麻豆传媒

In a , the heads of the Drug Enforcement Administration (DEA) and FDA acknowledged ongoing stimulant drug shortages and recounted their initiatives to improve access -- while calling for efforts to diminish potential overuse and misuse of these powerful medications.

"We want to make sure those who need stimulant medications have access. However, it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly," wrote FDA Commissioner Robert Califf, MD, and DEA Administrator Anne Milgram.

The ongoing shortage is the result of many factors, Califf and Milgram wrote. In the letter, they point to a manufacturing delay at one drugmaker; an that initially signaled the shortage specified that Teva was experiencing such issues.

This delay has since resolved, but its effects still reverberate, Califf and Milgram wrote. On top of that, regulators are dealing with "record-high prescription rates of stimulant medications."

They noted that stimulant prescribing rose 45.5% from 2012 to 2021, and was particularly increased during the pandemic, when virtual prescribing restrictions were eased.

Indeed, questionable prescribing of stimulants by digital mental health companies such as Cerebral and Done during the pandemic were the subject of several news reports, including (WSJ) citing a nurse practitioner who said she sometimes struggled to diagnose ADHD during 30-minute video calls.

About 6 months after the WSJ report, the of filling illegitimate prescriptions for stimulants to treat ADHD. Truepill was the preferred pharmacy provider for Cerebral, .

Nonetheless, patients with ADHD who need the medication are still struggling to access their drugs. It's not just amphetamine salts like Adderall in short supply; methylphenidate (Ritalin, Concerta) has also been intermittently available, .

That's why DEA and FDA have called on manufacturers to boost productivity. In the letter, Califf and Milgram stated that in 2022, amphetamine manufacturers didn't produce the full amount they were allowed to make (given their controlled substance status, stimulants have limits -- or quotas -- as to how much can be produced each year).

Companies only made about 70% of their allotted quota last year, "and there were approximately 1 billion more doses that they could have produced but did not make or ship," according to the letter. Data for 2023 show a similar trend, the officials stated.

Thus, the agencies called on manufacturers to "confirm they are working to increase production to meet their allotted quota amount," according to the letter. In addition, if any manufacturer doesn't want to increase production, the agencies asked them to give up their remaining 2023 quota allotment to be redistributed.

At the same time, FDA is asking professional groups and healthcare providers to boost their efforts to support the appropriate diagnosis and treatment of ADHD. This includes development of additional clinical guidelines for ADHD in adults, the letter stated.

The FDA said it has also taken steps to develop alternative treatment options for ADHD, including its 2020 authorization of a to improve attention in kids with the condition, and approval of viloxazine (Qelbree), a non-stimulant ADHD medication, in 2021.

In May, the agency also updated the boxed warnings on all stimulants to more clearly state the dangers of these drugs, including the risk for misuse, abuse, addiction, overdose, and death.

"We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed," Califf and Milgram wrote.

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