Attention

The opinions expressed by columnists are their own and do not represent our advertisers

Friday, June 24, 2011

Makers Of Generic Drugs Don't Have To Warn Of New Dangers, Supreme Court Rules

Washington - The Supreme Court gave the pharmaceutical industry a pair of victories Thursday, shielding the makers of generic drugs from most lawsuits by injured patients and declaring that drug makers had a free-speech right to buy private prescription records to boost their sales pitches to doctors.

In both decisions, the court's conservative bloc formed the majority, and most of its liberals dissented.
About 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the original makers of these brand-name drugs to include an approved and up-to-date warning label that tells doctors and patients of possible side effects or complications.

But in a 5-4 decision, the high court said this duty to warn patients of newly revealed dangers does not extend to the makers of generic drugs. Justice Clarence Thomas said that because the federal Food and Drug Administration must approve changes in the warning labels, the generic makers may not be sued under state liability laws for failing to warn patients of new dangers.

"We find impossibility here," Thomas said, because the federal regulatory law and the state liability law are in conflict. The dissenters said the generic drug makers should notify the FDA and its patients as soon as it receives reports of serious new problems.

No comments: