The Chicago Sun-Times on Monday examined the online FDA tracking database iPledge, with which all people taking Roche's acne drug Accutane much register to receive their prescriptions (Ritter, Chicago Sun-Times, 8/21).
FDA on Dec. 30, 2005, began to register physicians, prescription drug wholesalers, pharmacists and women into iPledge after an FDA advisory committee in March 2004 recommended the program.
Under iPledge, women are required to submit two negative pregnancy tests before they can receive an initial prescription for Accutane, known generically as isotretinoin, and women must undergo a monthly pregnancy test before each refill, along with fulfilling other conditions intended to reduce the chance of pregnancy (Kaiser Daily Women's Health Policy Report, 3/2).
In addition, women must agree to use two forms of birth control at the same time or to abstain from intercourse for one month prior to treatment with isotretinoin, during treatment and for one month after treatment has ended, according to FDA.
Women also must sign a document to acknowledge that isotretinoin can increase risk for birth defects, depression and suicidal thoughts (Kaiser Daily Women's Health Policy Report, 2/24).
About 165,000 people have registered with iPledge, which is administered together with companies that sell the drug. However, critics say that iPledge is onerous and poorly administered.
According to the Sun-Times, Sen. Dick Durbin (D-Ill.) and seven other senators, in a recent letter to FDA wrote, "Our offices continue to receive numerous complaints from doctors, patients and pharmacists about the inflexible and confusing requirements that have denied access to the drug to thousands of qualified patients."