FDA Warns Allergan About Claims

Allergan Inc. improperly promoted its Botox neuromuscular treatment to doctors by overplaying evidence of the product’s benefits, government regulators said in a formal warning letter to the Irvine company.

The company’s promotional materials also failed to inform doctors of the risks associated with Botox, the Food and Drug Administration said in the letter dated Aug. 22.

The letter said the FDA has complained about Botox marketing at least five times since 1998. Catherine Miller, acting chief of the FDA branch that regulates promotion and advertising of products such as Botox, urged Allergan to “take prompt action to correct the violations in the noted materials and all promotional materials for Botox that contain violations.”

Botox, a purified form of one of the deadliest known poisons, botulinum, is approved for eye muscle disorders and to treat muscular pain related to a condition called cervical dystonia. Doctors also use the product in plastic surgery procedures to minimize wrinkles.

The drug has provided a big financial boost for Allergan, accounting for 15% of the company’s sales last year. Sales climbed 29% to $144 million in the first six months this year.

Company officials said Allergan had stopped using most of the materials cited by the FDA, and any remaining materials have been pulled. The repeated FDA complaints--two of them formal warning letters--reflect the length of time the product has spent on the market, said Christine Cassiano, a spokeswoman for Allergan.

“You are talking about a product that has been used in the U.S. for 12 years now, so there is a lot of material that is going to have been created,” she said. “Any time we get a request from the FDA, our first concern is to make sure we comply.”

The FDA sends hundreds of warning letters to companies each year and although only a small number result in significant agency action, letters can be the last notice before the FDA takes steps such as seeking civil fines.

The letter said Allergan bolstered the case for Botox’s benefits by featuring data from animal and lab studies without making it clear these studies don’t have any proven significance to patients.

The promotional materials failed to include adequate mention of the drug’s risks, which in very rare instances have included serious injury and death, the FDA said.

Allergan’s stock closed at $72.30, up 5 cents a share, on the New York Stock Exchange.