New Haven, Conn., Jan. 18, 2006 - Paul R. Pescatello, president and chief executive officer of CURE (Connecticut United for Research Excellence), issued the following statement today in response to the new rule on drug labeling (package inserts) issued today by the U.S. Food and Drug Administration (FDA).

"For years patients have been faced with drug labeling that is overly complex and provides little understandable information about how their medicine should be taken. Even doctors are confused by the labeling, affecting their ability to act in the patient's best interest."

"Today the FDA took a much-needed step to solve this problem by issuing new rules for drug labeling. Among other improvements, the new labeling will include special patient counseling and prescribing highlights. These sections will give patients understandable information that will help them become more knowledgeable about the medicine they are taking, while assisting physicians and reducing medical error."

"An important change is that the new labeling will no longer include the dense legalese describing obscure and rare side effects that is irrelevant to the needs of most patients. Inclusion of this mind-numbing material actually compromises understanding, but many manufacturers have felt obligated to include it in order to ward off potential lawsuits."

"To discourage that practice, the FDA has restated, in the preamble to today's rule, a principle that it has long asserted: that the information included on an FDA-approved label pre-empts product liability lawsuits based on conflicting state laws. This is a fair and reasonable position that will help bring much needed clarity to drug labeling."

CURE (http://www.curenet.org) is a statewide coalition of over 100 educational and research institutions, biotechnology and pharmaceutical companies and other supporting businesses. It is dedicated to promoting the growth and increasing public understanding of biomedical research and science in Connecticut.

available in pdf here.