FDA to Make Isotretinoin Prescribing Gender Neutral

In a nod toward transgender inclusiveness, the FDA revised the iPLEDGE risk-modification program for isotretinoin by rewording the reproductive categories for patients.

Beginning December 13, patients prescribed isotretinoin for acne will choose between two reproductive categories for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS): Patients who can become pregnant and those who cannot. The program previously had three reproduction-related risk categories: females of reproductive potential, females not of reproductive potential, and males.

Prescribers must assign new and existing patients to one of the two reproductive categories prior to writing a prescription for isotretinoin.

The revision to the reproductive categories in iPLEDGE ended a 3-year transition that began in June 2018, when the FDA notified isotretinoin manufacturers of impending changes to the iPLEDGE REMS and labeling to make the language gender-neutral.

According to the FDA, “This change was based on stakeholder feedback that gender-specific language can be a barrier to access for patients who do not identify with the previous gender-specific patient categories in the iPLEDGE REMS Program.”

The revisions came about with the cooperation and support of the American Academy of Dermatology Association (AADA).

“For years, the AADA has worked closely with the FDA to make the iPLEDGE program less burdensome for patients, including those who cannot become pregnant,” AADA president Kenneth J. Tomecki, MD, said in a statement. “This important modification was a direct result of our advocacy efforts on behalf of dermatologists and their patients.”

“The AADA supports any efforts to streamline the iPLEDGE program while preserving patient safety,” he stated. “We applaud these important changes to the iPLEDGE program; they will strengthen the patient experience. We continue to work with the FDA to assure patients have access to safe and effective treatments.”

Implemented in 2005 as the iPLEDGE Program, the program transitioned into iPLEDGE REMS in 2010. The program evolved from recognition that isotretinoin can cause birth defects if taken during pregnancy. The goals of iPLEDGE REMS are to prevent fetal exposure to the drug and to inform patients, prescribers, and pharmacists about the risks and the conditions for safe use.

Because the revision goes into effect on a Monday, patients whose existing prescriptions for isotretinoin expire on December 11 or December 12 should get refills no later than 11:59 p.m. ET on Friday, December 10, according to an FAQ page on the FDA website.

Along with the change to the reproductive options, another revision will eliminate the existing pharmacist management system. Instead, pharmacists will be required to obtain risk management authorization (RFA) by accessing the iPLEDGE REMS website or by calling the program’s contact center (866-495-0654) prior to dispensing a prescription for isotretinoin. If a patient does not pick up a prescription before the RFA expires, the patient will have to start a new authorization process with the prescriber.

The iPLEDGE REMS website and the contact center will be unavailable during December 11-12.