New medicine insert rules effective Friday

June 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: Tuberculosis video game battles world's oldest disease

Related Stories

What is the dark web?

August 13, 2015

The "dark web" is a part of the world wide web that requires special software to access. Once inside, web sites and other services can be accessed through a browser in much the same way as the normal web.

Recommended for you

New Horizons team selects potential Kuiper Belt flyby target

August 29, 2015

NASA has selected the potential next destination for the New Horizons mission to visit after its historic July 14 flyby of the Pluto system. The destination is a small Kuiper Belt object (KBO) known as 2014 MU69 that orbits ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.