Drug Firms Flout FDA

As reported in the Hartford Courant

U.S. District Judge Patti Saris had seen cases such as this before, and she was fed up.

Another pharmaceutical company was in her court, waiting to be slapped with a multimillion-dollar fine for marketing its drugs for uses that the federal Food & Drug Administration had not approved.

You can't thumb your nose at the FDA," Saris said. She sentenced Schering Sales Corp. and its parent company, Schering-Plough Corp., earlier this year to pay $435 million to settle allegations that it lied to the government about drug prices and illegally promoted the drugs Temodar and Intron A for the treatment of cancers for which they were not approved.

Doctors are free to prescribe drugs for uses that have not been approved by the FDA, but pharmaceutical companies are prohibited by law from marketing drugs for so-called "off-label" uses.

Some industry representatives say the law that prohibits illegal marketing and the affiliated FDA regulations are open to different interpretations and are selectively enforced.

During the past decade, federal prosecutors across the country have aggressively targeted drug companies, including Pfizer Inc., AstraZeneca Pharmaceuticals, and Eli Lilly & Co., for illegal marketing activities.

Just this week, Purdue Pharma, of Stamford, Conn., the maker of the painkiller OxyContin, agreed to pay $19.5 million to 26 states to settle off-label marketing allegations.

Since 1997, when the Justice Department began receiving funding earmarked for fighting health care fraud, the federal government has collected $11.87 billion in fines for various violations and returned the money to Medicare, Medicaid and other health care programs.

Critics of off-label marketing say drug makers continue to do it for one simple reason: profits. Even when drug makers are forced to pay huge fines, the amounts are small, compared with the money that can be made by promoting drugs for off-label uses.

In 2004, New York-based Pfizer, which has its research and development headquarters in Groton and New London, Conn., paid $430 million in fines to settle allegations that it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses.

David Franklin, a medical liaison who became a whistleblower against the company, said that even after the settlement - one of the largest ever in a health care fraud case - doctors told him that other pharmaceutical companies were still actively promoting their drugs for off-label uses.

"The $430 million penalty was widely referred to as a slap on the wrist," Franklin said.

Sales of Neurontin reached nearly $2.7 billion in 2003, a year before the fines, which settled allegations that Warner-Lambert - a company Pfizer bought in 2000 - flew doctors to lavish resorts and paid them big speaking fees to hype Neurontin.

Many of the cases begin with a lawsuit filed by a whistleblower such as Franklin. Under the federal False Claims Act, private citizens can sue on behalf of the government and receive a portion of fines in cases in which companies defraud the government, including cases in which Medicare and Medicaid are charged for these off-label prescriptions. Franklin received a total of $26.6 million in the Neurontin case.

Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications, said it is dangerous for pharmaceutical companies to promote non-approved uses for their drugs.

Doctors will use their judgment to decide what's best for their patients, including sometimes off-label prescriptions, but when drug companies promote those uses, it circumvents the FDA approval process and could lead to doctors prescribing drugs for uses that aren't safe or effective.