‘You Can’t Snub Your Nose At The FDA’
4 CommentsBy Ed Silverman // May 9th, 2007 // 3:17 pm
That’s what U.S. District Court Judge Patti Saris said earlier this year when she sentenced Schering-Plough and one of its subsidiaries to pay $435 million to settle charges of off-label marketing of two cancers meds. Of course, there are some who would say she’s got it wrong, given the growing list of successful prosecutions.
As the Associated Press reports, Saris was apparently reacting to the spectacle of seeing yet another drugmaker in her court, waiting to be slapped with a multi-million-dollar fine for marketing its drugs for uses that had not been approved by the FDA. Saris “had seen cases like this before, and she was fed up,” the AP writes.
The story, which of course is really for broad consumption, goes on to describe in general terms the increasing prevalence of off-label activity in the industry. The yardsticks - a recounting of the companies that have gotten tagged for the illegal practice. These include Pfizer, Lilly, Serono, TAP, AstraZeneca and, just this week, Medicis and Purdue Pharma.
Since 1997, when the Justice Department began receiving funding earmarked for fighting health care fraud, the AP notes the federal government has collected $11.87 billion in fines for various violations and returned the money to Medicare, Medicaid and other health care programs. The effort has largely been led by the US Attorney’s office in Boston.
Whether law enforcement is having much effect is unclear. One could argue the recent spate of cases actually reflects older activity, and that companies have moved to take corrective steps by improving compliance procedures, implementing new policies and, in some cases, hiring an exec with a compliance background.
On the other hand, the recent episodes in which anonymous AstraZeneca and Pfizer employees have leaked material to various blogs, including this one, also suggests that off-label practices are alive and well, and industry compliance is either ineffective, incomplete or a sad example of ’saying one thing, but doing another.’
Critics argue that off-label marketing continues because the fines and legal bills are seen as a cost of doing business. In 2004, Pfizer paid $430 million in fines to settle allegations Warner-Lambert, which it acquired four years earlier, marketed the epilepsy drug Neurontin for pain and psychiatric illnesses. The drug generated sales of $2.7 billion seller in 2003.
David Franklin, a medical liaison who became a whistleblower against the company, said that even after the settlement , doctors told him that other pharmaceutical companies were still actively promoting their drugs for off-label uses. “The $430 million penalty was widely referred to as a slap on the wrist,” says Franklin, who received $26 million.
“A lot of drug companies are unhappy about this because it reduces sales,” says Jerry Avorn, author of the book “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs” and a professor at Harvard Medical School. “Some of them are unhappy because they really feel they ought to be able to say what they want and let the doctor beware.”
You can read the full story here.[tags]Off-Label Marketing[/tags]
an alternative view
Interesting story; here is another take.
Maybe the industry isn’t involved in massive illegal marketing. Maybe, just maybe, the laws are so unclear (intentially so by both the FDA and DoJ) that it is almost impossible for a company to be compliant.
For instance, if a drug company hands out information published in a peer reviewed journal (JAMA, for instance) that is inconsistant with the label, both DoJ and FDA would call that “illegal promotion” because it MIGHT result in a script being written for an indication not approved by the FDA.
Interestingly, the courts don’t believe this (FDA vs. Henney, FDA vs. Friedman). It would be interesting to see the Washington Legal Foundation’s views published in this article.
This really isn’t cut and dry, and I for one don’t believe the every company in the industry is involved in massive fraud via illegal promotion. If every company is facing the same issue, perhaps it is time for the regulatory bodies to clarify the law instead of forcing settlements from companies.
It bears noting that the government’s False Claims Act/ misbranding theory has NEVER been tested in court — by using the debarment statute (and the now rejected Thompson Memo) they force companies to settle. No one wants to take these to court because of the risk of debartment, and the government continues to be able to shake down companies for millions (which ultimately get passed on to the consumer; where do you think this money comes from?)
an alternative view
whoops; the correct legal cites is WLF vs. Henney and WLF vs. Friedman.
Also, according to AUSA Michael Loucks, there are over 500 ongoing illegal promotion/misbranding investigations going on.
ed
Dear Alt,
First, thanks for writing.
Second, you sound just a wee bit like an attorney. which is fine - Its nice to have an informed point of view show up.
Third, you make a lot of good points. There are disagreements all the time, as I understand it, about what constitutes off-label marketing. And I would imagine some of that is good lawyering, and some is genuine.
I have a hunch the Washington Legal Foundation woulld have quite a lot to say about handing out articles (I covered the free speech issue several years ago, in fact, for The Star-Ledger and found it to be quite interesting, especially since I enjoy free speech myself).
I don’t mean to suggest that every company is out of compliance all the time, jousting over legal definitions aside. I was trying to point out that the issue, such as it is, continues to be a problem to be rooted out. In a word, vigilance is needed. And of course, disagreement over terminology or legal definitions shouldn’t automatically be used as cover for marketing a drug for an unapproved use.
I agree with you, however, that clarifying appropriate laws, to the extent such a move is needed, is a good thing. I won’t pretend to know, off the top of my head, specifics you might suggest. But I’m always happy to go to school. So if there are links you can send along, please do.
Cheers
ed
Drug Law Blog
Off-Label Versus Unapproved: Parsing the Distinction
The Pharmalot blog has a post up today on the prosecution of pharma companies for encouraging off-label prescribing practices. The key bit: Since 1997, when the Justice Department began receiving funding earmarked for fighting health care fraud, the AP…