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FDA Gives in to Drug Manufacturer in Off-Label Marketing Suit

— December 28, 2015

Last week the US Food and Drug Administration (FDA) lost another tooth, and the pharmaceutical industry won another battle in its ongoing effort to roll back safety regulations that impinge on its profit margin.

The regulatory agency capitulated to drug company Pacira Pharmaceuticals’ demand that it revoke restrictions it had placed on Pacira’s marketing of its pain medication Exparel. Exparel had been tested and approved for the treatment of pain following bunion and hemorrhoid removal by applying it to the site of the surgery. Pacira had been marketing Exparel to physicians as an effective pain treatment for a wide array of surgeries.

In September, the FDA issued a formal warning to Pacira to stop such “off-label” marketing. The drug company, based in Parsippany, New Jersey, responded by filing a lawsuit claiming the FDA’s regulation violated its First Amendment right. Pacira argued that its off-label marketing was protected free speech as long as the information it provided was truthful. Giant drug companies Pfizer, Johnson & Johnson, GlaxoSmithKline, Novartis and others filed amicus curiae briefs for the case, making clear that that the pharmaceutical industry as a whole was watching the Exparel case closely. .

In support of its First Amendment claim, Pacira relied in part on a 2012 US Second Circuit Court case, U.S. v. Caronia, in which the court ruled that a sales representative of Orphan Medical was exempt from prosecution for off-label marketing because the information he provided was truthful.

The FDA’s withdrawal of its restrictions on Exparel could be interpreted in two ways. On the one hand, because the agency stipulated that its decision applied only to the specific case of Exparel, it may be that the FDA settled in order to prevent a court ruling that could have had more far-reaching implications. On the other hand, the FDA’s capitulation to Pacira and its free-speech claim may signal a new willingness to bend on the matter of off-label marketing (which can include direct marketing to consumers). In either case, though, the Exparel case, when considered in light of the Caronia case, indicates a tipping of the judicial and regulatory scales in the favor of Big Pharma.

From a broader perspective, this case amounts to one more round fired in an unchecked corporate assault on the democratic institutions of our country. As we watch the courts and regulatory agencies bend to the will of corporate power, with former corporate lawyers wearing judge and justice’s robes and heading up agencies like the FDA, we must recognize that our government is no longer answerable to the public will and no longer functions in the public interest. And as we endure another billion-dollar presidential election, we must draw the painful conclusion that whatever hope we have of determining the shape of our lives and our future, it does not lie within the system. The system belongs to those whose incentive is profit, and whose profit comes at our expense.

Source: World Socialist Web Site

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