Here's a neat and tidy way for drugmakers to avoid those pesky lawsuits -- think Vioxx -- that hold them liable for all the harmful drugs they bring to market: Have the government agency that "regulates" them declare federally approved drug labels pre-empt state law.
This unconscionable proposal, written into the fine print of new FDA rules, could help drugmakers argue in the courts they weren't required to warn consumers about potential problems or safety issues not included on a federally-approved label, according to this awesome Wall Street Journal piece (rare free text link below).
The real kicker: For these protections to apply, drug companies must provide all pertinent data to the FDA, which certainly didn't happen in the Vioxx debacle.
The good news, if there's any to be found here, is the courts have ruled federally mandated labels are minimum standards, and aren't always protected by law. The announcement also caught state governments by surprise, spurring comments the agency is encroaching on their laws.
All the more reason, you can't expect the FDA, as it's currently configured, to protect you from harm.
Wall Street Journal January 14, 2006 Full Free Text Article