Healthy Skepticism Library item: 16579

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Publication type: news

Gullo K, Larkin C
Allergan Sues FDA to Market Off-Label Botox Uses (Update2)
Bloomberg.com 2009 Oct 2
http://www.bloomberg.com/apps/news?pid=20601103&sid=aWfiFb74XVt4

Full text:

Allergan Inc. is challenging a U.S. government rule that prohibits marketing its wrinkle-smoother Botox for unregulated uses, saying the policy restricts information that is needed for patients’ safety.

Doctors should get dosing guidelines and details of injection techniques to reduce risks when giving patients Botox for uses that haven’t been approved, Allergan said today. The drugmaker announced yesterday that it would file a court order enabling the distribution of such information. This is the first lawsuit challenging this aspect of the FDA’s marketing rules, according to the company.

Botox, a purified form of the deadly poison botulinum, paralyzes nerves to relax wrinkles and treat neurological disorders. In April, the Food and Drug Administration ordered all botulinum toxin products to beef up warnings about muscle weakness and implement programs to minimize risk. Most side effects are reported following treatment of arm and leg spasms, a use not approved by the FDA, and a neck-twisting disorder.

“One of the real dilemmas that we suffer from is the breadth of use of Botox,” Allergan Chief Executive Officer David Pyott told investors today on a conference call. “Unfortunately, the FDA tends to be one of the last agencies in the world from a time point of view to approve these new indications.”

Risk Management

Allergan is required as part of its new risk-management plan to warn about risks of off-label uses. The company said it should also be allowed to proactively provide information on benefits, dosing, patient selection and other information that can help doctors make appropriate treatment decisions.

The Irvine, California-based drugmaker fell 99 cents or 1.8 percent, to $54.96 at 4:02 p.m. in New York Stock Exchange composite trading. The shares gained 36 percent this year, outperforming a 2.7 percent increase in the 13-member Standard & Poor’s 500 Pharmaceuticals Index.

Almost 2.5 million Americans had Botox injections last year for cosmetic purposes, according to the American Society for Aesthetic Plastic Surgery. The drug, approved in 1991 for medical uses and in 2002 as a wrinkle smoother, became fashionable among aging celebrities as a nonsurgical way to appear younger.

Botox Revenue

Botox accounted for almost a third of Allergan’s revenue last year with $1.3 billion in sales, split between cosmetic and therapeutic uses. The drug is approved for treatment of two eye muscle disorders, excessive underarm sweating, and abnormal head position and neck pain caused by cervical dystonia.

“The outcome of this lawsuit won’t have an impact on sales,” said Douglas Ingram, Allergan’s executive vice president. “If we lost it, we would be at the status quo.”

The FDA declined in May to approve Botox to treat upper limb spasms in patients who have suffered a stroke, pending additional data and completion of the risk-management plan. The company also is in final stages of testing the drug as a treatment for migraines.

While doctors are free to prescribe any drug to treat illnesses regardless of FDA approvals, pharmaceutical companies are prohibited from promoting medicines for off-label uses. This violates the First Amendment of the U.S. Constitution and the federal Food, Drug and Cosmetics Act, the company said.

Preliminary Injunction

A copy of the complaint, filed in federal court in Washington, names the FDA and the Justice Department as defendants, said Caroline Van Hove, an Allergan spokeswoman. The company is asking for a preliminary injunction until resolution of the lawsuit, which it expects will take six to 12 months.

“The FDA does not comment on pending litigation,” said Karen Riley, an agency spokeswoman, in a phone interview today. Tracy Schmaler, a Justice Department spokeswoman, had no comment.

The FDA said in January that companies can give doctors copies of medical journal articles describing studies of products being tested for new uses as long as they don’t promote these uses without approval. Many doctors don’t have time to read studies and seek out the latest research on their own, Allergan’s Ingram said.

“ We’re convinced that physicians would benefit and patients would benefit from even more information,” he said today in a phone interview.