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Adderall Shortage 2023: FDA’s Decision of Generic Vyvanse Manufacturing
Published 2:13 pm Thursday, September 7, 2023
In late 2022, The US FDA (Food and Drug Administration) stated that there was a shortage of amphetamine-mixed salts. This news worried many, especially those on Adderall medication. The shortage impacted people with ADHD, patients, and pharmacies across the country. Consequently, locating supplements to improve focus became an arduous task.
After months of waiting, not many improvements were apparent. Shortages of amphetamine-mixed salts drugs are still ongoing, although several manufacturers have disclosed a plan to increase their inventory.
The Cause
Shortages of many kinds of drugs have happened in the past, and the leading cause usually came from the manufacturer. It’s common for manufacturers to experience delays while producing drugs. Therefore, inventory will get lower in number.
Although delays are common, the difference between Adderall and other shortages is the imbalance of demand and supply. Not only were there manufacturing delays, but there was a significant increase in demand, especially when the pandemic struck.
Many stimulant prescriptions came during the pandemic as people became more aware of seeking the proper mental health treatments. The demand came along with an increase in ADHD prescriptions, scraping the supply even more. The spiking request came at the most inopportune time and triggered the shortage.
The pandemic also led to healthcare providing more accessibility for patients. Now, everyone can reach out to find the medication online and have it delivered. This improvement is a positive change, yet due to the supply shortage, it’s even harder to cover all online and offline demands.
The Impacts
The impact of the Adderall shortage is significant, especially for students. There have been many outbursts in younger patients who couldn’t receive proper ADHD medications. These outbursts include many behavioral issues, such as turning physical, breaking things, and hurting others.
Due to the spike in online and offline demand, many pharmacies started running out of supply. The shortage went as far as patients having to look for Adderall in multiple pharmacies only to find them out of stock. Patients must drive for hours to find pharmacies with Adderall in store. Caregivers find themselves compelled to restrict patients’ intake, despite the inconvenience it may entail.
Lack of medications in younger ADHD patients might lead to their symptoms worsening. It’ll bring difficulty not only to patients but also to their caregivers. Without medications, it’ll be hard for patients to get tasks done and may experience heightened anxiety.
The same difficulty was felt by college students as well. The number of college students diagnosed with ADHD saw a notable increase. The Adderall shortage led to a rise in academic underperformance and probation. Without the Adderall accessibility, the students started contacting counseling services, which were overwhelmed by the number of requests.
Why It’s Hard to Overcome The Shortage?
When talking about shortages, most patients will advise healthcare to increase the supply so they can fulfill the demands. By balancing supply and demand, the shortage issues will be sorted, and everybody can live happily. However, increasing supply isn’t as easy as it sounds.
Manufacturers often produce multiple drugs in one place. When a pharmaceutical manufacturer decides to increase production on one type of medication, they must halt or reduce production on other drugs under their care. It might cover one drug shortage and start another shortage of different medicines.
Not to mention, Adderall is a heavily regulated drug. They’re labeled as one of the drugs that might lead users to abuse their consumption, and even develop severe dependence. Not only Adderall but Vyvanse is also listed as a controlled substance on the same level as fentanyl and oxycodone. This is the reason why they are regulated.
The Drug Enforcement Administration must control Adderall’s distributions to avoid over-manufacturing, which might lead to Adderall circulating out of control. Each manufacturer had applied to produce a specific portion of their total inventory. They can request to amp up the number, but DEA can deny the request if the manufacturer has reached its full inventory quota.
FDA’s Decision
Adderall shortage affects many, and the Food and Drug Administration is undoubtedly not staying still. They’ve announced an approval of generic Vyvanse production on August 27th, which is one of the most widely-used alternatives to Adderall. Vyvanse is frequently recommended to people suffering from not only ADHD but also binge eating disorders.
Vyvanse production has recently increased, resulting in a current price of around $369. However, the FDA’s announcement allows multiple companies to begin manufacturing the drug, and the generic options will likely have a significantly lower price.
It has been almost a year since the shortage started, but the decision appears just in time for the back-to-school period. One can reasonably assume that a rise in Adderall alternatives will soon emerge as a solution to the shortage. It might take time to fulfill the demand or make the supply accessible in every pharmacy, but there’s a constant improvement in solving the shortage.