Close the generic drug safety loophole now

My husband and I had our lives forever changed when we lost our only child, Kira Nicole Gilbert, to a generic form of the drug Darvon. Kira was only 22 years old and had her whole life ahead of her. When she entered a room everyone noticed. Her smile was so big and bright and she had a laugh that was simply contagious. 

Six years later, our fight for increased safety and struggle for accountability continues. On Friday, I’ll be traveling from Ohio to speak at an FDA public meeting – to call on them to finalize a rule that would enable generic drug companies to promptly update their safety labeling in response to new research, and to be held accountable if they don’t. 

{mosads}To understand why consumers need this rule now, consider Kira’s story. 

Kira graduated from college with a triple major and was working at an orphanage; she planned to go to nursing school and work in a children’s hospital. She wanted to have a small wedding with lots of yellow flowers. She wanted to give birth to one boy and one girl and adopt third child. She never missed a family gathering. 

Kira tore her ACL on the job and was prescribed Darvon to relieve her pain in advance of her surgery. It didn’t cross any of our minds that this drug could cause her harm. 

Days later, on April 9, Kira did not show up to work, which had never happened before. When her supervisor called me, I went straight to her apartment to check on her. When I arrived I found her on her couch, already turning blue. I will never get that image out of my head. 

Kira died that day from acute cardiac failure. She had no previous history of heart conditions. 

We miss her so much. We hate holidays without her. Everything is a reminder that she will never walk through our front door again. 

What we didn’t know was that there had been growing evidence of the danger of this drug, and the FDA would later completely ban it. But there was no such warning of that danger on the drug’s label. 

We thought we could hold someone accountable for the loss of our beautiful daughter. But this is where it gets absurd. If Kira had taken the brand-name drug, we could have taken our case to court. Yet because she took a generic form of the same exact medicine, we can’t. 

Name-brand drug companies are responsible for updating their safety warnings promptly when they learn of new evidence of side effects. This happens all the time, and it ensures that the manufacturers are monitoring reports of side effects. 

But with generic drugs, it’s different. The Supreme Court said in 2011 that generic manufacturers aren’t responsible for updating the safety warnings on their products and can’t be held accountable in court for failing to warn consumers about dangerous side-effects – even if the manufacturer knew the drugs were dangerous and patients could die. 

The current policy has created a generic drug safety loophole, where generic drug manufacturers don’t have an incentive to monitor side effect reports on their products, leaving millions at risk. 

We all have to be accountable for our jobs. Why should it be any different for drug companies that are making medications that we give to our loved ones? We trust that the medications are labeled correctly and are safe, but if there is no accountability, you can throw that safety out the window. 

The solution is in sight: in 2013, the FDA proposed a rule that would enable generic drug-makers to independently update their safety labeling, and for people like my husband and me to hold them accountable if their labels don’t warn of safety risks. 

The rule has already been delayed once, and now the generic drug industry is fighting against it, to keep no responsibility for their safety labeling. 

On Friday I’m going to tell Kira’s story to FDA officials. They should finalize this rule without watering it down and without any further delay. 

Kira was our world. We lost her because she took a generic drug we had no idea could do her harm. We can’t bring her back. But we can close the generic drug safety loophole so our story is not repeated.

Tammy and John Gilbert live in Cincinnati. Ohio.


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