Changes to iPLEDGE
Moving the needle
By Victoria Houghton, Managing Editor, November 1, 2021
DermWorld breaks down the latest highlights of AADA advocacy activities at the federal and state legislative and regulatory level.
As many dermatologists are all too aware, iPLEDGE is a distribution program designed to prevent pregnancies in patients taking isotretinoin and to prevent pregnant people from taking isotretinoin, as there is an extremely high risk of birth defects if pregnancy occurs while a patient is taking the drug.
iPLEDGE compliance
Read more about iPLEDGE compliance.
Given the significant patient and physician burden of iPLEDGE requirements, the American Academy of Dermatology Association (AADA) has been working closely with the U.S. Food and Drug Administration (FDA) to make the iPLEDGE program less burdensome for patients who cannot become pregnant.
Specifically, the AADA has been advocating for:
Reduced attestation frequency for patients who are not able to become pregnant
Improved contraceptive options and counseling
Alternative/flexible options for follow-up evaluation of patients
Additionally, the Academy has recently been advocating for an improved iPLEDGE classification scheme that would institute a gender-neutral categorization model based on child-bearing potential rather than on gender identity.
What’s next?
The AADA’s second request is to reduce attestation frequency for patients who cannot become pregnant. The FDA informed the iPLEDGE sponsors that it is willing to review a proposal to reduce the attestation policy. The sponsors would like to meet with the AADA in early 2022 to discuss the proposal in further detail.
AAD/A position statement on isotretinoin
Read the AAD/A’s updated position statement on isotretinoin.
