FDA backlog keeps lower-priced generic drugs from reaching consumers

September 12, 2016

generic RXMembers of Congress calling for more affordable alternatives to high-priced drugs are demanding that the Food and Drug Administration (FDA) resolve its backlog of generic drug applications that stretches back almost four years.

The FDA had 4,036 generic drug applications awaiting approval as of July 1, Kaiser Health News reports. The median time for final FDA signoff on generic drugs is now 47 months.

The delay is a problem because without cheaper generic medications, consumers are forced to pay high prices for brand-name drugs.

The backlog of generic drugs seeking FDA approval has existed for several years. However headlines exposing the 400 percent price increase for the EpiPen, which delivers life-saving allergy medication, have refocused the spotlight on the FDA. Some patients are forced to pay more than $600 out of pocket for an EpiPen two-pack.

Mylan, the company that owns the EpiPen, told NBC News that middlemen and suppliers have forced them to raise prices. Under pressure, the company announced it will soon offer a $300 generic alternative. Meanwhile, two industry insiders told NBC that the company pays no more than $30 per device.

Have you been hit by skyrocketing drug prices? Share your story at VoicesforAffordableHealth.com/share-your-voice/