Please read the linked Google doc:
First paragraph copied here:
"Dear Policy for the People,
I am writing on behalf of a community of patients (some of whom co-signed a copy of this letter, though their names have been redacted from public view) who have suffered a very complicated regulatory process when trying to obtain an underserved ADHD medication, which is currently in shortage. Through our experience, we have uncovered multiple breakdowns in current regulatory mechanisms - revealing clues into why so many medications (including life saving ones) are unavailable for patients. I will give a summary of why this issue is important, a detailed chronology that provides evidence of the current regulatory breakdowns, a proposed policy draft (“§314.800 Priority Review for Alternative Synthesis Routes of Drugs in Shortage”) as a potential solution to at least one of the underlying causes of shortages of medications like Desoxyn, along with additional comments from the co-signers. We respectfully request that you read this letter and use it as evidence to consider regulatory changes that could be made to prevent medication shortages like the ones we have experienced with this medication that we depend upon to function. "