007