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: New information about bacterial enzymes to help scientists develop more effective antibiotics, cancer drugs

Related Stories

Researchers design and patent graphene biosensors

November 13, 2015

The Moscow Institute of Physics and Technology (MIPT) is patenting biosensor chips based on graphene, graphene oxide and carbon nanotubes that will improve the analysis of biochemical reactions and accelerate the development ...

A supercomputer for the 'long tail' of science

October 20, 2015

The San Diego Supercomputer Center (SDSC) at the University of California, San Diego this week formally launched "Comet," a new petascale supercomputer designed to transform scientific research by expanding computational ...

The complexity of modeling

November 3, 2015

In recent years, advances in materials synthesis techniques have enabled scientists to produce increasingly complex functional materials with enhanced or novel macroscopic properties. For example, ultra-small core-shell metallic ...

Recommended for you

Moonlighting molecules: Finding new uses for old enzymes

November 27, 2015

A collaboration between the University of Cambridge and MedImmune, the global biologics research and development arm of AstraZeneca, has led researchers to identify a potentially significant new application for a well-known ...

Four pre-Inca tombs found in Peru's Lima

November 27, 2015

Archaeologists in Peru have found four tombs that are more than 1,000 years old in a pyramid-shaped cemetery that now sits in the middle of a residential neighborhood in Lima, experts said.


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.