'Off-Label' Drugs: J&J Is Pushing the Envelope

Natrecor, developed by Johnson & Johnson's Scios unit, was approved in 2001 by the Food & Drug Administration for the short-term treatment of heart-failure patients who are having serious problems breathing. Dr Larry M. Altschul was one of the first to use Natrecor longer-term to treat patients with heart failure - an experimental therapy known as an "off-label" use of the drug because the FDA did not specifically approve it for such treatment. Scios has paid to send nurse practitioner Regina Massaro send to meetings with doctors and nurses around the country six times in the past two years to talk about heart-failure management. Massaro can't bring up the subject of chronic Natrecor therapy herself. But Massaro says she frequently gets questions on that topic - and under the rules she is then free to discuss her experiences. While no evidence has surfaced that Scios has broken the rules when it comes to marketing, the company has made moves, including the meetings by Massaro, that prompt discussion of the drug's off-label uses.