Exit Accutane: Derms' reactions mixed as Roche pulls long-standing remedy

August 1, 2009

Dermatologists' reactions to Hoffman-La Roche's decision to discontinue its once-popular acne drug Accutane (isotretinoin) run the gamut. Some express disappointment or surprise; others marvel that the drug survived as long as it did.

Key Points

National report - Dermatologists' reactions to Hoffman-La Roche's decision to discontinue its once-popular acne drug Accutane (isotretinoin) run the gamut. Some express disappointment or surprise; others marvel that the drug survived as long as it did.

"If there were no isotretinoin available, it would be a huge step backwards for dermatology and patients," says Amy Forman Taub, M.D., director of Advanced Dermatology, Lincolnshire, Ill., and assistant clinical professor of dermatology, Northwestern University, Chicago.

Roche's statement also blames "high costs from personal-injury lawsuits that the company continues to defend vigorously."

Further, the drug was the subject of the cumbersome and widely criticized federal iPLEDGE registry program, launched in 2006 to guard against isotretinoin-related birth defects.

Generic competition also has been significant. A June 26 report from RBC Capital Markets estimates Accutane's final market share at 3 percent. Accutane's exit leaves Claravis (Teva/Barr) with 54.8 percent of the isotretinoin market, followed by Amnesteem (Mylan/GenPharm) and Sotret (Ranbaxy), each with 22.8 percent.

"Teva took a price increase in late September," the report states. With branded Accutane unavailable, "It is very likely we will see additional price increases."

Dermatologists contacted by Dermatology Times generally accept Roche's rationale for discontinuing Accutane.

Guy Webster, M.D., says, "I'm certain it was a combination" of legal and economic issues that killed the drug.

"If it had been worth it to Roche, they'd have stayed in the game," he says.

"It's a good business decision for them, and no surprise," says Dr. Webster, founder and past president of the American Acne & Rosacea Society.

Over the years, the Food and Drug Administration has added warnings to Accutane labeling regarding the drug's association with IBD, depression and suicide. Hundreds of lawsuits have been filed against Roche.

Attorney Michael Hook, a Pensacola, Fla., lawyer who has filed more than 600 cases charging that Accutane triggers IBD, says lawsuits unquestionably played a role in Roche's decision.

To date, Mr. Hook has tried and won six cases, earning judgments for clients ranging from $1.78 million to $10.5 million. All told, published accounts estimate that juries have awarded $33 million to patients who blame Accutane for their IBD.

Mr. Hook also has filed more than 100 similar cases against makers of generic isotretinoin.