Waiting on Washington for a generic drug accountability fix
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I gave birth to my son Lucian five years ago. He was born with a heart defect; his lower left ventricle was underdeveloped, and he was not pumping enough blood through his body. A week after he was born, he died in my arms.

Since then I’ve been looking for answers. And what I’ve discovered is that Lucian’s death might have been avoided had I not been taking a certain medication during pregnancy.

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What happened to my family has happened to others. What I’ve learned is that regulators and elected officials in Washington, D.C., are letting generic drugmakers – like the company that made the pills I took – evade accountability when they harm people. This can and must be fixed.

Years ago, my doctor prescribed me fluoxetine to ward off panic attacks. I continued to take the medication when I was pregnant with Lucian. My doctor said it was fine; the warnings about pregnancy on the drug’s labels at the time were minimal.

Now I know a very different story: studies have linked the drug with an increased risk of heart abnormalities in the babies of women who were taking it.

When Lucian was born, the doctors knew right away that something was wrong. He was transferred to a bigger hospital where a team of doctors opened a hole in his chest and inserted tubes and devices to keep his blood flowing.

It was horrific, and a doctor soon told me Lucian was not going to make it. He lived only seven days.

I began searching for answers. I learned how I wasn’t the only one who had a baby born with heart defects after taking fluoxetine. And despite the studies, the warnings on the medication remained minimal, so doctors continued to prescribe it to pregnant women.

I wanted to take the drugmaker to court and hold them accountable. But it turned out I couldn’t have my day in court, because I had taken a generic version of the drug.

Doctors prescribe generics all the time. These drugs often work just as well as the name-brand versions and are cheaper. Some insurers require doctors to prescribe generics for their patients, and in many states pharmacists are required to dispense generic versions of a drug, unless a doctor has specified otherwise.

But according to the U.S. Supreme Court, they aren’t the same at all. Months after Lucian died, the Supreme Court ruled that generic manufacturers can’t be held accountable for inadequate warnings, because they don’t have the same ability to promptly change their labels as name-brand manufacturers do.

If I had taken the brand-name version of this medication, I could have taken that manufacturer to court and tried to hold them accountable. I’d still have to prove my case, but at least I’d have a shot. But because I took a generic version of the drug, I didn’t even have a chance.

In other words, no one could be held accountable for Lucian’s death.

It doesn’t have to be this way, and the Food and Drug Administration seems to recognize this. In 2013, the agency proposed a regulation that would give the generic drugmakers responsibility for updating their safety labels, and make them accountable for inadequate warnings. Last year, I testified at the FDA, urging them to finalize this plan.

Now, the train seems to have come off the tracks. The FDA has repeatedly delayed the plan and last month, the Obama administration said that the regulation might not even be finished until next year. That would put the decision in the hands of the next president.

This fix shouldn’t wait any longer. We put our trust in the companies who make medicines. And when those companies downplay the risks of their products, they are endangering the public, whether they are a brand-name manufacturer or a generics company.

Nothing can be done to bring my Lucian back. But something can be done to make sure that generic drugmakers can change their safety labels – and be held accountable if they fail to warn consumers of risks. I urge President Obama and the FDA to quickly finalize this plan.


Emily Mitchell lives in Chattanooga, Tennessee.