A five-member majority of the U. S. Supreme Court concluded in late June that "it makes little sense" to bar suits against generic drug-makers while allowing them against brand-name manufacturers1.
The majority, however, sided with the supremacy of federal law in its potential conflict with state law, in that federal law bars manufacturers from labeling that varies from the FDA-approved labeling of the branded drugs they imitate. Thomas reasoned in writing the majority opinion that it would be "rare" that harmful side effects could become known by the time generic drugs come on the market.
Such thinking flies in the face of the importance of post-market surveillance and the continued collection and analysis of data upon a drug's usage - even after it is manufactured in generic camps. This is because the initial approvals and labeling for branded drugs are largely based on clinical trials in which research participants are highly screened. The results are recognized not to be widely generalizable to the entire population. This is especially true for those segments typically screened out automatically of early research altogether. The labels we end up are often so broad that that they aren't even useful to doctors, much less patients. We consumers tend to even overlook them and dismiss them as useless. Still worse, what we think is the side effect of a drug could be our body's announcement of a new disease or condition or the advanced stage of an existing one, but based on the latest Supreme Court ruling we might never know this.
Moreover, we are constantly learning new information and insights about various conditions, disease processes (particularly degenerative ones) and even the aging process itself in which risk factors for side effects may change depending on the stage of one's condition. Moreover, we are only beginning to learn about the effects of drug interaction, with the average Medicare beneficiary on five prescription drugs and often more.
The bottom line is that labeling must be as dynamic as healthcare knowledge itself in order to do the job of keeping us safe and protected. The Supreme Court got this one wrong, dead wrong, and it may mean the difference between life and death for countless Americans to come, forced to use a generic drug by their healthcare insurance plan but unsuspecting of how dated the warning labels might be. Or barred access to a helpful, economic drug option because the labeling suggests a contraindication that has been disproved by subsequent, post-market research. Either way, the consumer loses.
Nancy Muller, PhD
1Barnes R. June 23, 2011. Supreme Court protects generic-drug makers from being sued for lack of warning. The Washington Post, downloaded June 24, 2011 from http://www.washingtonpost.com/politics/
Published On: July 15, 2011