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Allergan sues FDA for restricting off-label drug promotion

World News | October 04, 2009


Selina McKee

Botox-maker Allergan is taking the US Food and Drug Administration to court to challenge the regulator’s restriction on the off-label promotion of drugs which, it is claiming, is a violation of the First Amendment right to free speech.

More specifically, the Irvine, California-based firm has filed a ground-breaking “declaratory relief action” in the United States District Court for the District of Columbia seeking permission to “proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of Botox (botulinum toxin A) for certain ‘off-label’ therapeutic uses”.

As it stands, the law allows doctors to use their own medical judgement in prescribing drugs for unlicensed conditions, and Allergan points out that it is estimated around 20% of all scripts the US are for off-label indications, including serious conditions such as cancer and AIDS. In addition, it claims that federal, state and private health plans often pick up the tab for off-label drug uses, including the prescription of Botox - which is licensed for a variety of conditions such as wrinkles, certain eye disorders and excessive underarm sweating – for unlicensed uses such certain types of adult and juvenile spasticity.

However, despite this, federal law currently prohibits pharmaceutical companies from actively dishing out information to the medical community on the potential off-label uses of their medications “even when such information is accurate and complete,” the company says, and argues that this goes against the grain of freedom of speech.

“We believe that the inability to share such important information proactively with the medical community violates the First Amendment and potentially diminishes the quality of patient care,” explained Douglas Ingram, Allergan's Executive Vice President, Chief Administrative Officer and Secretary.

Safety issues
The move comes after the company was last month ordered by the US Food and Drug Administration to update the labels for Botox products and undertake a special risk management programme to educate doctors about the potential side effects of the drug, which can be life-threatening in the extreme. This includes speaking to physicians “in general terms” about certain off-label uses, but Allergan maintains it must be able to proactively provide “comprehensive information” about dosing guidelines and patient selection criteria, for example, without fear of legal recourse, so that it can ensure patients are being treated as safely and effectively as possible.

In March last year US regulators launched an investigation into the firm’s past marketing practices regarding the off-label promotion of its botulism-based products, which is still ongoing.

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