“There’s been a change of paradigm,” Pfizer scientist James Christensen told the Wall Street Journal. “The new school of thought is, ‘If you find the patients that the drug will work in, and if you see enough benefit, we will find a way to get this to market.’”

These “targeted drugs” or “niche drugs” are oftentimes accompanied by a hefty price tag. For example, in the case of Xalkori, a year’s supply will run over $115,000. Similar sticker shock is tied to Roche’s melanoma drug Zelboraf (vemurafenib), which is priced at $56,400 for 6 months of treatment.

While there is nothing nefarious about a drug company reaping the monetary benefits of the economic supply and demand curve, there is heightened potential for fraud with hyper-specific FDA drug labels. Specifically, a narrow FDA-approved label provides drug companies with the proverbial “camel’s nose in the tent.” In other words, once a drug has been blessed by the FDA for a subset of the patient population, wayward drug companies will, inevitably and illegally, expand their marketing efforts to capture the rest of the patient population. This scenario has multiple off-label case recoveries over the past decade.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.

According to one news source, government investigators are especially interested in “uncompleted clinical studies that may be used to support off-label use,” and, in particular, “documents pertaining to a clinical study being conducted by to Mathias Rummel, who is the head of hematology at the University Hospital in Giessen, Germany.” This comes on the heels of recent announcements that the U.S. Justice Department is looking to expand its investigations into overseas pharmaceutical research studies, in order to uncover clinical trial fraud.

“Oftentimes enticed by lowered regulatory hurdles, pharmaceutical companies are increasingly flocking to foreign researchers to study the unapproved uses of their products,” said Nolan & Auerbach partner and former Taxpayers Against Fraud president Jeb White. “When beneficial preliminary data emerges from these studies, the results seep their way into paid speaker presentations and the promotional arsenals of pharmaceutical sales representatives. The end result is that off-label data is promoted to health care providers, outside the watchful eye of the U.S. Food & Drug Administration.”

Only time will tell if Cephalon was engaged in this international end run around the FDA. However, the message should be clear to the pharmaceutical industry that illegal off-label promotions, wherever their origin, will not be tolerated in the United States. Nolan & Auerbach, P.A. partner Ken Nolan wrote about Pharmaceutical Research Subcontractors in the October 2003 issue of Contract Pharma.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.

Further focusing on the off-label use of antipsychotics in nursing homes, the OIG determined that 83 percent of Medicare claims for atypical antipsychotics for these residents were associated with off-label use; 88 percent were associated with the condition specified in the FDA boxed warning.

So why are so many nursing homes turning a blind eye to the antipsychotics’ black box warnings? What is pumping this water uphill? Could it be companies marketing off-label? This OIG report comes on the heels of Congressional scrutiny and a chorus of legal actions from State Attorney Generals, accusing the drugmakers of improperly marketing antipsychotics.

Some off-label marketing schemes regularly influence the prescribing habits of physicians. While the coffers of pharma companies fill with tainted funds, patient safety and government healthcare programs suffer.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.

These successful actions dispelled the misconception that off-label marketing only occurs when marketing materials explicitly promote an unapproved use.

When a drug company details pediatricians or it corrals pediatricians into a room to tout the benefits of its drugs, it is implicitly stating that its products are approved for the doctors’ patient population. If, however, the products have not been approved for use in children and the company fails to share this information with the audience, there is likely a violation of the False Claims Act. In other words, half truths are considered “false” when it comes to off-label marketing.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.

The price tag to settle the civil allegations was $38 million. The criminal settlement required Kos Pharmaceuticals to ink a $3 million check, to enter into a deferred prosecution agreement, and to agree to the filing of a criminal information charging the company with one count of conspiracy to violate the anti-kickback statute.

Noticeably, the doctors who accepted the bribes were not held accountable. “As long as dishonest doctors are willing to be bought, drug companies will be able to bribe their way into America’s medicine cabinets,” said Nolan & Auerbach partner Jeb White. “We need to recognize that it takes two to tango in the underworld of pharmaceutical kickback schemes.”

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.

In an article, the investigator for the Natrecor trial, Dr. Robert M. Califf, a Duke cardiologist, said that “once again, small studies give us the wrong answers”, referring to previous small studies which suggested that Natrecor was effective. [See article in The International Herald Tribune (November 17, 2010) “The uncertainties of clinical testing; The case of a heart drug shows how small studies can lead to misdirection.”]

The article pointed out that “Cardiologists have similar questions about the effectiveness of Zetia, an eight-year-old cholesterol drug that Dr. Califf is also studying and which has been beset by questions about whether it improves heart health.” Zetia is widely accepted as  modestly reducing bad cholesterol and the significantly reducing L.D.L., but the article asserts, studies so far have failed to demonstrate a cardiac benefit to the drugs. It would be a disservice to patients if this drug were marketed off-label as having a benefit in stroke or heart failure for instance,without FDA-approval. Other pharma companies have promoted cholesterol and blood pressure drugs as having a class effect, without the benefit of the indication.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.

Prior to the sentencing hearing, the government filed a sentencing memorandum, detailing the allegations. According to the government’s memo, Allergan entered into a co-promotion agreement with a pharmaceutical company that had an FDA-approved headache drug, with the underlying goal of promoting Botox to neurologists who were customers of the other company.

“As a result of this unlawful off-label marketing scheme, Botox sales skyrocketed,” the court document said. By 2007, for example, the medical uses of Botox had annual sales of more than $500 million, with up to 80 percent from unapproved uses, primarily headache, pain and spasticity, the government’s document said.

The government began investigating Allergan’s marketing efforts after Nolan & Auerbach’s clients filed a qui tam action against the company.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.

While not intervening in this qui tam action, the Justice Department submitted its Statement to clarify the legal basis for an FCA claim predicted on allegations of off-label marketing by pharmaceutical manufactures. First, it stressed that claims for payment of items or services that are not eligible for reimbursement by federal health programs are “false claims.” Second, the Justice Department argued that a drug manufacturer may cause a provider to submit a false claim for reimbursement if that false claim was a reasonably foreseeable consequence of the drug manufacturer’s conduct. Third, the Government maintained that the identification of specific false claims is not an absolute prerequisite to satisfying the heightened pleading requirements of the FCA. According to the Statement, “So long as the complaint as a whole is sufficiently particular to strengthen the inference of fraud beyond possibility, a court may conclude that [the pleading standard] is satisfied.”

Notably, in this case, Pfizer had argued that a subsequent FDA-approved use absolved the company of any False Claims Act liability. The Government responded: “If a claim was false when it was submitted in 2004, a label change five years later does not transform that false claim into a reimbursable one. To hold otherwise would be to render federal health care program restrictions on coverage meaningless.”

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.

While health care providers can prescribe drugs for anything they see fit, it is illegal for drug companies to promote their drugs for uses not approved by the FDA. In this case, the whistleblowers, former Wyeth sales reps, maintained that they were encouraged to promote this drug for heart, lung, liver and pancreas transplants, even though the FDA had only approved the drug for kidney transplants.

Notably, the federal and state governments initially declined to intervene in this qui tam action. However, because the whistleblowers were able to move the case forward and piece together additional evidence of wrongdoing, the governments decided to take a second look.

Pfizer could be in violation of a corporate integrity agreement it signed a year ago, when it settled another FCA action for $2.3 billion, quieting similar claims of off-label promotions.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.