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FDA Out of Order

Timely Insights on Laws, Issues and New Developements

FDA glassThe meager change the FDA is offering now regarding generic drug regulation is far too little to late to help people who have suffered and continue to suffer the enormous injustice of five judges on the high court who have left them no remedy for their injuries. The impossibility defense that the generic drug companies offered in Mensing and Bartlett doesn’t begin to pass the smell test, as judges from the minority made very clear in their dissent in both those cases. It boggles the mind that the Supreme five can let generic drug companies enjoy billion-dollar profits with virtually no accountability. That situation does not obtain in any other industry, and it is particularly absurd and unjust when it comes to drugs that the FDA recommends people take; the agency promotes generic drugs on its web site, yet fails to do all it can to hold generic drug companies responsible when the drugs they make injure people.

The FDA should always err on the side of safety and on the side of citizens in every case, but they seldom do. The recent recall of generic Wellbutrin proves just how dysfunctional the agency is. Of course there are people at the agency who do a fine job with the limited resources at hand. But Big Pharma has, for many years, lobbied to weaken and underfund the FDA and has done so successfully, to the detriment of us all; it has hired former FDA officials in a scandalous revolving door operation that compromises the agency’s  integrity at every turn.  The FDA actually supported the Bartlett decision, filing an amicus brief to leave a woman crippled and disfigured by a generic drug, Karen Bartlett, unable to obtain any compensation, helping overturn her $21 million  verdict from a jury in the state of Vermont.

When the American public begins to pay attention, perhaps things will change. There is currently a steady erosion of citizen’s rights, as corporations, with the help of the nation’s highest court, take more and power and leave citizens increasingly defenseless.


  • Generic Drug Injustice for All
  • Supreme Court’s Generic Drug Injustice

by Matthews & Associates

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