Off-label use too profitable to stop

INDIANAPOLIS - After Pfizer Inc. was slapped last week with a record $2.3 billion in fines for illegally marketing some drugs, critics cautioned that even that eye-popping total is unlikely to end the sometimes-dangerous practice of promoting drugs for unapproved uses.

The penalty pales compared to the billion dollars or more in annual revenue that a blockbuster drug can generate, and new government guidelines stir worry that the marketing of medicines for uses not approved by the Food and Drug Administration will become easier.

"Drug companies will continue to market off-label unless the financial downside makes it unprofitable," said Adriane Fugh-Berman, a Georgetown University associate medical professor.

Off-label marketing is a tricky issue. Doctors say prescriptions for uses not noted on a drug's package label - the fine-print insert that comes with the prescription - play a crucial role in treating patients, especially those with deadly illnesses and few treatment options.

However, the FDA prohibits companies from promoting their drugs for uses it has not specifically approved.

Huge fines for those caught violating these rules usually just nibble at drug company sales totals.

Pfizer's fine is the largest health-care fraud settlement in U.S. Justice Department history. But that $2.3 billion total stands small compared with the $44.2 billion in pharmaceutical sales the world's largest drugmaker rang up last year.

"$2.3 billion looks like a lot of money," Fugh-Berman said. "But these are highly profitable drugs. It will not take them very long to make up that deficit."

Pfizer by no means corners the market on off-label marketing fines.

Earlier this year, for example, Eli Lilly & Co. agreed to pay $1.42 billion to settle a case over the marketing of its top seller, Zyprexa, an antipsychotic drug.

Court documents say Lilly made "hundreds of millions of dollars" through off-label Zyprexa promotions.