OTHER RELEVANT CHANGES AT THE FOOD AND DRUG ADMINISTRATION AND THE CENTER FOR DRUG EVALUATION AND RESEARCH

Labeling

On November 2, 2005, FDA started requiring that drug manufacturers submit prescription drug label information to FDA in a new electronic format. That was intended to allow patients and healthcare providers to obtain information in FDA-approved package inserts (“labels”) with greater ease (FDA News, 2006c). Drug manufacturers are now required to provide FDA with accurate and up-to-date product and prescribing information in a structured product labeling that can be electronically managed. These labels will be the main source of information for a new interagency Web site, “DailyMed,” a health information clearinghouse, which will provide up-to-date information to consumers and healthcare providers free (National Library of Medicine, 2006).

In January 2006, FDA announced a change in the prescription drug format for the package insert to provide clear and concise information so that healthcare providers can make better use of the drug label to minimize risk and medical errors in their patients (FDA News, 2006c). The final rule was the first revision in 25 years and now requires that prescription information for new and recently approved products meet new criteria. The change was aimed at increasing the readability and accessibility of label information and drawing health professionals and consumers’ attention to the most important pieces of drug information before a product is prescribed. The changes include the insertion of a “highlights” section that includes concise information on the risks and benefits related to the drug, a table of contents in the label, the date of initial approval of the drug, a toll-free number, and Internet reporting information.

The labeling rule also established an important change in statutory interpretation: preempting state product liability laws on the basis of FDA’s approved label. The preamble to the labeling rule states that state laws and judicial decisions that would have the effect of finding FDA-approved labels inadequate or misleading are preempted by the federal rule (21 CFR Parts 201, 314, and 601). That position has partial support in existing case law, and FDA’s assertion of federal preemption under the new labeling rule has not yet been tested in court (National Conference of State Legislatures, 2006).



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