January 21, 2006
New FDA Drug Labeling Guidelines Intended to Preempt State Law
On January 18 the FDA unveiled a major revision to the format for prescription drug information, the package insert, in order to provide healthcare professionals clear and concise prescribing information. The purpose is to manage the risks of medication and reduce medical errors by means of a newly designed package insert that will provide the most up-to-date information in an easy-to-read format intended to draw physician and patient attention the most important aspects of drug information.
The new format is also intended to make prescription drug information more accessible for use with electronic information resources and electronic prescribing tools. This is the first major of the policy in more than twenty-five years. |FDA| The agency also said in a formal policy statement that the guidelines preempt state law. The federal preemption assertion was included in a preamble to the the guidelines and it became immediately controversial. For instance, see also Diedtra Henderson's Boston Globe article from January 19th on this issue.
Preemption of federal drug labeling has been the subject of frequent litigation. For a recent example holding that preemption was inapplicable, see Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726 (D. Minn. 2005). |Lexis|
January 21, 2006 | Permalink
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