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Prosecutor: Off-label promos 'must stop'
The feds are warning you: No off-label marketing, or else! Coming on the heels of two big settlements related to alleged off-label promos--Eli Lilly's $1.4 billion on Zyprexa marketing and Pfizer's $2.3 billion on Bextra--this warning appears to have teeth.
According to BNet Pharma (which picked up on an op-ed in the Philadelphia Inquirer), the acting U.S. attorney for Pennsylvania's Eastern District is promising consequences for drugmakers that fail to heed the rules against pushing meds for uses not approved by the FDA.
"These cases should send a clear message to the entire pharmaceutical industry: This conduct must stop," wrote Laurie Magid. "Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer."
Magid lambastes Lilly's "Viva Zyprexa" campaign, and she took Cephalon to task for targeting primary-care docs with the cancer painkiller Actiq. It's not easy to prosecute off-label marketing cases like these, she writes, promising, "But we will keep bringing them until this practice stops."
- read the post at BNet
- check out the Inquirer column
Related Articles:
Did Lilly chief support off-label promos?
Cephalon finalizes $425M off-label settlement
FDA flubs off-label enforcement
Pro/Con on FDA off-label proposal
Should off-label journal promos be OK?
Comments
Zyprexa claims being stonewalled
Where is the (now up to) $4.6 billion Eli Lilly Zyprexa settlement going as many victim claimants haven't been paid yet? It's the largest pharma-fraud-whistleblower case in US history.
There must be millions out there harmed by this drug.
Daniel Haszard
And how many tens of millions are harmed because their doctor is unaware of the potential uses of currently available drugs?
Get a clue. This isn't about "protecting the consumer". It is about cash and career.
Pharma is now seen as the bad man with deep pockets. Every AG with even a wisp of aspiration sees these cases as a slam dunk to a huge payout for their cash strapped state or agency, and a career launching press release. And the generic addicted insurance co, managed care, and state Medicaid love it, as it cuts the usage of brand name drugs, fattening their bottom line.
But it is we, the health care consumers, who are getting screwed. The pharma (must as public cos do as if they are to survive) pass along the cost. Or they slash employees, slowing down the R&D of new drugs.
30,000 known diseases of man, only 10,000 have any treatment? That's because the 20,000 left are so rare, and cost of drug development is skyrocketing under the risk adverse FDA, that no person with a dime and a calculator would ever invest in this areas.
Wake up, America. This is bad policy.
We have a ludicrous double standard today. Enzyte and Lipowhatever are making claims all night long on basic cable to cut your fat and harden your member, without a shred of clinical data or FDA review. And we have quacks sleazing books and of all things, calcium (!) to patients with late stage cancer. And let's not forget tort attorneys talking smack about nearly every drug under the sun and scaring patients who may still need this medicines!
But we can't have trained pharmaceutical professionals introduce medical peer reviewed medical journal articles to trained medical professionals? How did the government become the only arbiture of science.
What ever happened to freedom of speech?
We need to put doctors back in charge of patients. Not Washington and state capital bureaucrats!
The DOJ release, just add www. to the beginning:
usdoj.gov/opa/pr/2009/January/09-civ-038.html
To Daniel Haszard: qui tam relators will receive $78,870,877.00
Zyprexa, is approved for short term treatment of serious psychotic disorders (like bi-polar & schizophrenia), but was being used to treat agitation, aggression, hostility, dementia, Alzheimer’s dementia, depression and generalized sleep disorder. None of these uses for Zyprexa had been peer reviewed or gone through clinical tests or trials to prove efficacy.
They had marketing teams targeted nursing homes and then they started pushing to primary care docs. The company saw a way to increase sales of this drug and took it. As acting U.S. Attorney for the Eastern District of Pennsylvania, Laurie Magid said, "Off-label marketing created unnecessary risks for patients. People have an absolute right to their doctor’s medical expertise, and to know that their health care provider’s judgment has not be clouded by misinformation from a company trying to build its bottom line."
So please, do not listen to the Anonymous poster claiming, freedom of speech issues and that potential uses for medicines are being withheld from doctors, or to me for that matter, read the case and decide for yourself.
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