FDA, DEA asks stimulant makers to boost production or pass on allotments to other manufacturers amid shortages
The US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) want makers of certain stimulant drugs who don’t meet their annual DEA-set production quota to either make more of the drugs or give their excess allotment to other manufacturers to fill the gap. The agencies say this would help ease ongoing shortages of certain stimulant drugs used to treat attention deficit and hyperactivity disorder (ADHD), binge eating and narcolepsy.FDA and DEA wrote a letter dated 1 August that lays out what the agencies are doing to address the ongoing shortage of stimulant drugs, including Adderall (amphetamine salts), that have been affected by shortages in recent years.
While the demand for the drugs has steadily been increasing over the past decade, the issue was exacerbated when Teva Pharmaceuticals announced it couldn’t produce as much Adderall as it had planned due to manufacturing problems. Though the issues have been resolved, the US continues to face a stimulant drug shortage and the federal government says it needs the help of different stakeholders to tackle it.
“The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug,” the agencies wrote in a public letter. “That said, we are working closely with numerous manufacturers, agencies, and others in the supply chain to understand, prevent, and reduce the impact of these shortages.”
They note that the demand for stimulants increased almost 50% between 2012 and 2021 due to several factors and again jumped when telehealth services during the COVID-19 pandemic made it easier for people to get prescriptions for the drugs.
As controlled substances, DEA limits how much stimulants companies can produce but note that manufacturers often come nowhere near producing the full quota they are allotted which is partially fueling the current drug shortage. The agencies said that based on DEA data, manufacturers only sold 70% of the drugs they were allotted in 2022 and could have sold another 1 billion doses if they had produced them. They are concerned that the trend is the same for 2023.
FDA and DEA say they have asked stimulant manufacturers to either increase production if they can or allow other manufacturers to take over their remaining annual quota.
“If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment,” said the agencies. “This would allow DEA to redistribute that allotment to manufacturers that will increase production. DEA is also committed to reviewing and improving our quota process.”
FDA says it is already working to help develop alternative treatments to the drug stimulants currently in short supply such as authorizing a game-based digital treatment for ADHD and approving non-stimulant drugs for the condition. It has also asked professional groups and healthcare providers to develop additional clinical guidelines to ensure accurate diagnosis of ADHD so patients who need the drugs are getting them.
“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,” said the agencies. “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,” they added.
Public letter
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