By Allison Sit
The FDA is implementing changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists. The changes come after two years of advocacy by the American Academy of Dermatology Association (AADA) including 600 messages sent by American Academy of Dermatology (AAD) members to the FDA in 2023 that requested changes to the iPLEDGE REMS Program. The approved changes include removing the “19-day lockout” for patients if they do not obtain isotretinoin within the first 7-day prescription window, revising pregnancy registry and counseling requirements, and removing the requirement that pregnancy tests must be performed in an CLIA-certified laboratory.
“Because of the AAD’s relentless advocacy over two years, the FDA has finally agreed to require much-needed changes to the patient safety program known as iPLEDGE for isotretinoin treatment, reducing administrative burdens in dermatology care and helping patients get access to their treatments in an easier manner,” explained AAD President Terrance A. Cronin, Jr., MD, FAAD. “The FDA supported the AADA’s critical recommendations that include allowing for continued use of at home and non-CLIA pregnancy tests.”
The changes may take up to a year or more to be fully implemented.
The National Eczema Association (NEA) announced recipients of nearly $1 million in research grants. The projects conducted by 18 investigators will explore a variety of issues including the science behind itch and inflammation, the psychosocial burden of eczema and new pathways for potential therapies.
“We started the NEA grant program to fill a much-needed gap in research and, 20 years later, it’s so encouraging to see the breadth and scope of work represented by the 2023 awardees,” said Julie Block, CEO of NEA. “These are both new and longstanding investigators working across disciplines to identify opportunities for better eczema therapies, better care, better lives with eczema – and one day, we believe, a cure.”
View the full list of recipients.
Mario Lacouture, MD, is the new chief of dermatology at NYU Langone Hospital — Long Island. He will also receive an academic appointment as professor of medicine at NYU Grossman School of Medicine, and will serve as the medical director of the Symptom Management Program at the Perlmutter Cancer Center on Long Island.
“The opportunity to lead NYU Langone Dermatology on Long Island aligns with my commitment to high-quality, accessible care and my fondness for the people of the Island,” said Dr. Lacouture. “In addition, at the Perlmutter Cancer Center, I will build on our experience improving cancer patients’ quality of life by preventing and treating skin issues during treatment, so that now more people can access our compassionate, specialized care for side effects, with a focus on the whole patient.”
While at Northwestern University in Chicago, Dr. Lacouture created the first clinical and research program in oncodermatology, establishing a distinct subspecialty within dermatology and oncology that is dedicated to the science and care of skin, hair and nail conditions in cancer patients and survivors. Nearly 70% of National Comprehensive Cancer Centers have adopted this oncodermatology model.
