This morning, the FDA proposed a stricter rule about allowing drugmakers to simply change the labeling on their meds without agency approval (look here). Currently, drugmakers have some latitude. On the surface, that may seem like a good thing, because a drugmaker in possession of important safety info, for instance, can act without having to wait for the agency to sign off.

But this has proven to be a double-edged sword for pharma. That’s because plaintiffs’ attorneys argue that if a drugmaker can update labeling at its own discretion, the drugmaker is responsible for warning consumers about new safety info. So the FDA’s stricter proposal is a welcome step, because product-liability lawsuits regularly charge this or that drugmaker with failing to do enough to warn consumers about some side effect issue.

This is where preemption comes in. Pharma has been arguing that FDA labeling should trump state court judges and juries because the agency’s actions are the final word on safety and effectiveness, which is found in the labeling. And if drugmakers have less latitude to make changes, they can use FDA regs as a defense. Preemption, by the way, will be heard by the US Supreme Court next month in a case involving the Rezulin diabetes drug.

Not surprisingly, the lobbying group for trial lawyers, the American Association for Justice, “demanded” the FDA withdraw its proposal, saying it would allow drugmakers “to claim immunity for failing to warn patients of potential drug hazards. The rule directly contradicts congressional intent that the duty to warn people of a drug’s hazards rests with the drug company, who is in the best position to warn about problems associated with the drug.”

“With this rule the FDA thumbs its nose at Congress, and leaves patients in the dark about the safety of the prescriptions they are given,” AAJ president Kathleen Flynn Peterson, says in a statement. “This rule would make it more difficult for consumers injured by prescription drugs to hold drug companies accountable. We encourage Congress to curb this agency’s abuse of power.”

The FDA proposal does, however, indicate the agency continues to believe drugmakers should still be able to make label changes unilaterally, and that involves “newly acquired safety information.” If that stands, then trial lawyers may be able to continue charging drugmakers with being irresponsible, or worse.

Hat tip to Drug and Device Law blog and the WSJ Health blog.