Clay J. Cockerell, M.D., president of the American Academy of Dermatology Association (Academy) recently released a statement: “Safety of Isotretinoin Patients Put at Risk by March 1 Start Date for iPLEDGE Program.”
According to the statement, the 15,000 physician members of the American Academy of Dermatology Association (Academy) urge the US Food and Drug Administration (FDA), and the sponsors and vendor for the iPLEDGE program, to immediately postpone the March 1, 2006, start date of this program until significant changes can be made to ensure patient safety. Dermatologists across the country are reporting numerous flaws in the iPLEDGE program that are interfering with patient care and could affect patient safety.
“Under the direction of the FDA, the Isotretinoin Product Manufacturers Group (IPMG) and their chosen iPLEDGE vendor, Covance, have designed a mandatory, risk management system that tracks registered prescribers and all registered patients to ensure that women of childbearing potential do not become pregnant while taking this medication.
“Several very serious concerns regarding the implementation of iPLEDGE have emerged since the FDA approved the program in August 2005. Although the Academy has repeatedly pointed out the importance of addressing these concerns so that the program works as intended and is not a failure, many issues remain unaddressed. Unfortunately, extending the effective date from Dec. 31, 2005, to March 1, 2006, has not sufficiently resolved these issues.
“Patient safety while taking isotretinoin depends on the careful oversight of the prescriber. The Academy believes that the iPLEDGE program, as it stands right now, is too cumbersome for both the patient and the prescriber. To circumvent the iPLEDGE program registration process, patients may seek other avenues to receive the medication, such as purchasing it off the Internet, which removes the safeguards in place when the patient takes the medication under a prescriber's care. Problems with the program may also lead to a disruption of care for patients currently taking this medication, or lead to delays in the start of therapy for qualified patients.
“Since its FDA approval nearly 25 years ago, members of the Academy have had considerable experience with isotretinoin. Our members and their patients experience firsthand the significant - and in most cases, life changing - benefits that isotretinoin provides for individuals with severe acne and some rarer dermatologic conditions, as well. At the same time, the Academy recognizes the seriousness and importance of careful prescribing and patient education to ensure that women of childbearing age who are taking the medication do not become pregnant.
“We believe that the iPLEDGE program should not become effective on March 1, 2008, or at any time in the future unless the Academy's concerns are fully resolved. Forcing this program onto the public would not promote the health, safety, and welfare of isotretinoin patients and would be detrimental to the practice of dermatology in this country.”
