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FDA Updates Status of the iPLEDGE Access Problems

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14. The IPMG has “created a new tool within the system to help resolve account access…

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG “created a tool within the system that helps resolve account access issues for certain user groups without having to use 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,” the FDA statement said.

“Prescribers may also send login links their designees who are still having trouble accessing their iPLEDGE accounts.” The FDA recommends that users check their email for messages from iPLEDGE including spam folders. The iPLEDGE strategy was created to protect fetal exposure from isotretinoin. It is highly teratogenic.

Days after the new, gender-neutral approach for the isotretinoin danger mitigation program was launched Dec. 13,, the FDA convened an emergency meeting with representatives of the American Academy of Dermatology Association to discuss the problems with the rollout of this program. There was anger on Twitter from dermatologists about not being able access the program or get to the call center.

A statement from the FDA on December 23 was followed. It urged manufacturers to create solutions for the website, and to collaborate with the AADA/pharmacy organizations to find solutions to minimize interruptions in treatment during the transition.

The modified REMS, launched on Dec. 13, is desi

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