There's a chance your doctor will prescribe a drug approved for a related or even different disease.
Doctors prescribe off-label drugs frequently. It's legal.
They make the call based on knowledge of the drug's prospective capabilities, the disease itself and on information colleagues may have shared in journals, conversation or online.
But woe betide a company that promotes a drug for an as-yet unapproved purpose. The Food and Drug Administration and Department of Justice won't like it.
It's one thing for a doctor to make a judgment call and suggest off-label use to a patient. It's quite another for a drug firm to suggest, imply, hint or wink-wink-nudge-nudge the doctor to do it.
"The industry gets into big trouble for anything the FDA perceives as promotion of off-label use," said Joel Hay, professor of pharmaceutical economics at the University of Southern California.
A Fine Mess For Pfizer
How big is that trouble? Just ask Pfizer (NYSE:PFE - News).
Last month, the company concluded a settlement with the Justice Department in which it pleaded guilty to criminal charges resulting from off-label promotion of its now-withdrawn Bextra pain drug.
The fine was a record $2.3 billion to settle both criminal and civil charges relating to Bextra and 13 other products. It was levied after Pfizer was deemed a repeat offender in marketing drugs to patients and doctors for unapproved conditions.
Pfizer withdrew Bextra, a painkiller, in 2005. Pfizer's marketing team promoted the drug for acute pain, surgical pain and other unapproved uses. Meanwhile, sales reps promoted the drug directly to physicians for those unapproved uses and dosages, according to the Justice Department.
In the settlement, Pfizer agreed to a corporate integrity program monitored by the Department of Health and Human Services.
It wasn't Pfizer's first offense. In 2004, the company pleaded guilty to criminal charges of illegally marketing epilepsy drug Neurontin for migraine headaches, pain and bipolar disorder. Pfizer paid $430 million to federal and state governments.
Paying $2.3 billion on the latest charges hurts but doesn't cripple Pfizer. With its recent acquisition of Wyeth, the firm's market cap is $118 billion and its annual revenue is $46 billion.
Until the latest Pfizer settlement, the biggest penalty had been the $1.4 billion Eli Lilly (NYSE:LLY - News) paid in January for off-label promotion of its Zyprexa schizophrenia drug.
Again, a serious amount, but not devastating to Lilly, which boasts a market cap of $39 billion and sales of $21 billion.
Still, it's enough to cause one biopharma to take preemptive action.
On Oct. 1, Allergan (NYSE:AGN - News) filed a lawsuit against the FDA contending that the agency's ban on off-label marketing violates the firm's First Amendment free speech rights.
Allergan wants to be able to tell doctors what Botox can and can't do for conditions beyond those for which the FDA approved it.
Citing a 2006 study reported in the Archives of Internal Medicine, Allergan said in its statement that "it is estimated that approximately 20% of all prescriptions in the United States are used by physicians for off-label indications and are often used to treat very serious conditions such as cancer and AIDS."
Allergan, with a market cap of $17.5 billion, is responding to the FDA's crackdown on off-label marketing, says Gary Nachman, analyst with Leerink Swann.
The company says its lawsuit is aimed at removing limits on promoting Botox for as-yet unapproved uses, and has no link to a federal investigation started in 2008 into Allergan's previous off-label Botox marketing.
In a press release, Allergan says it wants to give important information to doctors who might use Botox off-label.
The company wants the legal right to "proactively provide comprehensive information to physicians about ... off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique."
Botox is a key Allergan product, with 2008 sales of $1.3 billion. It's best-known for its approved use to smooth out facial wrinkles.
Wrinkle-smoothing is not a medical necessity. Customers are stretching out the intervals between treatments, and sales are down by more than 3%.
Botox is also approved for severe neck spasm and pain, eyelid twitching, misaligned eyes and excessive perspiration.
Strong Warnings Mandated
The FDA said in April that Botox and competing products must carry strong warnings that the toxin can spread in the body. The FDA acted on reports that deaths had occurred from botulinum toxin injected for unapproved uses.
In 2008, half of Allergan's Botox sales were for cosmetic use and half for therapeutic. This year, therapeutic use will account for 55% of Botox sales, Nachman says.
Other possible, but not approved, uses for Botox include post-stroke spasticity, migraine and over-active bladder. The drug also might help children with juvenile cerebral palsy, analyst Nachman says, but too great a dose could cause respiratory failure.
An FDA clampdown on off-label marketing won't stop off-label use. Nor should it, says Les Funtleyder, analyst with Miller Tabak and author of the book, "Healthcare Investing: Profiting from the New World of Pharma, Biotech, and Health Care Services."
Off-label prescribing can serve a useful purpose. It can give drugmakers insights into possibilities for new therapeutic uses for which it was not tested. And it doesn't cost drugmakers anything.
"The less they spend, the better they feel," Funtleyder said.
Balancing Act
The trick comes in balancing two objectives, he says. One is to learn more about drugs to improve patient health. The other is not to endanger patients.
Allergan bolsters its argument for responsible off-label information by pointing out that both government and private-sector insurers reimburse for many off-label drug uses, including off-label uses of Botox for certain types of adult and juvenile spasticity.
There's nothing to prohibit a doctor from prescribing any legal medication for a patient. Chemotherapy drugs are used almost totally off-label, USC's Hay says.
Amgen's (NasdaqGS:AMGN - News) cancer drug Avastin was used in low doses off-label to treat wet age-related macular degeneration until Amgen developed Lucentis, its own low-dose Avastin, for that purpose.
There's also nothing illegal in a drug firm's doing or sponsoring research into off-label uses, and nothing illegal about publishing the results, Hay says.
Nor is there anything illegal in doctors communicating their findings to each other in any way. They do that in person, in journals and through online social networking.
However, such information will be anecdotal, not scientific.
"It's unlikely to conclusively demonstrate the value of any therapy," Hay said.
Monday, October 26, 2009
Pharma Seeks Cure For Off-Label Woes - Yahoo! Finance
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