Healthy Skepticism Library item: 16585

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Rockoff JD
Allergan Suit Seeks to Lift Botox Curbs
The Wall Street Journal 2009 Oct 2
http://online.wsj.com/article/SB125444405169558079.html

Abstract:

Allergan Inc. filed a lawsuit against federal health officials late Thursday asserting that the government has violated its free-speech rights by barring the company from offering information about the unapproved use of its antiwrinkle drug Botox and other products.
Drug makers can’t market in the U.S. medicines for uses that haven’t been approved by the Food and Drug Administration, but doctors are free to prescribe drugs as they see fit. Companies can provide scientific studies and other accurate information to doctors about the so-called off-label uses upon request.
In its lawsuit, Allergan asked the U.S. District Court in Washington, D.C., to declare unconstitutional the law that prevents it from providing “truthful and important information” to doctors about off-label uses. Such off-label information could include guidelines on appropriate doses, describing patients most likely to benefit and proper techniques for administering drugs, the company said.
An FDA spokeswoman said the agency doesn’t comment about pending litigation.
The Washington Legal Foundation, an industry-supported think tank, and pharmaceutical company employees have challenged the federal ban on free-speech grounds. But drug makers have been reluctant to sue the FDA themselves.
If successful, the lawsuit could affect medicines far more potent than Botox. The ban on off-label promotion stems from a law, the Food, Drug and Cosmetic Act of 1938, intended to protect consumers from bogus and potentially harmful remedies.
Some 21% of drug use is off-label, and most occurs without scientific evidence supporting it, according to a 2006 study in the Archives of Internal Medicine.
Drug makers have paid billions of dollars in fines for promoting drugs for off-label uses. In September, Pfizer Inc. agreed to pay $2.3 billion for allegations that it promoted the painkiller Bextra and other medicines for unapproved uses.
The FDA has approved Botox’s cosmetic use to treat wrinkles between brows as well as various therapeutic uses. As much as a third of Botox’s sales could be off-label, said Ronny Gal, a Sanford C. Bernstein & Co. analyst, including treatment of cerebral palsy.
With $1.3 billion in sales last year, Allergan’s Botox is the Irvine, Calif., company’s top-selling product. It went largely unchallenged in the U.S. until this year, when Medicis Pharmaceutical Corp. began selling a competitor called Dysport. The FDA required the products to have a strong boxed warning cautioning about side effects.