Katrice Bridges Copeland used to defend pharmaceutical company executives when their companies were accused of fraud.
But when she saw that Pfizer, after being accused of fraud, had entered a third corporate integrity agreement with the government and paid $2.3 billion in fines to avoid being excluded from doing business with Medicare, Copeland said she was infuriated. She wrote a 63-page paper encouraging more effective measures to get companies to comply.
"That's not even a quarter of their profits," said Copeland, a law professor at Pennsylvania State University. "I was up in arms."
Government officials say they are, too, and they've talked about incorporating some of Copeland's ideas.
"That's a question we've been struggling with for the last couple of years," said Gregory Demske, assistant inspector general for legal affairs at Health and Human Services (HHS). "We recognize there's a problem."
If a company is excluded from doing business with the government, then medications sold only by that company will be unavailable to beneficiaries. But the fees associated with corporate integrity agreements haven't been enough to keep companies from bilking the government again, Copeland said.
"They're still going to make more in profits than they lose in fines," she said.
HHS officials are talking with those at the Justice Department and Food and Drug Administration to fix the problem, Demske said.
Most of the cases come from off-label marketing of prescription medications. For example, Pfizer was accused of marketing Bextra, a painkiller, for uses other than what the FDA had approved. Such uses constitute fraud because they take government money for purposes the FDA has not approved.
Instead of excluding a company from doing business with the government, Copeland said, authorities could exclude the drug from being marketed off-label.
HHS officials considered that, Demske said, but they needed to ensure that beneficiaries could get their medications. HHS is considering removing a company's patent rights as part of a government settlement.
Pfizer, Bristol-Myers Squibb and Abbott Laboratories did not respond to questions from USA TODAY.
"Imposing such a severe penalty on a person who had no knowledge of the wrongdoing at issue is manifestly unfair and unjust," said Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America.
Fraud fines, 1A
To see more of USAToday.com, or to subscribe, go to http://www.usatoday.com
Copyright 2012 USA TODAY, a division of Gannett Co. Inc.