Teva's Adderall removed from FDA shortage list amid ongoing generic ADHD med shortage

In October 2022, the FDA first acknowledged a shortage of Adderall, a medication primarily used for attention-deficit/hyperactivity disorder (ADHD). Recently, there has been a positive development as Teva Pharmaceuticals appears to have stabilized its Adderall supply. According to the FDA’s shortage list, all Adderall products manufactured by Teva are available, except for the 5-mg generic version, which is expected to be restocked by June. Teva is manufacturing and distributing Adderall at levels consistent with historical norms but continues to face exceptional demand, as per the FDA's shortage database.

Several generic drug manufacturers, including Sandoz, Alvogen, Lannett, Sunrise Pharmaceutical, US Pharma Windlas, Epic Pharma, and Elite Laboratories, currently have their products in stock. However, three other generic manufacturers are experiencing shortages due to a lack of an active ingredient. Despite these improvements, many patients nationwide still struggle to fill their prescriptions, with pharmacies frequently facing back orders, according to NBC News.

In addition to Adderall, Vyvanse, another commonly prescribed ADHD medication, has been experiencing supply issues since June of last year. When Vyvanse’s patents expired in August, it was anticipated that the introduction of approved generics would mitigate the shortage. However, these generics have also encountered supply problems. Currently, Takeda, the brand name manufacturer of Vyvanse, remains the sole supplier, while ten approved generic manufacturers are listed as either out of stock or in limited supply due to shortages of active ingredients.

Both Adderall and Vyvanse are classified as controlled substances, leading to production limits imposed by the Drug Enforcement Administration (DEA) to prevent an oversupply that could potentially be diverted to the black market. In August, the DEA pledged to review and enhance the quota system that regulates the production of these active ingredients. In 2022, manufacturers utilized only 70% of their allotted quota, resulting in around a billion doses that could have been produced but weren't, as per a joint letter from the FDA and DEA.

The DEA and FDA have urged manufacturers to confirm their production increases and requested that companies no longer producing the medications relinquish their remaining quotas, allowing for redistribution. Despite these measures, the shortage remains largely unresolved, as stressed by the American Academy of Child and Adolescent Psychiatry, the American Academy of Pediatrics, and the Children’s Hospital Association in a recent open letter to the DEA and FDA. They argue that the current allocation rules are flawed and significantly underestimate the actual demand for these medications. The distribution to pharmacies is based on past demand, which does not account for the increasing number of ADHD diagnoses, indicating that the demand is unlikely to diminish soon.

In response to the broader drug shortage issue, the Senate Finance Committee has proposed new legislation. This proposal aims to enhance the resilience, reliability, and transparency of the supply chain by offering Medicare payment incentives to meet new standards. These standards include three-year minimum contracts with manufacturers and commitments to larger purchase volumes. The goal is to address and mitigate the persistent drug shortages affecting patients across the United States.