FDA to list approved products in online archive

The Food and Drug Administration is demanding that manufacturers submit information printed on prescription drug labels in a new electronic format as a step toward building a free online archive of FDA-approved products.

Under regulations effective yesterday, companies must transmit all packaging materials to the FDA in a nonproprietary Extensible Markup Language format known as Structured Product Labeling (SPL). The format will permit easier access to the latest drug data, according to FDA officials.

They also say the streamlined labeling will reduce medical errors.

“Currently, health care providers may be accessing information that is as much as a year out-of-date, thereby impacting the safety of patients,” FDA spokesperson Kristen Neese said yesterday.

SPL-formatted drug labels will become the bread and butter of a new National Library of Medicine Web site, DailyMed, http://dailymed.nlm.nih.gov. In the future, the drug information will also be available at an FDA-hosted Web portal that will serve as a comprehensive source for information about all FDA-regulated products.

Product literature for most regulated prescription medications will be posted on DailyMed within a year, followed by over-the-counter drugs starting in November 2006. FDA officials have not determined when package inserts for vaccines, medical devices, veterinary drugs and food items will be available through the Web site.

The vendor-neutral SPL format uses embedded computer tags to let consumers, health care providers and health care information providers electronically manage and search up-to-date drug label literature. The electronic tags can instruct computers to read specific sections of a drug label, such as product names, indications, dosages, methods of administration, warnings and active and inactive ingredients.

Updates to product labels will be posted within one business day of the FDA’s approval or one business day of their submission to the agency if the change does not require approval.

"The electronic standards established with [SPL] pave the way for future health information innovations in areas such as electronic prescribing and electronic health recordkeeping," acting FDA Commissioner Andrew von Eschenbach said in a press release.

The SPL standard is part of an ongoing federal initiative to translate, repackage and freely distribute up-to-date medication information.

The two new Web sites will be searchable. FDA officials said the sites will not use push technology to feed customized information directly to users.

Companies that make government information accessible and searchable have voiced concerns in the past about agencies offering free customized services such as e-mail updates and personalized settings.


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