FDA, DEA urge production push to replenish supplies of prescription stimulants
03 Aug 2023
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Source: FiercePharma
The heads of the FDA and the Drug Enforcement Administration penned a joint letter calling on manufacturers to increase production of prescription stimulants such as Adderall that have experienced shortages for almost a year.
The FDA and the Drug Enforcement Administration (DEA) are urging manufacturers to boost production of prescription stimulants as the shortage of drugs such as Adderall approaches the one-year mark.
In a joint letter signed by FDA Commissioner Robert Califf, M.D., and DEA Administrator Anne Milgram, the two officials said their agencies are working with manufacturers and other stakeholders in the supply chain to alleviate the current shortage and take steps to prevent future shortages.
“This is not a problem that the FDA and DEA can solve on our own (and) we have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount,” the letter said.
Among the causes of the shortage, the officials said, is the limit on amphetamine/stimulant production that the DEA establishes each year. Adderall is classified as a Schedule 2 drug by the DEA because of its potential to be abused.
Last year, production of amphetamine medications came in 30% below the full quota for the year, the officials said, representing about a 1 billion-dose shortfall of potential doses. Both agencies said they are seeing a “similar trend” developing this year as well.
“If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment,” the letter said.
Such a request by a manufacturer would allow the DEA to redirect the “allotment to manufacturers that will increase production.”
The two agencies also called on physicians, payers and other healthcare providers to closely monitor prescriptions for stimulants due to the “widespread misuse” and potential for addiction.
The dispensing of amphetamine products and other stimulants jumped by 45.5% in the U.S. from 2012 to 2021, according to Centers for Disease Control and Prevention data. The increase was particularly notable during the COVID-19 pandemic, when virtual prescribing was more widely allowed.
“We want to make sure those who need stimulant medications have access,” the letter said. “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.”
The Adderall shortage began to come to light late last summer when Teva, Amneal Pharmaceuticals, Purdue subsidiary Rhodes Pharmaceuticals and Sandoz—all major producers of generic and brand prescription stimulants—reported shortages.
Last August, Teva said problems “associated with packaging capacity constraints” at a single manufacturing plant would likely last through the fall. That timeline was later pushed into March 2023.
The manufacturing disruptions also coincided with a significant spike in Adderall prescriptions in 2022 that were attributed to a combination of increased diagnoses of attention-deficit/hyperactivity disorder and greater availability of the medicine through online startups.
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