FDA Publishes New Requirements for E-Labeling of Drug and Biologics Applications
The Food and Drug Administration (FDA) is amending its regulations to require electronic submission of labeling for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), supplements, and annual reports. This new rule is another step in FDA’s efforts to use modern information technology to help inform the public and improve patient safety.
Sponsors will now be required to submit to FDA in electronic format the content of the package insert or professional labeling, including all text, tables, and figures. Labeling content must be submitted electronically in a form described in agency guidance on electronic submissions. This standard format will allow FDA to process, review, archive, and distribute the information publicly. In turn, electronic labeling information will improve the drug labeling review process and speed up the approval and public dissemination of labeling changes, getting important, up-to-date information on medications to doctors and patients more quickly.
“Changes such as this one can make it easier and quicker to ensure that drugs and other products have appropriate labeling information for doctors and patients alike,” HHS Secretary Tommy G. Thompson said. “Across the department, we are committed to putting modern information technologies to work to improve the way we do business and to promote higher-quality care for patients.” The new e-labeling requirement represents an important addition to Secretary Thompson’s “e-health” initiative.
“Using modern information technology to improve public health is no longer optional at FDA,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “With mandatory electronic labeling, FDA will be better able to ensure that information provided by product’s sponsors is accurate, and to communicate information that doctors and patients need in order to use a product. And FDA will be able to get updated information on risks and benefits to the public more quickly as well.”
Until now, the electronic submission initiatives FDA has undertaken have been focused on permitting, but not requiring, applicants to submit required regulatory documents in electronic format. This new regulation for the first time makes such e-submissions mandatory.
It is also an important step in FDA’s larger initiatives involving electronic medical records and electronic health information systems. FDA is currently collaborating with other federal Agencies such as the National Library of Medicine, the pharmaceutical industry, and health care information providers on the DailyMed project to promote patient safety through user-friendly, electronically accessible medication information.
This final rule is intended to supplement existing requirements which stipulate that copies of the label and labeling and specimens of enclosures be submitted. For example, copies of the package insert must still be submitted to FDA in an NDA, and copies submitted to the agency must be identical to the label and labeling and specimens of enclosures that appear in the package insert, on the immediate container, or in any other form distributed. As was the case before this new rule, these copies may be submitted electronically or on paper. FDA’s ability to quickly identify changes in the different versions of labeling, and then make the necessary corrections, would minimize public exposure to any inappropriate labeling.
The rule goes into effect 180 days after it publishes in the Federal Register.