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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-80
November 2, 2005

Media Inquiries:
Kristen Neese, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Announces the Use of New Electronic Drug Labels to Help Better Inform the Public and Improve Patient Safety

In a continuing effort to use modern information technology to help inform the public and health care providers and to further improve patient safety, the Food and Drug Administration (FDA) today began requiring drug manufacturers to submit prescription drug label information to FDA in a new electronic format. This electronic format will allow healthcare providers and the general public to more easily access the product information found in the FDA-approved package inserts ("labels") for all approved medicines in the United States.

"Providing health care providers and patients with clear, concise information about their prescriptions will help ensure safe use of drugs and better health outcomes," said Health and Human Services Secretary Mike Leavitt. "Now medication information will be easy to access on a publicly available web site, and this will lead to future innovations with health information technology."

These new electronic product labels will be the key element and primary source of medication information for "DailyMed" -- a new interagency online health information clearinghouse that will provide the most up-to-date medication information free to consumers, healthcare providers and healthcare information providers. This information can be accessed through the National Library of Medicine at http://dailymed.nlm.nih.gov. 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.

Under regulations that became effective today, drug manufacturers are now required to submit to FDA prescribing and product information (i.e., the package insert or label) in a structured product labeling (SPL) format that provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format. Using embedded computer tags, the prescribing and product information in the SPL 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.

With this information, physicians will be able to quickly search and access specific information they need before prescribing a treatment, resulting in fewer prescribing errors and better informed decision making. In addition, having the labels submitted to FDA in SPL will improve the FDA drug labeling review process, so that FDA can provide immediate access to the most recent information about medications to doctors and patients.

As FDA receives SPL-formatted labeling information, healthcare professionals, patients, online information providers and other consumers will be able to access the newly updated labels via the Internet, free of charge through the DailyMed system. Updated product labels will be posted on the site within one business day of an approval action by FDA or submission to FDA of a product label change that does not require prior approval.

The DailyMed system was developed in collaboration with federal agencies including: FDA, the National Library of Medicine (NLM), Agency for Healthcare Research and Quality (AHRQ) and the National Cancer Institute (NCI) in the Department of Health and Human Services, and the Veterans Health Administration in the Department of Veteran Affairs (VA) to make the most current medication information available on the Internet free to patients and providers.

"This unprecedented health technology partnership builds a solid foundation for enhanced e-health initiatives to be realized in the very near future," said Acting FDA Commissioner Andrew von Eschenbach. "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."

Within one year, product labels for most approved prescription medications will be posted on Daily Med. The SPL project, led by FDA's Center for Drug Evaluation and Research, is the first in an agency-wide initiative regarding the public provision of electronic information. In the future Daily Med 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 SPL standard, part of the DailyMed project, is one of the initiatives implemented as part of an ongoing collaboration of federal agencies to apply modern principles of information science to translate, repackage and freely distribute up-to-date medication information in a reliable, accurate and consistent format. The group is dedicated to building a nationwide infrastructure for managing medication information to improve healthcare quality in the United States.

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