A federal appeals court last week refused to revive a lawsuit in which a former Pfizer employee alleged the company promoted off-label use of its Lipitor cholesterol pill. In doing so, however, the court also raised a question about the extent to which drug makers may be held responsible for causing federal health programs, such as Medicare and Medicaid, to overpay for a medicine.

Here’s the back story: Jesse Polansky, a former Pfizer medical director, contended the drug maker illegally marketed the best-selling pill by ignoring National Cholesterol Education Program guidelines. The guidelines stated the cholesterol-lowering drug should be prescribed only to certain patients, but Pfizer knowingly widened the market, according to his lawsuit, which was originally filed in 2004.

In doing so, he charged that Pfizer violated the False Claims Act. That’s because government health care programs generally do not reimburse prescriptions for so-called off‐label use, which refers to promoting a drug for uses not approved by regulators. Polansky contended that Medicare, Medicaid, and other government programs were essentially duped into paying for Lipitor prescriptions.

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The dispute ricocheted through the legal system all these years as Polansky pressed his case despite various setbacks in lower courts. However, the US Court of Appeals for the Second Circuit decided that Pfizer did not illegally market the pill because those guidelines – which appeared in the Lipitor product labeling – were recommendations and did not carry the force of law.

In tossing the case last week, the appeals agreed with a lower court, which wrote that “we cannot accept (Polansky’s) theory that what scientists at the National Cholesterol Education Program clearly intended to be advisory guidance is transformed into a legal restriction, simply because the Food and Drug Administration has determined to pass along that advice through the label.”

Pfizer released a statement saying it was pleased that the court decided that its marketing was “consistent with the FDA-approved label for Lipitor.” For his part, Polansky said he is “disappointed with the decision, both the narrow ruling and the gratuitous broader commentary. I feel obligated to seek further review.”

The commentary to which he referred actually raised an intriguing issue. In a section of the decision, the appeals court actually expressed doubt about whether off-label marketing can ever be used as a reason for charging a drug maker with violating the False Claims Act. That’s because doctors are free to prescribe medicines for any use, and pharmacies and patients are generally unaware of those decisions.

The appeals court wrote that there is “an important distinction between marketing a drug for a purpose obviously not contemplated by the label (such as growing hair or curing cancer in the case of Lipitor) and marketing a drug for its FDA‐approved purpose to a patient population that is neither specified nor excluded in the label.”

In other words, drug makers may not be held responsible if Medicare, for instance, pays for a drug that is prescribed for an unapproved use unless the labeling expressly specifies that certain patients should not be prescribed that drug. This may seem like parsing, but some attorneys believe the decision may help clarify an unanswered question about the extent to which drug makers may be held liable.

The decision does provide insight into a “question that we have been wrangling with,” wrote the FDA Law Blog, which tracks regulatory matters and is published by Hyman, Phelps & McNamara, a law firm that represents drug makers. “That is, can the government’s theory of False Claims Act liability be predicated solely on a manufacturer’s off-label promotion of its product? The answer seems to be no.”

The FDA, you may recall, can prohibit drug makers from distributing off-label information. But the agency has faced pushback after the same appeals court in 2012 overturned a criminal conviction of a sales rep for promoting off-label uses. The court ruled his speech was protected, since the information was truthful and not misleading.

And so, the blog rightly points out that it will be important to see if other courts follow the same line of thinking. For now, the blog adds “we are skeptical that any court will be able to resolve the serious constitutional issues raised by FDA’s policies (concerning) off-label marketing by applying the distinction” made by this appeals court.

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  • Seeing as doctors can prescribe drugs for any use, and drug makers will probably never be held liable for violating the False Claims Act, the loop is closed on this Off-Label Belief System.
    What’s even better is that Hippa guarantees that loved ones can’t find out anyway.

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