Fremont biotechnology firm Scios Inc. is taking the first of a series of steps to curb prescribing of its heart drug Natrecor for uses not approved by the Food and Drug Administration.
The company, a unit of Johnson & Johnson, had been accused of promoting those unapproved uses by a prominent Cleveland heart disease expert. Its Natrecor marketing records were subpoenaed in July by federal prosecutors in Boston. Scios denies promoting the off-label use.
Natrecor was approved by the FDA in 2001 for a type of acute congestive heart failure accompanied by shortness of breath. In the July 14 edition of the New England Journal of Medicine, Dr. Eric Topol of the Cleveland Clinic charged that Scios was aggressively marketing Natrecor for repeated administration in outpatient settings for a “tune-up.” Topol said Scios was showing doctors how to bill Medicare for the off-label treatments. He said the regimen used nearly 10 times the amount of the drug administered to acute-care patients in hospitals and resulted in fees of as much as $700 per dose to the doctors.
Physicians can legally prescribe off-label, but FDA regulations forbid drug companies from promoting such uses.
A Scios telephone hot line for doctors now leads off with a recorded disclaimer advising that due to a “lack of clinical trial data,” Natrecor is not recommended as a scheduled series of infusions in outpatient clinics or doctors’ offices.
Company spokesman Mark Wolfe said the recorded message is just the first of a series of measures Scios will take at the recommendation of a panel of experts it had commissioned in April to evaluate safety concerns about Natrecor. The drug has been linked to kidney malfunctions, and some clinical trials have shown a higher death rate among patients receiving it compared with those given a placebo.
The expert panel on June 13 recommended that Natrecor be used only when patients come to the hospital suffering from acutely decompensated congestive heart failure and labored breathing when at rest. Doctors should consider whether other remedies could give the same relief from shortness of breath, the panel said, and should not administer Natrecor repeatedly in outpatient settings. The panel urged Scios to convey those guidelines to doctors through an educational campaign, and to conduct further clinical trials on the impact of Natrecor on kidney function and death rates.
Topol said Natrecor should be off the market because the FDA lacked sufficient data on its safety and efficacy when it granted approval.
Wolfe said the FDA’s decision was well supported. “More information is available on Natrecor from gold-standard clinical trials than there is for any other therapy available for acutely decompensated congestive heart failure,” he said.