Warnings on generics: Supreme Court rules against consumers
I am outraged!
And more than a little scared.
This week, on Thursday, June 23, 2011, the US Supreme Court ruled 5-4 against two women who claimed that they were not properly warned about the risk of taking a generic equivalent drug, saying that consumers were not allowed to sue for side effects not listed on the label. The justices said the generics companies didn’t have the same responsibility as brand name pharmaceuticals to update their warning labels when new side effects were discovered.
Are you kidding me?
Those generic drugs, the ones pushed hard by insurance companies because they cost less, the only ones that some people can afford to take, are not even required to toe the same line for warning labels as Big Pharma? Ridiculous. Absurd. And dangerous.
The two women, Gladys Mensing of Minnesota and Julie Demahy of Louisiana took a generic equivalent of Reglan (originally developed by Wyeth) to treat acid reflux for about four years and developed serious neurological symptoms (involuntary muscle movements). Although the Supreme Court did not dispute that the symptoms were side effects of the generic drug, it said that companies who manufacture generics should not be held to the same standards as research pharmaceutical firms to add new warnings to their labels. Their contention is that the original warning label is sufficient for a generic equivalent.
Justice Clarence Thomas wrote that the reason generics were granted special exemption was that “It is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing drugs more quickly and cheaply to the public.”
But what about our safety and our right to full disclosure? Is the tradeoff for cheaper prescription prices an incomplete warning label about a potentially long-term, debilitating neurological condition? In this case, apparently so.
What does this mean for generic manufacturers? That they may skip merrily down the road producing medications that may or may not negatively impact the end user without telling us about newly-discovered problems.
What does this mean for ADD medications? It means “caveat emptor” – let the buyer beware. The drugs that are “off patent” may or may not have new, serious side effects. But if we take a generic we’ll never know, because there is no requirement that we be told about them. And now, no way to seek legal recourse against the company that produced the drug.
I am reminded of the severe warnings issued to cash-strapped consumers who ordered prescription drugs over the internet from foreign countries. There was no published warning of the purity or efficacy of the mail order drugs. Isn’t that exactly what is going on here? Granted, it is not a contamination or substitution problem, but we are buying (and taking) life-saving drugs without updated information about their potential for damage. So how can we know whether the generic we are taking is prone to cause problems that appeared after the original FDA approval? We can’t, thanks to the Supreme Court.
If Reglan was still under patent, Wyeth Pharmaceuticals (now part of Pfizer) would certainly be held responsible for warning the public about these serious side effects. But not the generic companies. This ruling allows generic drug manufacturers to hide the bad news from us. Until we experience them first hand.
Now I am even MORE outraged.
I will continue to request brand name prescriptions from my doctors. Thank goodness my health insurance still pays for them. My fingers are crossed that yours does, too. Which doesn’t mean those side effects on the label make me feel safer. But at least I know the possibilities.
Tell me about your prescriptions — do you take generics or not? Are you outraged too?