FDA simplifies rules governing use of popular acne medication isotretinoin

Miami Herald

02-04-2025

The iPLEDGE program is a risk management system mandated by the U.S. Food and Drug Administration to prevent fetal exposure to isotretinoin, a medication used for severe acne that doesn't respond to other treatments. Accutane was a popular brand name for isotretinoin that is no longer available in the U.S. Other brands of prescription isotretinoin are still used, including Claravis, Absorica, Amnesteem and Zenatane.
Due to isotretinoin's high risk of causing birth defects, strict protocols have been established to ensure that patients, especially those who can become pregnant, adhere to safety measures during treatment. However, some of the guidelines outlined in the iPLEDGE program were previously overly strict, confusing and non-inclusive. Finally, the FDA has modified the program's guidelines.
Recent modifications to the iPLEDGE program
In response to feedback from healthcare professionals and patients, the FDA has made significant changes to the iPLEDGE program to reduce administrative burdens and improve patient access:
▪ Elimination of the 19-day lockout period. Previously, if patients did not obtain their isotretinoin prescription within a seven-day window, they faced a 19-day waiting period before they could requalify for the medication. The recent changes have removed this lockout, allowing patients to resume treatment more promptly.
▪ Acceptance of at-home pregnancy tests. The FDA now permits the use of at-home and non-Clinical Laboratory Improvement Amendments (CLIA) pregnancy tests, reducing the need for in-office visits solely for testing purposes.
▪ Gender-neutral patient classifications. Recognizing the diverse patient population, the program has adopted gender-neutral categories, focusing on patients' reproductive potential rather than gender.
Implications for acne patients
These modifications should significantly improve the experience for patients taking isotretinoin by reducing treatment delays and thus leading to better treatment outcomes, reducing office visits for the sole purpose of testing and promoting inclusivity.
Thus, if you are currently taking isotretinoin or are considering taking this medication, know that these guidelines should make the process much smoother and more streamlined moving forward.
Bottom line
The iPLEDGE program plays an important role in preventing harmful birth defects that could arise from use if isotretinoin. However, previous guidelines created several barriers for both patients and their doctors when treating and managing severe acne. These new guidelines are more reasonable, while still working to optimize patient safety.
I'm still on sabbatical and no longer run Baumann Cosmetic Institute, so please follow @SkinTypeSolutions on social media, or visit LeslieBaumannMD.com if you have questions.