Citing a significant loss of market share, Roche announced in June that it will cease manufacturing the retinoid Accutane, but dermatologists say that the company's pullout will not affect patients' access to the drug and will not have any impact on the risk management program known as iPledge.
The move does not reflect isotretinoin's safety or efficacy, said Dr. Stephen P. Stone, chairman of the American Academy of Dermatology's task force on retinoids. It appears that “this decision was financial and did not have anything to do with the perceived safety of the drug or the perceived willingness of dermatologists to use the drug,” said Dr. Stone in an interview.
In a statement, Roche noted that generic competitors now own the market for prescription isotretinoin. Accutane has less than a 5% share for the acne therapy, said the company.
The company “has been faced with high costs from personal injury lawsuits that the company continues to defend vigorously,” according to Roche.
Accutane was first marketed in 1982; the initial round of suits mostly alleged the drug was associated with a potential for depression and suicide. More recently, at least 500 suits have been filed alleging that Accutane causes irritable bowel disease.
The generic companies aren't likely to skirt future litigation, said Dr. Stone, a past AAD president and professor at Southern Illinois University School of Medicine in Carbondale.
A spokeswoman for one of the generic manufacturers, Barr Laboratories Inc., said that Barr intended to continue making and distributing isotretinoin.
Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y., said in an interview that he agreed that plaintiffs' suits were likely to continue. But, he said, isotretinoin “is still a miracle drug” for acne and that he would not expect dermatologists to suddenly stop using it. He had already switched to using generic forms, partly because insurers made it less attractive for patients to use the brand, but also because he views them as largely equivalent, he said.
Dr. Stone, on the other hand, said he believed that iPledge had been responsive to dermatologists' complaints. He disclosed that he is on the scientific advisory board for iPledge.