FDA requires standardized e-labels from drug makers

The Food and Drug Administration is now requiring pharmaceutical manufacturers to submit prescription drug label information to the agency in a new, electronic format.

Under regulations that became effective yesterday, drug makers must submit to the agency prescribing and product information, such as the package insert or label, in a structured format that provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format.

The electronic format should result in fewer prescribing errors and better informed treatment decisions, because physicians will be able to quickly search and access specific information about medications.

Through the use of embedded computer tags, the prescribing and product information in the structured labeling format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label, including product names, indications, dosage and administration, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied.

"The electronic standards established with structured product labeling pave the way for future health information innovations in areas, such as electronic prescribing and electronic health record keeping, that can transform the way we gather, use and share medication information from bench to bedside," said acting FDA Commissioner Andrew von Eschenbach.

The new electronic product labels will be the primary source of medication information for DailyMed, a new interagency online health information clearinghouse accessed through the National Library of Medicine.

In the future, this new product information will also be provided through facts@fda.gov, a comprehensive Internet resource designed to give one-stop access for information about all FDA-regulated products.

The electronic format also should improve the FDA drug labeling review process so that the agency can provide immediate access to the most recent information about medications to doctors and patients. As FDA receives structured product labeling-formatted information, health care professionals and consumers will be able to access the newly updated labels via the Internet through the DailyMed system.

Updated product labels will be posted on the site within one business day of an approval action by the FDA or submission to the agency of a product label change that does not require prior approval.

Within one year, product labels for most approved prescription medications will be posted on DailyMed. The SPL project, led by the FDA's Center for Drug Evaluation and Research, is the first in an agencywide initiative regarding the public provision of electronic information. In the future, DailyMed will also include labels for biologics such as vaccines, medical devices, veterinary drugs and some food products. The agency expects to launch additional components of the facts@fda.gov Internet resource early next year.

The DailyMed system is a collaboration between FDA, the National Library of Medicine, the Agency for Healthcare Research and Quality, and the National Cancer Institute, all agencies of the Health and Human Services Department, as well as the Veterans Health Administration in the Veterans Affairs Department.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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