FDA’s proposed rule change could cost America billions of dollars

Safety First - The Cooper Firm

FDA Generic Drug Change

The FDA has proposed removing the requirement that generic drugs carry warning labels identical to those on their name brand equivalents. The irony is that with the major federal expansion of healthcare, the Health and Human Services agency is trying to save money everywhere possible while the FDA is proposing changes that could increase the cost of generic drugs and medical bills by billions of dollars.

Almost 8 in 10 prescriptions filled in the United States are filled with generics. The number is increasing as more drug manufacturers make generic equivalents. These generic drugs have kept medicine affordable for hundreds of families while keeping national medical cost down.

For almost thirty years, the FDA has used the 1984 Hatch-Waxman Act which ensures that generic drugs be duplicates of the FDA-approved name brands. It also allows for these generics to be freely substituted for the name brand drugs.

The proposed change will confuse consumers and will force the generic drug manufacturers to produce more costly research. There is a strong chance that more lawsuits could emerge that would allege that the labels are inadequate. The FDA has stated that Americans save about $158 billion with generic drugs. With the proposed change the federal government will end up paying. Hopefully the FDA will take into consideration how costly this change will be for the nation and the economy.

Source: The Hill, “FDA Rule Change is a prescription for mega lawsuits,” Lisa A. Rickard 9/20/2013.

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