Guidance to Doctors Prompted by Natrecor Expert Panel or US DOJ Investigation of Sales Tactics?

Johnson & Johnson’s Scios unit announced on August 22, 2005 the launch of a new program intended to educate prescribing doctors regarding which patients should receive Natrecor and, conversely, those patients for whom Scios does not recommend the use of Natrecor based on currently available clinical data.

Natrecor, an intravenous treatment, was approved by the FDA in 2001 for use in acutely ill heart-failure patients, people who arrived at the hospital with severe shortness of breath.  In the years following this FDA approval, however, Natrecor was increasingly used in outpatient infusion clinics, where heart-failure patients came for regularly scheduled treatments. Such "off-label" use contributed to sales of Natrecor in 2004 of $400 million.

The current controversy over Natrecor’s off-label use in an outpatient setting arose after the publication of studies in two medical journals questioned whether Natrecor contributed to worsened kidney function and increased death rates.

There are conflicting theories as to why Scios and Johnson & Johnson (J&J) may have launched their new initiative at this juncture.  According the drug companies, this Natrecor recommended use initiative is a response to recommendations which the companies received recently from an expert panel made up of leading cardiologists. On the other hand, this decision by Scios and J&J to conduct an education campaign follows close on the heels of a disclosure last month that the U.S. Department of Justice (DOJ) was investigating whether Scios had engaged in the unlawful promotion of outpatient off-label use of Natrecor.

While it is not illegal for doctors to use drugs in ways beyond the FDA-approved indication — such as the regularly scheduled infusions of Natrecor in outpatient clinics — drug companies are prohibited from promoting their respective drugs for such unapproved uses. Scios and J&J have denied that they promoted any unapproved, or off-label, uses of Natrecor.

In a statement about this new Natrecor initiative, Scios said its education campaign would include training the entire Natrecor sales force on the recommended uses of the drug, as well as providing new promotional materials directed at those doctors prescribing Natrecor and putting educational advertisements for Natrecor in leading medical journals.  Dr. Darlene Horton, senior vice president of clinical research and medical affairs at Scios, provided this additional comment:

We are committed to our recommended use initiative and we are confident that it will further assist healthcare professionals in identifying appropriate patients for treatment with Natrecor….  Natrecor continues to be an important therapy for patients presenting to the hospital with ADHF. These patients have few well-studied treatment options.

Finally, Scios said that it has sent a letter to more than 160,000 healthcare professionals advising doctors and others on the proper prescribing and use of Natrecor.

(Posted by: Tom Lamb)