Reason for Hope?
In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
From Meeting to Mandate
The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.
The Five Requested Changes
In the November 30 letter, the FDA requested the following from the IPMG:
- Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
- Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
- Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
- Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
- Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)
Perspective on the Requested Changes
Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.
As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”
Dr. Barbieri reported no relevant conflicts of interest.
A version of this article appeared on Medscape.com.