If this legislation passes, drugs will become more dangerous than ever
The 21st Century Cures Act is one of those long-winded bills that no one really bothers to read.
In fact, the drug companies and their friends in Congress are counting on it.
They’ve loaded the 393-page bill with all the right buzzwords — like “medical innovation,” “breakthrough therapies,” and “putting patients first.”
But this bill doesn’t put you first. Not by a longshot.
It would jeopardize your safety by approving risky new drugs at light speed. It would even attack your pocketbook by making it harder to get cheaper generic medicines.
But the most frightening part of this bill is a stealthy section nobody is talking about.
The 21st Century Cures Act wants to remove one of the last protections you have against unproven, untested drugs. And if it passes, it will practically hand the keys to the FDA to Pfizer, Eli Lilly, and every other drugmaker out there.
Padding the bill
You can bet Big Pharma execs were high-fiving after the 21st Century Cures Act was introduced in Congress. A lot of the bill sounds like something Pfizer told Santa it wanted for Christmas.
Only the role of Santa here is being played by Representative Fred Upton — the bill’s sponsor and chair of the House Energy and Commerce Committee.
Upton should be awfully familiar with what Big Pharma wants – Pfizer and health care special interest groups are some of his biggest campaign donors.
And Upton didn’t disappoint them with his new bill.
The 21st Century Cures Act would dramatically shorten review times for new and potentially dangerous drugs. Even former FDA Commissioner Margaret Hamburg called that a “terrible mistake.”
The bill also would extend patents on new drugs by years to keep generics out of the market. So while the drug companies make billions in extra profits, you end up paying sky-high prices for your medications.
Explain to me again how this bill puts you first?
But one particularly alarming part of the 21st Century Cures Act would spell the end of whatever “power” the FDA still has to regulate the drug industry.
It’s a sneaky little clause that would allow drugmakers to pitch their products for almost any use or condition — FDA approved or not.
That’s called “off-label” marketing, and it can carry very, very big fines. But if the 21st Century Cures Act becomes law, the sky’s the limit and the penalties are out the door.
Have a diabetes drug you think could treat ingrown toenails? How about a Parkinson’s med that might be good for acne? Big Pharma can run and tell doctors about these new, “suggested” uses – whether they’re scientifically proven or not – and sell billions more pills.
So how do you benefit from Big Pharma selling drugs for conditions they were never meant to treat?
You don’t – and you’re not supposed to.
This is about gutting the few remaining powers the FDA has left. And it’s about helping drug companies pad their bottom lines while making sure they never have to pay massive off-label fines again.
AstraZeneca had to fork over $520 million to the feds for off-label, unapproved marketing of its schizophrenia drug Seroquel. Abbott paid $1.5 billion for illegally promoting its antipsychotic med Depakote, and the motherlode of pharma penalties was paid by Pfizer several years ago. It was fined $2.3 billion for promoting non-approved uses for four of its drugs.
But when the 21st Century Cures Act gets signed off by Obama, that will all be history.
Upton and his E&C committee say there will be an “aggressive schedule” to get the 21st Century Cures Act on Obama’s desk – and there’s currently a companion version speeding through the Senate.
So it’s urgent that you contact your senators and representative and tell them that as this bill stands, it’s nothing more than another gift to Big Pharma.
And that’s something you — and your vote — won’t be standing for.
Source:
“Lawmakers propose allowing pharma companies to share some off-label information” Jaimy Lee, March 24, 2015, Medical Marketing & Media, mmm-online.com
