iPLEDGE REMS Program for Isotretinoin Products
The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. The goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. It is a “shared system” REMS, meaning that it includes all FDA-approved isotretinoin products. It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used.
In an effort to provide timely isotretinoin information to prescribers, pharmacies, patients, and distributors, the FDA will post any related updates on isotretinoin and the iPLEDGE REMS on this page.
Please see the iPLEDGE REMS website, for up-to-date and detailed information about the program.
FDA notified the isotretinoin manufacturers that they must modify the iPLEDGE REMS to minimize burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin. FDA is requiring isotretinoin manufacturers make the following changes to the iPLEDGE REMS:
- Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory.
- Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. As of November 7, 2023, all pre-treatment pregnancy tests must be performed in a medical setting (e.g., office, laboratory).
- Remove the waiting period requirement (also referred to as the “19-day lockout”) for patients if they do not obtain isotretinoin within the first 7-day prescription window. Before initiating isotretinoin treatment, a repeat confirmatory pregnancy test must be completed in a medical setting (as described above) without any required waiting period.
- Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes (and associated data collection) for each pregnancy.
- Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment.
In making this determination, FDA evaluated the iPLEDGE REMS and considered advice from the March 2023 Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meeting as well as public feedback. FDA has considered the impact of these changes, collectively, and determined the modifications will minimize burden for health care providers, patients, and pharmacists while continuing to ensure the benefits outweigh the risk of embryo-fetal toxicity (life-threatening severe birth defects).
The isotretinoin manufacturers are required to submit to FDA their proposed REMS modification 6 months from the date of the letter (November 30, 2023). While we work to formalize these changes, FDA continues to exercise enforcement discretion regarding pregnancy testing requirements as described in our October 13, 2023 update.
View the iPLEDGE REMS Modification Letter Template (PDF - 204 KB)
iPLEDGE Update (October 13, 2023)
Following the end of the COVID-19 Public Health Emergency, accommodations for certain requirements of some REMS programs were subject to an 180 day ‘wind down’ period that will end on November 7, 2023. After November 7, FDA is aware that patients’ access to isotretinoin may be adversely impacted by reinstating the requirement that pregnancy tests be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. To address this concern, FDA continues to exercise enforcement discretion with respect to certain requirements. Namely, FDA does not intend to object if prescribers:
- Assess a patient’s pregnancy status using pregnancy tests that are not performed in a CLIA-certified laboratory
- Rely on the patient to perform home pregnancy tests and report the dates and results of these tests to the prescriber during and after isotretinoin treatment
All pre-treatment pregnancy tests must be performed in a medical setting (e.g., office, laboratory). Prescribers will continue to be responsible for interpreting and documenting all pregnancy test results in the iPLEDGE REMS system. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests.
iPLEDGE Update (January 14, 2022)
One month after the implementation date of the modified iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, FDA continues to communicate with the Isotretinoin Products Manufacturers Group (IPMG) about their progress to resolve user access issues. We share the frustration and disappointment of many iPLEDGE users about the duration of this interruption and the impact these issues are having on access to treatment for many patients.
As a result of the transition to a new platform - which became necessary because the previous “switch” system administrator decided to discontinue support of the iPLEDGE REMS - all user data had to be transferred to a new REMS administrator’s database. Since the launch of the new platform, we have learned that there were problems merging user data from the previous system into the new system. As a result, many users have reported an inability to gain entry into their accounts in the new system without assistance from the iPLEDGE call center, causing higher-than-expected call volume and long wait times.
A team of experts at FDA have been in constant communication with the IPMG for the past several weeks. We have proposed two temporary solutions to help resolve these issues, but the IPMG has indicated that it is not feasible to quickly implement these options. Instead, the IPMG recently created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal. Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account. Users should check their email, including spam folders, for messages from iPLEDGE.
The IPMG reports that the majority of iPLEDGE users now have access to their accounts. Although there has been progress, there is a significant amount of work still to be done. While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users. The IPMG has indicated they remain committed to prioritizing efforts to restore user account access.
FDA will continue to update iPLEDGE users and the public on the IPMG’s progress of implementing the iPLEDGE REMS modification.
iPLEDGE Update (December 23, 2021)
DA is aware that patients, prescribers, and pharmacies are experiencing difficulties with the implementation of the modified iPLEDGE program, including the inability of many participants to log in to the website or long call center wait times, resulting in disrupted access to treatment for many isotretinoin patients. We understand and share the frustration caused by these challenges, and are urging the isotretinoin manufacturers to develop and implement a workable solution as soon as possible.
