New medicine insert rules effective Friday

Jun 29, 2006

U.S. pharmaceutical companies this Friday will begin using clearer, more understandable package inserts for some of their newer prescription drugs.

While that might be a positive step in improving medication use, some experts worry the change will make it more difficult to sue drug manufacturers for product liability.

The U.S. Food and Drug Administration requirement calls for more concise and better organized patient information package insert sheets. The inserts will include a table of contents, a toll-free number for reporting of adverse drug events, the initial date of FDA product approval and a section that will summarize some of the most important drug information, including benefits, risks and usage.

Assistant Professor of Pharmacy Practice at Wilkes University in Wilkes-Barre, Pa., Dominick Trombetta, says the new rules will help minimize adverse drug reactions and medication errors.

But Trombetta says he is concerned the label changes will make it more difficult to sue drug manufacturers over product liability.

"FDA's response to drug manufacturer's concerns over increased liability was to include wording that would exempt them from state product liability," a decision he says is "extremely disturbing" and which is likely to be challenged in court.

Copyright 2006 by United Press International

Explore further: Researchers synthetize a molecule that opens new pathways for cancer treatment and drug discovery

add to favorites email to friend print save as pdf

Related Stories

Decoding 'sweet codes' that determine protein fates

Sep 15, 2014

We often experience difficulties in identifying the accurate shape of dynamic and fluctuating objects. This is especially the case in the nanoscale world of biomolecules. The research group lead by Professor Koichi Kato of ...

Recommended for you

Discovery helps to spot what makes a good drug

7 minutes ago

(Medical Xpress)—A new test developed by researchers from the University of Manchester could revolutionise the discovery of new prescription drugs. The test will help determine which drugs are unlikely to work at an early ...

New low-cost technique to detect rotavirus

21 minutes ago

Researchers at the Universidad Politécnica de Madrid (UPM) have found a way to enhance detection capacity of small concentrations of rotavirus. All this thanks to a new way to assess the biosensing response ...

Young Aussie women now fatter but fitter

31 minutes ago

Young Australian women are fatter, fitter and more frazzled today than they were nearly 20 years ago, according to Australian Longitudinal Study on Women's Health researchers.

User comments : 0