FDA Looks To Shield Drug Makers From Liability
"The U.S. Food and Drug Administration, though it has improved a drug labeling regulation through revisions announced today, continues to ignore the fact that its rule will not guarantee patients the most accurate, up-to-date information about their medications, Public Citizen said today.
Further, in an end-run around Congress, the FDA has added to the rule a preamble designed to preempt lawsuits filed by patients under state law, potentially leaving victims of FDA-approved drugs with no remedy for any harm caused by the approved drug.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said revisions in the final version of the rule released today will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they commonly receive patient information leaflets (PILs) that are commercially produced but whose content is not scrutinized by the FDA."
Read more from Public Citizen here.