Patients, prescribers, and pharmacists: if you do not have access to your account on the iPLEDGE website, you can contact the iPLEDGE call center at 1-866-495-0654 for assistance.
FDA has also issued a CDER Statement requesting proposals for solutions from the isotretinoin manufacturers, pharmacies, and dermatology organizations.
iPLEDGE Update (October 8, 2021)
FDA approved a modification to the iPLEDGE REMS effective December 13, 2021 with system changes for health care professionals and patients. Please note that prior to this modification, the iPLEDGE website and iPLEDGE REMS Contact Center phone service will undergo maintenance starting Friday, December 10 at 11:59 p.m. EST until Sunday, December 12 at 11:59 p.m. EST. During this time, iPLEDGE will be completely unavailable.
Important changes for Health Care Providers:
Patient risk categories in the iPLEDGE REMS will be reduced from three options to two. The new risk category options are: patients who can get pregnant and patients who cannot get pregnant. Health care providers must assign and confirm their currently enrolled patients’ risk category for each patient upon their first login into the iPLEDGE REMS Website on or after December 13, 2021. The iPLEDGE REMS Prescriber Guide describes the qualification criteria for determining the reproductive potential of a patient.
Prescribers and their designees should ensure that any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires on December 11-12, 2021 is instructed to obtain their prescription before 11:59 p.m. (Eastern) on December 10, 2021.
Important changes for Pharmacies:
The REMS administrator has changed and the current “switch” pharmacy management system is being removed as a method to verify authorization to dispense isotretinoin. With the changes to the pharmacy management system, pharmacists will no longer use the switch system to obtain a pre-dispense authorization, known as a risk management authorization (RMA). Starting on December 13, 2021, all pharmacists need to obtain an RMA prior to dispensing isotretinoin by accessing the iPLEDGE REMS website or the iPLEDGE REMS Contact Center.
Pharmacies will not be able to obtain an RMA number to dispense isotretinoin between December 11-12, 2021. Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE REMS will be available on December 13, 2021.
Important changes for Patients:
Starting on December 13, 2021, patients will be assigned to one of two risk categories: patients who can get pregnant and patients who cannot get pregnant. Patients will also have the option of presenting a unique QR code at the pharmacy on their smartphone instead of providing their iPLEDGE identification number. Patients can access their unique QR code by logging into their account on the iPLEDGE REMS Website.
Any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires during the weekend of December 11-12, 2021 must obtain their prescription before 11:59 p.m. (Eastern) on Friday, December 10, 2021. If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again.
For complete information on the new iPLEDGE REMS requirements and to learn more about the new QR code for patients, please visit the iPLEDGE REMS website or contact the iPLEDGE REMS Contact Center at 866-495-0654.
iPLEDGE Update (March 15, 2018)
Please be advised that the isotretinoin manufacturers have informed FDA that the iPLEDGE REMS Program website will undergo maintenance on March 17 and March 18, 2018. The isotretinoin manufacturers have informed FDA that, during this time, their website will be completely unavailable. The iPLEDGE Program Contact Center will be open during its normal hours of operation (9:00 AM to 12:00 AM midnight ET, Monday through Saturday) and will be able to answer general information questions. The iPLEDGE Program Contact Center is available toll-free by calling 1-866-495-0654.
- Prescribers will not be able to interact with the iPLEDGE Program,
- Patients will not be able to complete Patient Monthly Comprehension Questions, and
- Pharmacies will not be able to obtain a Risk Management Authorization (RMA) number.
Prescribers and their designees should ensure that any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires March 17 or March 18, 2018 is instructed to obtain their prescription before 11:59 p.m. (Eastern) on March 16, 2018.
The isotretinoin manufacturers anticipate that their system will be available again starting Monday, March 19, and FDA will update this posting accordingly.
Any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires during the weekend of March 17-18, 2018 must obtain their prescription before 11:59 p.m. (Eastern) on Friday March 16, 2018. If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again
iPLEDGE Update (10/22/2010)
Today, FDA approved iPledge as a Risk Evaluation and Mitigation Strategy (REMS) in accordance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). This approval does not substantively change the program for patients, prescribers, dispensers, and wholesalers for approved uses of isotretinoin. FDAAA required the conversion to REMS of those RiskMAPs approved before FDAAA was enacted that contained certain features such as those of the iPledge program requiring prescriber and pharmacist certification, and documentation of safe use conditions before the drug can be dispensed, including pregnancy testing and agreement to use contraception.
iPLEDGE Update (10/2007)
FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). FDA approved several changes to the program. See IPLEDGE Update