Federal Prosecutor Warns Drug Companies on Off-Label Promotion: "This Must Stop''

Last Updated Jan 27, 2009 3:17 PM EST

Laurie Magid, the acting U.S. attorney for Pennsylvania's Eastern District, has written a strongly worded warning to drug companies that they must stop promoting off-label uses for drugs or face the consequences.

The warning comes after both Pfizer and Eli Lilly paid record fines for off-label promotion of Zyprexa and Bextra, respectively. Lilly paid $1.4 billion and Pfizer paid $2.3 billion.

Magid, writing in the Philiadelphia Inquirer, said:

These cases should send a clear message to the entire pharmaceutical industry: This conduct must stop. Doctors may on a patient-by-patient basis decide that, in a particular case, an off-label prescription is the best option. But drug reps with glossy brochures, catchy slogans, and no medical training should not be misleading doctors into thinking that the FDA has approved an off-label use.

Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer.

Off-label-marketing cases are not easy to bring. They can take years and involve the review of millions of documents by an alphabet soup of federal agencies, state regulators, and law-enforcement officers. But we will keep bringing them until this practice stops.

The remainder of the editorial is an extended dissection of Lilly's wrongdoings on Zyprexa, including:
Lilly deliberately declined to have the drug thoroughly tested and to seek FDA approval for additional uses. Instead, it launched the "Viva Zyprexa" campaign, gave sales representatives glossy brochures about fictitious patients ... and had them use the slogan "Five at five" - that is, 5 milligrams of Zyprexa at 5 p.m. would keep elderly patients quiet all night, not bothering the doctors or nursing staff in a long-term-care facility.
Magid also mentions Cephalon's mismarketing of Actiq:
Actiq, is a potent painkiller intended only for cancer patients who are already tolerant of other painkillers and still suffering pain. Yet, with the slogan "Pain is pain," Cephalon marketed the drug to primary-care physicians for common ailments such as back pain and migraine headaches.
Interestingly, the FDA was recently persuaded to consider relaxing the off-label laws. Magid and the commissioners thus seem to be on a collision course.