U.S. Food and Drug Administration (FDA),

Please make it an urgent priority to save the patients by suspending the iPLEDGE program immediately and end it eventually. That way patients can get the drug without having to go through unnecessary procedures.

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Thousands of patients have lost access to prescription drug isotretinoin across the United States since December 13, 2021 due to iPLEDGE new website technical failure, completely broken voice response system and no backup or recovery plans by the implementing entities. Besides patients, doctors and pharmacies also lost their access to the website. Because of the inter-dependencies among doctors and pharmacies, patients who got access still can't get the medication.

This is absolutely unacceptable as -

• Isotretinoin is not an over the counter drug, it is expensive to get the medication and see the doctor every month. If there is a gap in taking this medication, the patient has to start over again.
• It's a very lengthy process which takes many months to complete the course. There are many side effects and lifestyle changes patients have to go through while on isotretinoin.
• Not getting the medicine even though there is no supply shortage is causing a mental health crisis in the isotretinoin patients. People are stressed and overwhelmed with the situation not being resolved for over 14 days.
• There is a financial burden on patients if they have to start over again due to the gap in continuation of the medication.
•  Patients are crying for help.

We hope the U.S. Food and Drug Administration (FDA) treats the situation as a medical emergency for patients and takes actions quickly even though it's already late for thousands of current patients. It would at least save the future patients.

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How iPLEDGE program works: It's just a useless questionnaire that patients have to submit on the iPLEDGE website after doctor's approval followed by blood work & urine test, then prescription is sent to the pharmacy. But pharmacies cannot release the medication to the patient if the same exact questionnaire is not complete every single time. This does not make any sense given the importance of continuation of the drug and negative effects of time gap in medication. The entire procedure of getting the drugs is in place even without the iPLEDGE questionnaire.

iPLEDGE alternative solutions: There are many researches that show iPLEDGE does not have any significant impact and should not be continued. It's an unnecessary step towards getting the medication. An alternative solution to iPLEDGE website can be - the patients can fill out the paper questionnaire at the doctor's office and then the doctor sends the prescription to the pharmacy. It can be as simple as that.