For years, pharmaceutical drug manufacturers have argued that the FDA approval of a drug preempts a duty to warn claim. If this argument had succeeded, FDA preemption would bar claims for injuries caused by a manufacturers’ failure to warn about risks associated with their FDA-approved prescription drugs. President Bush’s administration has long supported this view in spite of the fact that his FDA has often been accused of not minding the store with respect to the risks associated with the drugs it approves.
Today, President Bush decided not spend to political capital on this issue, signing the Prescription Drug User Fee Reauthorization Act (PDUFA), H.R. 3580. This new law creates new federal safety requirements for pharmaceutical companies. This bill makes crystal clear that regardless of FDA approval, the duty to warn remains with the pharmaceutical companies to adequately provide a meaningful warning about the risks associated with the use of their product. Of course, the manufacturer’s duty to warn the ultimate consumer of prescription drugs is limited, as it probably generally should be, to advising the prescribing doctor of the drug’s potential dangers in the absence of contrary FDA regulations. The FDA maintains the authority to require label changes but the burden to warn rests with the pharmaceutical company. In other words, pharmaceutical companies can no longer hide behind the FDA’s skirt and argue that FDA approval absolves them of the duty to warn. Drug companies certainly can still argue to the jury that FDA approval is indicia of the fact that no duty existed.
This is the first time Congress has made any comment on the issue of labeling of pharmaceutical drugs. I have moderate political views and I try very hard not to make this blog about politics. But there is no denying that this bill never gets passed if the Democrats do not take control of both houses of Congress.