Drug Company Warns Doctors Against "Off Label" Use of Natrecor at Clinics
Johnson & Johnson is apparently acting on some two-month old advice from an expert panel of cardiologists in attempting to restrict the prescribing of its heart-failure medicine Natrecor to FDA-approved indications, only. Some cynics, however, see this action by Johnson & Johnson as having more to do with a subpoena for documents related to the sales and marketing of Natrecor which the drug company received a few weeks ago from the U.S. attorney's office in Boston. Either way, the current issue for Natrecor appears to be the "off label" prescribing and use of Natrecor.
One step taken by Johnson & Johnson (J&J) is that, during the week of August 1, 2005, it added a disclaimer to a Natrecor hotline used by doctors looking for information on how to charge Medicare and insurance companies for Natrecor infusions. According to Matthew Herper, on Forbes.com, "the recorded disclaimer warns that there is a 'lack of clinical data' on using the drug outside the hospital, and that Scios, the J&J unit that sells Natrecor, 'does not recommend Natrecor for this use.' Mr. Herper reports that the J&J recording goes on to say "As a result, the support line does not maintain or provide information regarding the physician office or hospital infusion clinic use of Natrecor."
Mark Wolfe, a J&J spokesman, has said that the recorded message on the Natrecor hotline is part of a more comprehensive plan to implement the recommendations of the expert panel of cardiologists, and that J&J will be taking additional measures regarding Natrecor in the weeks to come.
In June 2004, Harvard's Eugene Braunwald chaired the panel of cardiologists convened by J&J to study the emerging drug-safety issues surrounding Natrecor, with an emphasis on the increasing level of "off label" use. The Braunwald panel recommended that Natrecor should be used only as approved by the FDA, which is in patients who show up at the hospital with acutely decompensated congestive heart failure. The expert panel stressed that Natrecor should not continued to be used "off label" -- namely, patients getting regular appointments to receive the drug in an out-patient setting. "Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used," the panel wrote.
It appears that J&J is listening to Dr. Braunwald and his colleagues.
(Posted by: Tom Lamb)