Leading drug makers and pharmaceutical companies are having little luck addressing nationwide shortages of stimulant-based ADHD medications like Adderall, Vyvanse and Ritalin. Unfortunately for patients, the shortage does not appear to be any closer to a resolution than when it started almost a year ago.
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The biggest manufacturer of Adderall will not be increasing production to address national shortages of ADHD medication, despite a call from the U.S. government for drug makers to do exactly that.
Teva Pharmaceuticals Chief Executive Officer Richard Francis told Bloomberg that they are operating at “full capacity” at the moment and blamed their decreased output in previous years to COVID-induced work shortages which they have only just barely recovered from. Should they wish to increase the amount of Adderall they produce, they would have to buy or build more factories as their current infrastructure cannot handle bigger output. The company has declined to comment on whether or not they plan to invest in such infrastructure.
The pharmaceutical giant valued at just under $11 billion manufactured about 565 million Adderall tablets in 2021 but that was not enough, even with all the other producers in the market, to supply an exponential growth in national demand for ADHD medication or to address what drug makers have alleged are shortages in the materials needed to synthesize such medications.
The Adderall shortage began in Fall of 2022, marked by an FDA notice acknowledging the shortages with an estimate that things would be resolved in a month or two. That is not the case, however, as issued a joint notice on August 1 acknowledging that the shortage had been “understandably frustrating” for patients and providers.
“The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker,” the joint notice said. “While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.”
The joint notice did not give any kind of an estimated date this issue is expected to be resolved by, but instead urged drug makers to increase production to meet their allotted limits for production of a controlled substance. In fact, by the estimate provided, drug manufacturer’s only sold 70% of their collective allotment for these particular types of medications, which by the government’s own estimate equated to about a billion doses that did not get produced or sold.
“We (DEA and the FDA) have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount,” the joint notice said. “If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment. 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.”
The American Society of Health-System Pharmacists also reported last week that 141 different doses or formulations of ADHD medications were in short supply. The shortage was originally isolated to Adderall but as buyers and patients alike sought alternatives, supply of competing drugs like Vyvanse and Ritalin quickly dwindled. The ASHSP also indicated there were no estimated times for the majority of the shortages to be resolved, other than a short list of select medications produced by Sandoz Pharmaceuticals which are estimated to be back in stock sometime around mid-October.
No matter the cause, the shortages don’t appear to be going away anytime soon, especially with Teva unable to produce more than they currently are. Patients everywhere have reported issues refilling their prescriptions. A friend of mine told me she often ends up getting charged extra (double or triple the usual amount) for out-of-network pharmacies and extra doctor visits because pharmacies either don’t have the medication in stock or refuse to fill prescriptions for controlled substances. This process often delays access to medication that, without getting too redundant, is very unpleasant to go without when you have to take it regularly.
“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,” the FDA/DEA joint notice said. “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.”