That could make it easier for doctors to get data about so-called off-label uses for a drug.
In the marketing of Xyrem, Orphan Medical pushed off-label uses for which there was no scientific support.
FORBES: Off-Label Pharma Prosecutions Won't Be Silenced By First Amendment Decision
It says there is no evidence supporting the drug in off-label uses, such as in sicker or healthier patients.
It will be interesting to see if online clinical-trial registries provide another way of getting data about off-label uses to doctors.
Making that statement may be important to Medicare because the agency does traditionally pay for some off-label uses of cancer drugs.
But the NCD also contained a specific provision that prevented reimbursement for off-label uses unless patients were enrolled in clinical trials.
FORBES: Two Medical Societies Break New Ground To Test Medical Device
Once a drug is on the market, physicians are free to prescribe it for other conditions, though drug companies can't promote such off-label uses.
Often, Medicare does pay for so-called off-label uses, but as cancer drugs get more expensive it may want to find ways to tighten what gets reimbursed.
FORBES: Dendreon Data Are Merely Moderate, But Stock Surges Anyway
The combination of little benefit and potential risk underscores the need "to set a pretty high bar" for the off-label uses of medicines, Dr. Yank said.
Ralph Brindis, a former president of the ACC, explained that as physicians became familiar with TAVR they grew interested in exploring off-label uses of the device.
FORBES: Two Medical Societies Break New Ground To Test Medical Device
Schizophrenia drugs are also being prescribed for off-label uses.
But in a note to investors this morning, Winton Gibbons, a health care analyst at William Blair, said he believes the probe probably relates to doctors using Rituxan for so-called off-label uses.
For 20 years, federal health and justice officials have concocted and applied a warped set of legal principles which essentially prohibit medical product makers from sharing truthful information (even peer-reviewed journal articles) with doctors about off-label uses.
FORBES: The Dangers Of Information Restrictions On Drugs' Off-Label Uses
Jean Slutsky, director of the agency's Center for Outcomes and Effectiveness, said the research was undertaken because clinicians have indicated that uncertainly over the risks and benefits of NovoSeven for the off-label uses posed a dilemma on whether or how to use the drug.
Gregg W. Stone, a professor of medicine at Columbia University and the author of an analysis of Boston Scientific's stent published in the New England Journal, says that is worried that doctors have pulled back too much from using drug coated stents, in even off-label uses.
The First Circuit Court of Appeals, in a decision yesterday, ruled that a lower court erred when it refused to allow Aetna to sue Pfizer over what it called a racketeering conspiracy to induce physicians to prescribe Neurontin for off-label uses like treating bipolar disorder.
FORBES: Pfizer Loses As Appeals Court Allows Off-Label Marketing Case To Proceed
In 2008, the latest year studied, researchers found such "off-label" uses accounted for 97% of orders for the drug.
The prohibition on off-label drug communications has likely caused unnecessary pain to patients, especially those suffering from cancer and HIV who could benefit from off-label drug and therapy uses.
FORBES: Governor Rick Perry Puts "Off-label" Medical Therapy on Stage
And the review gives Medicare plenty of ammunition not to pay for off-label, or unapproved, uses of Provenge.
应用推荐