Here's a quiz: The FDA wants to restrict drug makers' ability to change their own labels without approval. Who's upset? A.) the companies, or B.) plaintiffs lawyers? If you answered "A", you're wrong. Drug makers want strict limits for unilateral label revisions. Plaintiffs' lawyers don't.
Here's why: Now, companies have some--or at least a little--leeway in changing the instructions for their meds without the agency's OK. Plaintiffs lawyers use that fact to argue that companies bear the responsbility for warning consumers as new safety concerns become available. Pharma says it's not as easy to make a label change as the lawyers say.
If the FDA tightened up labeling rules even more, then the plaintiffs couldn't lay so much responsibility at the companies' feet. And with all the talk about pre-emption in the air--the idea that FDA-approved products can't face state-court lawsuits--then tighter FDA labeling rules might protect companies even more.
- read the item in the Wall Street Journal Health Blog
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