Core Concepts
FDA advisory panels are considering easing Isotretinoin requirements to improve patient access and safety.
Abstract
The FDA advisory committees are discussing ways to ease the safety requirements associated with Isotretinoin, a medication used for severe acne. The meeting aims to address issues with the iPLEDGE Risk Evaluation and Mitigation Strategy (iPLEDGE REMS) that have caused delays and prescription denials. Key areas of concern include the 19-day lockout period, home testing for pregnancy, and documentation requirements for counseling patients. Recommendations will be made regarding potential modifications to the iPLEDGE REMS at the end of the 2-day meeting.
- Isotretinoin safety requirements under review by FDA advisory panels.
- Discussion on easing burdens for patients, pharmacies, and prescribers.
- Focus on improving the iPLEDGE REMS for Isotretinoin.
- Concerns about the 19-day lockout period, home testing, and documentation for counseling patients.
- Recommendations for modifications to be voted on at the end of the meeting.
Stats
"At least 12 pregnancies have been identified during the 19-day lockout from March 2017-September of 2022."
"One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results."
"While we cannot support eliminating or extending the confirmation interval to a year, the (iPLEDGE) sponsors are agreeable (to) a 120-day confirmation interval."
Quotes
"It's intended as an additional layer of screening to detect pregnancy."