Advocating for you – iPLEDGE win for patients

AADA secures iPLEDGE win for patients

For years, we have been working closely with the FDA to make the iPLEDGE program less burdensome for patients. Specifically, your Academy advocated that the FDA reclassify patients who cannot become pregnant. The FDA listened to us.

iPLEDGE program sponsors are currently in the process of updating the program, so that patients will be classified as “patients who can become pregnant,” or “patients who cannot become pregnant.” The modification is expected to take effect later this year.

Additionally, we asked the FDA to reduce the number of times patients who cannot become pregnant are required to show proof. The agency informed the iPLEDGE sponsors that it is willing to review a proposal to reduce the attestation policy. We are working with the FDA and the iPLEDGE program sponsors to iron out the details, building on the momentum of our reclassification success.