The US Food and Drug Administration (FDA) is requiring drug manufacturers to provide structured, detailed information on their FDA-approved drugs, which the agency will then make OA on its web site. The new info will use standard terminology for human readability and embedded tags for machine readability. For details, see the FDA press release (November 2):
[T]he 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....In the future, this new product information will also be provided through facts@fda.gov [PS: not yet online], 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....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.
Posted by
Peter Suber at 11/06/2005 12:32:00 PM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
I recommend the OA tracking project (OATP) as the best way to stay on top of new OA developments. You can read the OATP feed on a blog-like web page or subscribe to it by RSS, email, or Twitter. You can also help build the feed by tagging new developments you encounter.
