Healthy Skepticism Library item: 10087

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Lavoie D.
Cracking down on off-label marketing
Associated Press 2007 May 11
http://www.nj.com/business/ledger/index.ssf?/base/business-0/1178866605289360.xml&coll=1

Full text:

U.S. District Court Judge Patti Saris had seen cases like this be fore, and she was fed up.

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

“You can’t thumb your nose at the FDA,” Saris said. The judge, who sits in Boston, sentenced Schering Sales and its parent company, Kenilworth-based Schering- Plough, earlier this year to pay $435million to settle allegations 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.

Although doctors are free to prescribe drugs for uses that have not been approved by the FDA, 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.

Over the past decade, federal prosecutors across the country have aggressively targeted drug companies, including Pfizer, Astra Zeneca Pharmaceuticals, and Eli Lilly, for illegal marketing activities. Just this week, Purdue Pharma, the maker of the painkiller OxyContin, agreed to pay $19.5million to 26 states to settle off-label marketing allegations. In a related development yesterday, OxyContin and three of its current and former executives pleaded guilty to misleading the public about the drug’s risk of addiction and will pay $634.5million in fines.

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

In 2004, Pfizer paid $430million in fines to settle allegations it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses. David Franklin, a medical liaison who became a whistle-blower against the company, said that even after the settlement — one of the largest ever in a health-care fraud case — doctors told him other pharmaceutical companies were still actively promoting their drugs for off-label uses.

Sales of Neurontin reached nearly $2.7billion in 2003, a year be fore the fines, which settled charges 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 whistle-blower like Franklin. Under the federal False Claims Act, private citizens can sue on behalf of the government and receive a portion of fines in cases where companies defraud the government, including cases in which Medicare and Medicaid are charged for these off-label prescrip tions. Franklin received a total of $26.6million in the Neurontin case.

Some of the biggest pharmaceutical companies — including Schering-Plough, Serono Laboratories and Pfizer — have been prosecuted in Boston, where the U.S. Attorney’s Office has one of the most aggressive health-care fraud units in the country. Boston gained a reputation after a record $875million fine was handed out against TAP Pharmaceutical Products in 2001 to settle allegations it inflated prices and bribed doctors to prescribe its prostate cancer drug Lupron.

Pharmaceutical companies say they have put strict programs in place over the past few years to train their employees to comply with the FDA regulations.

Last month, Pfizer agreed to pay fines totaling $34.7million for two subsidiaries accused of offering a subsidiary of a pharmacy benefit manager a kickback to recommend company drugs and for promoting the human growth hormone product Genotropin for nonapproved uses. In both the Neurontin and Genotropin cases, the illegal marketing activity took place before the units were acquired by Pfizer.

“Pfizer’s long-standing policy is that we don’t promote our products for off-label uses — period,” spokesman Bryant Haskins said.

Prosecutors say the law is clear: Pharmaceutical companies cannot promote off-label uses for their drugs in any way, either in advertis ing to consumers, brochures handed out to doctors and even during discussions between their sales representatives and doctors. One exception is if a drug company receives an unsolicited letter from a doctor asking about a drug, the company is allowed to respond with a letter that includes a description of off-label uses.