And since 1991, the use of Accutane has increased without a significant effect on pregnancy rates, the company observes. "The number of pregnancy reports has not increased appreciably during this period of greater Accutane use," Hoffmann-La Roche says.
But company officials have begun taking additional action. In February, Hoffmann-La Roche began to distribute pregnancy tests to doctors who prescribe the drug. And in June, the company began implementing a "targeted" awareness program, aimed specifically at women of childbearing age.
That's not surprising, considering that Accutane is Hoffmann-La Roche's second largest revenue generator. At the meeting, the company will also ask the committee members to endorse a new once-a-day formulation meant to make the dosing schedule more convenient for patients.
For its part, the FDA is also looking to ask its expert advisory committee whether additional warnings are needed to outline other potential side effects of the medication, such as depression and psychosis.
But before the FDA takes any action, it will have to overcome professional objections. Further restrictions are opposed by the American Academy of Dermatology (ADD), which is concerned that they would make Accutane difficult for patients to obtain.
"Since the product's introduction in 1982, Accutane has proven to be the only medication that safely and effectively controls cystic acne, the most serious form of this skin disease," says Richard Scher, MD, president of the ADD. "Education, not regulation, is the key to safe use of this drug to protect women of childbearing age."