Waiting for FDA approval


(KUTV) 52-year-old Mark Wilson’s body was being destroyed by a sarcoma. His doctors wanted him to try a drug they thought would better target the disease. The drug has been through trials and is FDA approved - but his insurance company refused to pay for it because it had not yet been approved for sarcomas – only liver and breast cancers.

It was a similar story for little Brecklyn who was born with diabetes. Her doctors wanted to put her on a glucose monitor but, again, insurance balked. The monitor is FDA approved, but not FDA approved for children under two years old.

Erin Fox is the senior director of drug information for the University of Utah. She says it's not uncommon for a patient to remain in pain or even die while waiting for a drug to get FDA approval.

"It's really frustrating to see that long approval time," she said. "It's so hard to feel like you have a good option, then to have a third party, like an insurance company, kind of squashing the entire plan."

Still, Fox says it's important to remember that insurance companies have limited resources and that many drugs that seem promising don't end up performing all that well once they get approval and come to market.

“Not every drug only has good effects," she said. "After drugs get approved on the markets, that's when we learn the most about the side effects."

According to federal law, the FDA has a goal to approve drugs in between six and 10 months when the drug seems effective and safe.

The FDA has more information about what goes into getting a drug or medical devise to market on it’s website.

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