Transgenderism has eclipsed feminism. And it’s hurting women in countless ways. This is just one of them.
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 government being what it is, it won’t surprise you too much to learn that the whole thing has backfired. Badly.
Physicians and their teams have been unable to access the iPLEDGE site during an update to incorporate an FDA-approved modification to the iPLEDGE REMS that took effect December 13, 2021.
A scheduled change to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) has led to a delay in isotretinoin prescriptions. The iPLEDGE Program was implemented in early 2005 and approved as the iPLEDGE REMS in 2010 with the goal of preventing fetal exposure to isotretinoin. It also aims to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions.
The short version is that doctors can’t write a prescription without iPLEDGE which existed to prevent birth defects in pregnant women.
The transgender “fix” to eliminate women and replace them with pregnant people has crippled the system preventing doctors from writing prescriptions.
The American Academy of Dermatology (AAD) sent a letter to Patrizia Cavazzoni, the director of the Center for Drug Evaluation and Research at the FDA.
The Academy is aware of the issues faced by dermatologists and patients attempting to use the new iPLEDGE platform beginning yesterday; and leadership agrees that this is not acceptable for our patients or our practices. We have contacted the FDA and Syneos to urgently communicate that the new platform rollout has been a nightmare for dermatology practices and patients; and it has created an unacceptable disruption in patient care. In addition, we are reaching out to congressional committees overseeing the FDA asking them to take action and have contacted health policy reporters to shine a light on the crisis.
Over the last several weeks we have repeatedly warned the FDA and Syneos that the proposed changes did not reflect clinical practice and would impede patient care; and we asked for a halt to the program until our concerns could be addressed. We were told “no,” with the explanation that suspending the iPLEDGE program would not, from FDA’s perspective, provide the safeguards that are necessary to prevent embryofetal exposure. They also assured us that the iPLEDGE administrator was taking steps to address many of our concerns before launch. Clearly, those steps have not been effective.
Transgender inclusiveness wrecks womens’ lives yet again. Identity politics comes first and patient safety and welfare ranks last.