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FDA backlog keeps generics from coming to market

Written by Diane Archer

In October 2015, there were as many as 3,000 generic drugs waiting to be approved by the Food and Drug Administration. FDA underfunding may explain it in part. So might incomplete information on applications by their manufacturers as the FDA claims. But, whatever the reason, the result is that we end up paying high drug prices, (though some generic drug prices are sky high.)

Generics can cost as little as 20 percent of what brand-name drugs cost; they can also cost a lot more.  Around 8 out of 10 prescriptions are for generic drugs but they account for less than 30 percent of our drug spending.

The 2012 Generic Drug User Fee Amendments now require drug makers to help offset the cost of FDA review. In exchange, the FDA is supposed to speed up approval of these applications.  And, the FDA says it has. However, it also says that the application process is often slowed down because of faulty applications, which may fail to address negative side effects of inactive ingredients or other important information.

Here are four things you may not know about generic drugs and, if you’re interested, a short primer on how federal policy promotes high drug prices.


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