Healthy Skepticism Library item: 16573

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Publication type: news

Pierson R
UPDATE 1-Allergan says suit unrelated to U.S. Botox probe
Reuters 2009 Oct 2
http://www.reuters.com/article/marketsNews/idUSN0232442220091002

Abstract:

• Says suit vs FDA, DOJ unrelated to ongoing Botox probe

• Shares fall after news of bid to end sales restrictions

• Move comes despite stated “life threatening” Botox risk

Full text:

Allergan Inc (AGN.N) said its lawsuit against the federal government is aimed at lifting restrictions on promotions of its Botox anti-wrinkle drug for unapproved uses, and is not related to an ongoing U.S. probe of the company’s Botox marketing practices.

Allergan disclosed last year that federal prosecutors in Atlanta had begun a probe into its sales and marketing of Botox, the company’s flagship product with current annual revenue of about $1.2 billion.

“The case in that matter involves past practices” and investigations, company Chief Administrative Officer Douglas Ingram told analysts in a conference call on Friday.

By contrast, Ingram said a lawsuit filed by Allergan on Thursday against the U.S. Food and Drug Administration and Department of Justice is “forward-looking.” He said it is meant to lift FDA restrictions against promoting drugs for unapproved — or “off-label” uses.

Shares of Allergan were down 2.2 percent, following news of the lawsuit and the company’s vow during Friday’s conference call to try to overturn current government policy.

The FDA in April said Botox and rival injections must carry a strong warning about potential life threatening complications if the botulism toxin, which is injected at specific sites, spreads in the body.

The move came in response to reports of deaths and hospitalizations in adults and children treated with botulinum toxin for medical conditions other than approved cosmetic procedures.

Despite those highly publicized safety concerns, Allergan on Thursday filed its lawsuit in U.S. District Court in Washington, D.C., asking that the company be allowed to actively share with doctors “truthful, accurate and complete” information on potential off-label benefits of Botox.

Allergan said the current restrictive policy of the Justice Department and FDA violates the company’s First Amendment right to free speech and is inconsistent with the Federal Food, Drug and Cosmetic Act.

Most doctors use Botox to moderate facial wrinkles but the company — and some doctors on their own — have studied the botulism toxin for a variety of other uses, including spasticity , migraine headaches and overactive bladder.

A significant percentage of Botox sales are for such unapproved uses. Although doctors are allowed to use any approved prescription drug for any ailment, drugmakers are not allowed to actively promote such unapproved usages.

Shares of Allergan were down $1.25 to $54.70 in early afternoon trading on the New York Stock Exchange.