The Food and Drug Administration (FDA) issued a proposed rule that would require certain labeling submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), supplements, and annual reports to be submitted to the agency in electronic format.
The rule, when finalized, would be the first FDA regulation to require submission of information by electronic means. It would also be FDA's first regulation issued under the President's "e-government" initiative.
"Submitting the content of labeling in electronic format would simplify the drug labeling review process and speed up the approval of labeling changes," said HHS Secretary Tommy G. Thompson. "This is part of the larger effort President Bush has ordered to use electronic data technologies to improve the federal government's efficiency and our service to Americans."
FDA has worked since 1997 to enable submission of information via electronic means, but has not previously required electronic submission. In the proposal, the agency says the electronic format would enable more rapid and accurate review of the content of labeling.
Each year, FDA receives more than 1,000 proposed labeling changes for NDAs and BLAs and more than 2,600 proposed original and supplemental labeling changes for ANDAs. As part of the review process, FDA conducts word-for-word comparisons to ensure accuracy and currency of the information.
"Electronic submissions will allow computer matching that will greatly enhance the accuracy and speed of this part of the review," said Dr. Lester M. Crawford, FDA deputy commissioner.
Other efforts currently underway at HHS to expand efficiency through the use of electronic data technologies include:
E-Grants: An HHS-led, government-wide initiative to reduce paperwork within federal financial assistance programs, focused on making grant application and reporting transactions electronic for both the federal government and grantees.
Centers for Medicare & Medicaid Services (CMS) projects: A variety of Web-based initiatives to assist Medicare consumers who use the Internet, including new interactive databases, a "Q&A" feature, and Web-based decision tools for helping beneficiaries compare their health plan choices.
The National Electronic Disease Surveillance System: A program of the Centers for Disease Control and Prevention to foster public health data sharing and standards development by improving communications among current surveillance systems, which will speed responses to public health threats.
The proposed rule will be published in the May 3 Federal Register with a 90-day comment period. Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be sent to http://www.fda.gov/dockets/ecomments.