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.
