FDA announces Adderall supply has been hit by manufacturing issues
In the US Food and Drug Administration (FDA) announcement, the agency stated that Adderall or Adderall IR ((d-amphetamine and l-amphetamine salts) had been added to its drug shortage website.
The website states that various forms of Adderall are on backorder and recovery of supply is expected by the end of the year. The FDA provided additional information on the supply issues by explaining that Teva had been supplying “above typical forecast due to increase in market demand.”
“Other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet US market demand through those producers,” the Agency added.
The issues over supply of Adderall have been on-going with a number of prominent manufacturers for months.
Initially, in August, Teva Pharmaceutical had communicated that it had experienced issues manufacturing the product, which the company had stated was the result of a labor shortage on the product’s packaging line.
Despite that issue having since been rectified, the supply of the product has been delayed due to the knock-on impact of this period. Teva is the largest supplier of the treatment in the US.
Other manufacturers, such as Sandoz and Amneal Pharmaceuticals, among others, have experienced issues in trying to fill this shortfall in the product because of the limits that are placed on how much of the medication can be produced by a single manufacturer. Production capacity is limited due to Adderall being a schedule II controlled substance.
As mentioned by the FDA, one of the issues facing meeting the demand for the product is the increase in prescriptions for the drug.
According to Trilliant Health, the overall volumes of branded or generic Adderall prescriptions have increased between the years 2018 and 2021. The healthcare analytics company particularly noted that prescription numbers had risen most rapidly in the age group between 22 and 44 years of age.
During their analysis, the company stated, “Notably, there are more adults receiving prescription Adderall than there are with a formal ADHD diagnosis. This discrepancy likely speaks to the number of individuals using a direct-to-consumer, self-pay service in this clinical scenario.”
In April 2022, the FDA and the US Drug Enforcement Administration (DEA) released warning letters to companies selling Adderall online illegally. It was also reported in September that the DEA had begun investigating Done Global Inc. over its practices for prescribing controlled substances.
Done is a digital therapeutics company that connects patients with qualified clinicians to prescribe treatments for attention-deficit hyperactivity disorder (ADHD), including Adderall. A similar company, Cerebral, announced in May 2022 that it would pause the practice of prescribing controlled substances as a treatment for ADHD for new patients.