Drug companies can now say anything they want about the meds they make

FDA ‘officially’ turns the keys over to Big Pharma

The FDA just declared open season on anyone who takes prescription drugs.

Its official plan now is to do even less to protect us.

And the agency is making no bones about this new scheme. It even published a public notice announcing it.

Once again, we’re on the losing end of what’s becoming a very short stick.

What do you think Big Pharma would do if all the FDA rules and regulations about drug labeling vanished tomorrow?

Why, you’d have the sales crew for each and every drug maker rushing to your doctor’s office to tell him some great news.

“We’ve now learned Dr. Smith, that [drug X] isn’t that dangerous after all! Look, here’s a study we did showing it’s actually as safe as mother’s milk.”

If that sounds crazy to you, it’s almost exactly what the FDA has come out and said it will now allow. Big Pharma can say anything it wants about its products, and the FDA will just look the other way.

The plan is officially called “guidance for industry.” And it reads like a Christmas wish list written by Pfizer or AstraZenica.

This “guidance” says that if a drug maker thinks that FDA-approved drug labeling language makes a drug sound too dangerous, then it can present and discuss with your doctor material that “rebuts” or “refines” that risk.

And all without any interference from the FDA.

If you thought Big Pharma was pulling the strings before, it’s now official!

The rules, as they were previously written, say that drug companies are bound and tied by what the FDA had approved for a drug’s label.

Telling a doctor that any risk isn’t all that bad, or has been disproved, is something that has cost Big Pharma billions in fines up to now.

It’s been just as big a No-No as having a sales rep pitch a drug for an off-label use.

In fact, to get your drug label officially changed was a really big deal. One that required a company to “prove” its case to the FDA.

But now that’s not even necessary! Why bother to change a label when you can go right to the source — the guy who is signing your prescription — and tell him whatever you want directly?

All that has to be done is to find a study — or have “your people” do one — that says what you want it to say. Then, salesmen can zip off copies and run to tell doctors the news.

And here’s the extra sneaky way the FDA put this plan in motion.

Instead of proposing a new law that would need congressional approval — or even a regulation — it issued a “guidance.”

Now a “guidance” isn’t a formal, or even legally binding rule. It’s a way for the FDA to announce its intentions. A sort of wink-and-nod notice to go right ahead, we won’t “object.”

Dr. Sidney Wolfe, with Public Citizen’s Health Research Group in Washington, just wrote to HHS Secretary Sylvia Burwell asking that the FDA be ordered to withdraw this “dangerous” new plan.

Of all of the dirty tricks I’ve seen the FDA pull over the years, this has to be one of the most reckless and dangerous maneuvers it has ever come up with.

While the time period to make comments at the FDA has closed, I will be closely watching this and keep you posted as to what’s going on.

In the meantime, make sure you ask your doctor what he knows about any drug he is recommending (especially for off-label use), how often has he prescribed it for your condition and for how long? Plus, has he heard any issues from other patients?

Because if the FDA is going to hand the keys over to Big Pharma, at least you can work with your doctor to put on the brakes.

Sources:
“Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products A Misguided Approach” Sidney Wolfe, MD, Journal of the American Medical Association, JAMA Internal Medicine, archinte.jamanetwork.com