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If off-label marketing is 'speech,' why even have the FDA?

If off-label marketing is 'speech,' why even have the FDA?

Picture of Martha Rosenberg

It has always been legal for U.S. doctors to prescribe drugs for off-label uses but marketing of off-label uses has been illegal. In August, U.S. District Judge Paul A. Engelmayer ruled that the First Amendment allows a drug company to "engage in truthful and non-misleading speech promoting the off-label use" of drugs and that the FDA cannot bar such "speech." The ruling, pertaining to the drug Amarin, which targets high triglyceride levels, is likely to be appealed and only applies to the 2nd U.S. Circuit Court of Appeals, which includes New York, Connecticut and Vermont. But patients had better beware.

Off-label marketing is irresistible to Big Pharma because it saves years and millions spent on clinical trials which may not assure FDA approval anyway. It allows drug companies to circumvent the pesky and slow FDA altogether and get on with the business of making money-- bringing their sales pitch to doctors and patients directly. Almost all major drug companies—GSK, Eli Lilly, Abbott, AstraZeneca, Pfizer, Johnson & Johnson, Amgen, Allergen, Bristol-Myers Squibb, Cephalon, Novartis and Purdue (which makes Oxycontin)––have agreed to huge settlements which include charges of off-label marketing.

In court-released confidential memos, Pfizer (then Parke-Davis) admits why it chose to off-label market Neurontin (only approved for postherpetic neuralgia and adjunctive seizure therapy) for the unapproved indication of bipolar disorder. “The U.S. market for Bipolar Disorders is an attractive commercial opportunity that warrants clinical development of Neurontin. Based on the current patent situation, an investment in full clinical development is not recommended at this time since completion of two pivotal trials and regulatory filing and approval would occur close to patent expiration,” says the memo. Translation: It would take too long to get legal approval—our patent would expire. Instead, says the memo, “it is recommended to implement only an exploratory study in outpatients with bipolar disorders with the results highlighted through a peer reviewed publication.” Translation: Let’s not do the studies and plant some info in medical journals that looks like we did.

 Pfizer paid a $430 million fine and signed a corporate integrity agreement for off-label marketing of Neurontin which was linked to wrongful deaths and suicides. But that did not stop Pfizer from off-label marketing Lyrica, sometimes called "son of Neurontin," soon afterward. Who can say incorrigible?

 Nor did Eli Lilly's guilty plea in 2009 to the off-label promotion of the antipsychotic Zyprexa deter it from requesting permission from the FDA to market Zyprexa to children three months later. The FDA said---yes! At the same time, Pfizer and AstraZeneca also requested permission to market their antipsychotics, Geodon and Seroquel respectively, to kids though both agreed to off-label marketing those exact drugs months later.

 Another off-label marketing scheme centered around the selective estrogen receptor modulator Evista. Eli Lilly, its manufacturer, had noted fewer incidences of breast cancer in an Evista trial and wanted to market it not just for its approved treatment of prevention of osteoporosis but for prevention of breast cancer. A group of doctors told Lilly the anticancer marketing claims were “an egregious stretch” and that Evista's high risk of stroke canceled out any anticancer benefits.

 Undaunted, Lilly armed 1000 of its drug reps with an off-label Evista sales plan to sell the unapproved use of breast cancer prevention. Drug reps were told to hide a disclosure page that said, “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established,” and “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,” according to the Department of Justice.

 Lilly was charged with a violation of the Food, Drug, and Cosmetic Act and ordered to pay a $36 million settlement for the off-label marketing. But Evista did receive approval to reduce the “risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.” The problem was the drug, marketed so freely for off-label uses, was far from safe. Prescribing information warned "Serious and life-threatening side effects can occur while taking EVISTA" and ads warned about “death due to stroke." Its effectiveness was also not impressive. Patients were warned that Evista doesn’t “completely prevent breast cancer,” and “Breast examinations and mammograms should be done before starting Evista and regularly thereafter.”

 Clearly, forgiveness is cheaper than permission for drug makers who consider such settlements the cost of doing business. But are drug sales pitches really "speech?" Can a "truthful and not misleading" determination really be made by the for-profit company selling the product? If drug companies' product claims are protected under the First Amendment and they can sell directly to doctors and patients why even have an FDA?

 Over 50 years ago, Big Pharma was also annoyed with the slow-paced FDA whose efforts to ensure drugs were safe cut into profits. One company even complained to an FDA official's bosses that she was a petty bureaucrat. The company made thalidomide.

Comments

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How strong are the chances this will go to the Supreme Court and wipe out the main legal argument for whistleblower lawsuits? Once again, Martha Rosenberg is on the cutting edge of coverage on important pharmaceutical industry issues.

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This is an excellent piece, and needs broad action. The industry is nothing if not relentless in pushing dangerous drugs. No wonder it has the biggest lobby in Washington and spends more dollars than any other industry - it peddles poisons, mingled in with some lifesaving drugs.
How dare the Obama Administration sit by and not only indict not one individual from Big Pharma but not even say that they might, as they are saying right now with Wall Street executives? And to add insult to injury, the President has just nominated Cahill to run the FDA - a person with deep financial connections to the pharmaceutical industry.
Let the buyer beware has never been more true - whatever happened to the FDA that actually acted heroically against thalidomide? It's not about the public health, I guess but about the private purse.

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