Labels on generic drugs not required to disclose risks, side effects

Pharma-friendly law puts everyone who takes a generic drug at risk

For years Big Pharma has been hiding a deep, dark secret about generic drugs.

And it’s one that could harm – or even kill – you or someone you care about.

We’ve all been told that generics are cheaper and exactly the same as brand-name meds.

But drug companies are finding new and potentially deadly risks with generics all the time.

They’re not just keeping these side effects from us – under law, they’re not allowed to tell us about them at all.

It’s gotten so crazy that even the FDA is trying to change things.

But Big Pharma is fighting them tooth and nail – and that means we all need to act now to keep ourselves and the people we love safe.

Hiding the truth

If there’s one thing Big Pharma loves, it’s being able to sell all the dangerous drugs they want without any accountability.

And that’s exactly why they’re fighting so hard to protect the law that covers new warnings on generic meds.

You see, if a new risk is discovered about a medication, and if that drug is one of hundreds that are only available as a generic, by federal law mum’s the word.

Seriously! Drug companies literally can’t warn us at all – and you can bet that suits them just fine.

It’s all because of a law that was enacted back in 1984 to streamline approval of these lower-priced drugs. But that legislation has eroded into a giant, Jupiter-sized loophole.

Just ask Karen Bartlett. The New Hampshire woman spent months in a coma, lost most of her vision and over half the skin on her body after taking an anti-inflammatory drug called sulindac.

A jury found the generic drugmaker responsible for not warning her or her doctor about those side effects. But the Supreme Court overturned that decision, and ruled that, under federal law, the drug company didn’t do anything wrong.

Are you kidding me? Where’s Judge Judy when we need her?

And even if a brand-name version of a drug is still being made, that’s no guarantee you’ll be informed about new risks, either.

You see, under this bizarre legislation, a generic drugmaker can’t update a label or even send out a letter to doctors warning of a risk until the company that makes the brand-name drug does so first.

And then, the generic drug companies wait some more while the change gets approved.

At this point even the FDA said things need to be fixed! And you know the problem has gotten bad if they woke up someone at the FDA to deal with it.

Three years ago the agency proposed legislation that would allow generic drugmakers to update labels all on their own. And really, that’s just common sense.

But Big Pharma, along with others who stand to lose – such as pharmacy chains CVS and Rite Aid, insurance companies, and industry trade groups – practically had a cow.

And with their allies in Congress, they’ve managed to keep it at bay.

The new rule was going to be published late last year. Then it was pushed up to this July.

Now, I’m hearing that the House Appropriations Committee is doing a work-around by proposing a bill that would keep the FDA’s hands tied, making this rule effectively dead in the water.

What it all boils down to is that if your pharmacist hands you a generic drug, you stand very little chance of knowing about recently discovered problems or even life-threatening dangers from it.

But despite all the attempts to keep things status quo, there’s still time for us to tell our representatives how we feel about this kind of foot dragging when so many lives may be at stake.

So here’s what to do.

First, check out this list of members of the House Appropriations committee. And if you see your representative there, contact them and let them know that you won’t be voting for anyone who’d rather protect billion-dollar drug companies than folks like us.

Sources:
“Generic drug labels don’t always list known side effects. It’s time to change that” Ed Silverman, April 25, 2016, Stat, statnews.com