NCHR addresses proposed changes to acne medicine iPLEDGE program

March 29, 2023

I am Dr. Ealena Callender, an OB/GYN and Senior Fellow at The National Center for Health Research (NCHR).  Our think tank conducts, analyzes, and scrutinizes research on a range of health issues with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Thank you for the opportunity to express our views today on the proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements to minimize the burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin medications.

We appreciate the advisory committee making an effort to reduce administrative obstacles that may delay or interfere with treatment while preserving patient safety. While patient safety is critical, some current safeguards for patients who cannot become pregnant seem unnecessary. We strongly recommend changing requirements for patients who cannot become pregnant (PWCNBP). We suggest eliminating the requirement for prescribers to document repeat counseling for women who have had surgical removal of the uterus or surgical removal of both ovaries and women who are considered postmenopausal. These women will not regain the ability to become pregnant, so there is no medical reason to require repeated confirmation of counseling. As described in the FDA briefing documents, 72 to 78% of denials for PWCNBP are due to a prescriber not completing the counseling confirmation. This requirement has no discernable benefit, and elimination of this requirement would remove a significant barrier for these patients.

On the other hand, allowing abstinence alone in patients who can become pregnant raises questions, especially in the setting of widespread restrictions on reproductive rights in the U.S. Research indicates that many adolescents report being coerced into having sex.⁽¹⁾ Also, young adolescents are less likely to tell their healthcare provider that they are sexually active. One study of 169 adolescents found that about 25% of those between 14 and 17 years old were not truthful with their physicians about being sexually active.⁽²⁾ Abstinence is a very effective way to avoid pregnancy, and the iPLEDGE counseling seems effective. Still, we wonder how often adolescents – especially those 17 and younger – do not want their parents to know they have had sex, whether it is coerced or consensual. Therefore, they may withhold this information from their physician. We are not confident that most adolescents would disclose being sexually active to their providers, even though iPLEDGE requires patients to tell their doctor immediately if they decide not to be abstinent and then wait at least 30 days before engaging in sexual activity.

As we consider the costs and benefits of iPLEDGE, it is essential to note that researchers have found that iPLEDGE requirements can lead to financial losses for patients, with 55% of adult patients, 80% of caregivers, and 89% of children reporting missing school or work for medication-associated office visits.⁽³⁾ Female patients are especially likely to incur higher costs due to mandatory repeat office visits, testing and precise timing of prescriptions.⁽⁴⁾ If a requirement does not improve patient safety, why not eliminate it?

In summary, we want to be clear that we understand that this medication is a known teratogen and that it is critical to enforce certain restrictions to prevent fetal exposure. We recommend eliminating unnecessary barriers to equitable patient access when those barriers do not provide any benefits and considering whether to strengthen contraceptive requirements for adolescents for the reasons outlined above.

1. Black, M.C., Basile, K.C., Breiding, M.J., Smith, S.G., Walters, M.L., Merrick, M.T., Chen, J., & Stevens, M.R. (2011). The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention.
2. Liddon N, Pampati S, Steiner RJ, Hensel DJ, Tsung-Chieh Fu, Beckmeyer J, Herbenick D. Truth Be Told: Adolescents’ Disclosure of Sexual Activity to Healthcare Providers. J Adolesc Health. 2021 Mar;68(3):623-625. doi: 10.1016/j.jadohealth.2020.07.005. Epub 2020 Aug 15. PMID: 32807593; PMCID: PMC9119426.
3. Collins  M-K, Moreau  JF, Opel  D,  et al.  Compliance with pregnancy prevention measures during isotretinoin therapy.  J Am Acad Dermatol. 2014;70(1):55-59. doi:10.1016/j.jaad.2013.08.034
4. Shah N, Byrne M, Kirkorian AY. Exploring the costs associated with isotretinoin treatment. Pediatr Dermatol. 2021 Sep;38(5):1396-1399. doi: 10.1111/pde.14785. Epub 2021 Aug 31. PMID: 34463375; PMCID: PMC8578344.

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