2023-08-01 14:30:32 ET
Amid an on-going shortage of the ADHD drug Adderall (mixed amphetamine salts), the US FDA and DEA are asking manufacturers to step up production.
The nationwide shortage has been happening since at least October 2022 when the FDA issued an advisory , specifically mentioning Teva Pharmacetical Industries ( NYSE: TEVA ). The same month, Novartis ( NYSE: NVS ) unit Sandoz reported supply issues with providing generic Adderrall.
According to an Aug. 1 letter from the heads of the FDA and DEA, the agencies "have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount."
Because Adderall is a controlled substance and has potential for abuse, there are limits to how much of the drug companies can produce. However, the letter states that in 2022, drugmakers sold 70% of their permitted quota, meaning that 1B additional doses could have been made.
The FDA and DEA noted that current trends indicate pharma companies won't reach quotas for 2023 either.
"If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment," the letter states . "This would allow DEA to redistribute that allotment to manufacturers that will increase production."
According to an FDA drug shortages database , "Teva ( TEVA ) is manufacturing and distributing consistent with historic levels. We continue to see unprecedented demand." Sandoz says that they have availability for all their dosage strengths. Other companies that aren't publicly traded are indicating a shortage of active ingredients.
For further details see:
Adderall shortage prompts FDA, DEA to ask for production boost