FDA botches updates to prescription authorization system

Last month, dermatologists and pharmacists across the United States discovered they could no longer prescribe or dispense isotretinoin, an important dermatological drug, after the Food and Drug Administration botched system software updates. online drug reporting system known as iPledge.

The updates weren’t sufficiently tested before they were released, which left doctors using the system and waiting hours on the phone with the FDA to get prescription approvals.

The system requires prescribers and pharmacists to obtain authorization before any isotretinoin (commonly known by the brand name Accutane) is administered to patients.

Isotretinoin is best known for treating severe acne, but it is also an essential and non-substitutable treatment for a variety of other serious skin conditions such as ichthyosis, cutaneous T-cell lymphoma, neuroblastoma and several types skin cancer eruptions due to chemotherapy, among others. .

Although the drug is effective for its intended use, the iPledge system was designed to prevent the drug from being given to pregnant women due to the high risk of birth defects in unborn children. Obviously, having safety nets to avoid harm to unborn children is a laudable public health goal, but the system that had been in place for 15 years suddenly collapsed on December 13, after the FDA called it made several revisions.

Why hasn’t the FDA been quiet enough? To answer this question, you have to realize that the Biden administration is not filled with “follow the science” technocrats, but anti-science and ideological groups starting at the top.

For example, the FDA is part of the US Department of Health and Human Services, and transgender activist and HHS Assistant Secretary for Health Rachel L. Levine has made it her mission to erase the concept of men and women at HHS and replacing it with “giving birth to people” and other Orwellian propaganda.

After it was discovered that the iPledge system allowed physicians to simply designate patients as “male” or “female” to initiate pregnancy safety protocols, HHS sprang into action to force physicians to use the terms “patients who can become pregnant” and “patients who cannot become pregnant” instead. Doctors who simply want to treat their patients’ skin conditions are now forced to accept transgender ideology’s biased claim that men can get pregnant.

FDA and HHS officials also couldn’t resist the opportunity to put the website through another major — and seemingly unnecessary — overhaul without proper troubleshooting or thought leader input. prescription and pharmacy. These hassled updates broke the website so that phone calls have been needed since mid-December to create accounts to both prescribe and dispense isotretinoin.

So amid the busy holiday season, on top of telemedicine complexities due to a resurgence of COVID-19, FDA leaders, still without a commissioner, mandated all prescribers and pharmacists to log into the new system. iPledge and create a new account, but the website was so dysfunctional that most prescribers could not log in or access previous patient records and had to obtain authorization over the phone.

Wait times have typically been several hours, with one dermatologist reporting a total of six and a half hours on the phone to receive clearance. Other calls were put on hold for eight hours only to be disconnected inexplicably, forcing providers to call back dozens to around 100 times and wait in the phone queue all along. Communications to the FDA’s “emergency” phone number received canned responses stating that the inability to care for patients due to the website’s issues was not considered an emergency.

This disarray has distracted pharmacists and prescribers from the already modest time allotted to them by pharmacy chains and insurance companies for clinical tasks and discussions with patients about drug safety.

Industry watchers have called the FDA’s implementation of its “new gender-neutral approach” “failure, chaotic and a disaster,” leading to renewed frustration with the person most directly responsible for this debacle, Dr. Patrizia Cavazzoni, head of the FDA. Center for Drug Evaluation and Research.

Due to Cavazzoni’s mismanagement, prescribers now have to resort to a perpetually late phone system, resulting in massive delays, confusion, and the inability to care for patients. Over a two-day period, more than 1,000 emails and phone calls from members of the American Academy of Dermatology Association came to Cavazzoni’s office expressing their frustration, but to no avail.

Syneos Health, which was paid to review the FDA’s iPledge website, should also share the blame. Indeed, the malfunctioning website was reminiscent of what Americans went through when the Affordable Care Act website was launched under President Barack Obama and also failed.

The non-functional, FDA-mandated iPledge website update represents a completely preventable situation and an unacceptable disruption to patient care. Americans depend on the FDA to thoroughly test drugs for safety and effectiveness, to ensure doctors follow protocols that limit harm to mothers and their unborn children, and to help medical professionals doing their job, not trashing it.

But when ideology drives decision-making and science and patient care take a back seat, we shouldn’t be surprised when HHS activists can’t even put up a website, even though it costs taxpayers millions of dollars and threatens the health of patients.

The Daily Signal publishes a variety of perspectives. Nothing written here should be construed as representing the views of The Heritage Foundation.

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