I am petitioning to have the iPLEDGE program removed permanently. iPLEDGE is a program in the United States put in place by the FDA. iPLEDGE was established in order to educate and prevent pregnancy due to birth defects while on the medication called isotretinoin, often known as an older brand name, called Accutane. Every patient is required to be enrolled from age 12 and up. Since iPLEDGE has been established, its rate of efficacy has not proven substantial, yet has increased much frustration. In fact, a study done by the Journal of the American Academy of Dermatology stated: "We found no evidence that iPLEDGE significantly decreased the risk of fetal exposure in FCBP (female patients of childbearing potential) compared to the SMART (system to manage Accutane-related teratogenicity) program." My plea is that this medication and the education on the effects of the medication, along with monitoring should be between the patient, prescriber, and pharmacist only. Users with female sexual organs must take a pregnancy test every 30 days and have it inputted into the system in a very prompt manner, or the patient will need to wait an additional 30 days to receive their prescription regardless of a negative test. Once the designee confirms a patients negative pregnancy test, the patient has 7 days to answer a set of questions regarding their method of contraceptive and what could happen if they become pregnant, as well as to pick up their prescription. If the designee, for whatever reason, is unable to fill out a negative pregnancy test in the proper timing, the patient will be denied by the pharmacy. Recently iPLEDGE had undergone an update to its system, however, due to this, patients across the United States have not been able to continue treatment. Designees and patients alike cannot login, forcing patients with the seven-day window to wait another month. Some in that position are able to login but unable to answer their questions. Still others are not even able to get this far, entirely delaying treatment. The American Academy of Dermatology (AAD) has commented: "For years, the AADA has worked with the FDA to make the iPLEDGE program less burdensome for patients. The challenges facing dermatologists and their patients is unacceptable and we’re calling on the FDA, the iPLEDGE administrator, and the program sponsors to support physicians and their patients. The AADA supports any efforts to streamline the iPLEDGE program while preserving patient safety and incorporating physician input. Our focus remains on working with the FDA, the iPLEDGE administrator, and the program sponsors to increase access to medications that will strengthen patient outcomes." Stopping the treatment causes a plethora of issues. Patients who take isotretinoin often have severe acne causing them to have mental and emotional pain, even to the extent of isolation from friends and social opportunities. Along with this, isotretinoin is a very serious drug that takes a toll on its users. Going through iPledge can extend the time of treatment because of its many inadequacies. You can read more on what the AAD says in these two letters to Syneos Health and the iPLEDGE sponsors and Atrizia Cavazzoni, the director of the Center for Drug Evaluation and Research at the FDA: AADA_urges_iPLEDGE_to_Delay_Comment_Letter_2021_Final_Sent.pdf (ctfassets.net)

AADA_Request_to_Temporarily_Halt_iPLEDGE_.pdf (ctfassets.net)

Please, stop iPLEDGE for good.

References:

https://doi.org/10.1016/j.jaad.2010.09.017​ 

www.dermatologytimes.com/view/aad-suggests-halting-ipledge-program​

www.aad.org/news/aada-disappointed-ipledge-transition