Rhodes Pharmaceuticals LP

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.

At the beginning of September, several manufacturers detailed a shortage of generic Adderall, otherwise known as amphetamine mixed salts, for a variety of dosage amounts. Now it appears that the shortage has reached more manufacturers. According to the American Society of Health-System Pharmacists (AHSP), shortages for the generic have hit a total of seven manufacturers for both extended and immediate-release capsules. For the immediate release version of the drug, shortages have been reported by the ASHP from manufacturers including Rhodes, Sandoz and Teva, in several dosage amounts, though none of the companies have reported the reasons behind the shortages. ASHP stated that Teva’s 10, 20 and 30 mg tablets are on backorder and the company estimates a release date for the middle of October or early- to mid-November. AHSP reported that Sandoz cannot estimate when they will have 10 and 30 mg doses available and Rhodes has 10, 20 and 30 mg doses in limited supply. The 5 and 15 mg doses are also on backorder and there is no confirmation as to when the drug will be available. However, Solco does have doses available at current. Shortages of the extended release capsules have been reported by several manufacturers including Amneal Pharmaceuticals, Camber Pharmaceuticals, Par Pharmaceuticals, Rhodes, Sun Pharma and Teva, with none of the companies providing additional details on the reason. Amneal has 15mg doses available. Several dosage amount are also in stock from Lannett, Prasco, Rhodes and Sandoz. The ASHP report shows that Amneal will release more in the 5, 10, 20, 25 and 30 mg dosage amounts sometime this month, while Teva will release supplies as they become available. The rest cannot give a release date at this time, according to the report. Endpoints News reached out to all the companies involved. Camber and Amneal declined to comment on the matter and Endpoints did not receive comment from the other manufacturers. Generic Adderall shortages continue as several manufacturers stare down supply squeezes In early September, Teva, Amneal, Purdue subsidiary Rhodes Pharmaceuticals and Sandoz were the only ones looking at shortages, according to the ASHP. The current Adderall squeeze, according to a report from Bloomberg , may be caused in part by a rise in prescriptions. This is due to a combination of factors such as increased dosage amounts and wider availability through startup prescription services. Earlier this year the FDA also sent a warning to two unregistered pharmacies accused of illegally selling Adderall online to customers without a prescription.

In early August, Teva hit a bump in producing the popular ADHD drug Adderall, as the company faced a backorder of the drug in 20 mg and 30 mg tablets, however, the situation has spread to a few other makers of the drug. According to a report from the American Society of Health-System Pharmacists (AHSP), the shortage has continued for Teva and other manufacturers, as Amneal Pharmaceuticals, Purdue subsidiary Rhodes Pharmaceuticals and Sandoz all face shortages. The ASHP report states that the companies did not give a reason for the shortage, but the issues extend to a wide array of dosage forms. For Amneal, their shortage is primarily in the 5, 15 and 25 mg amounts of amphetamine and mixed salts capsules. Rhodes’s shortage extends to several amounts, including its 10, 15, 20, 25 and 30 mg capsules. Sandoz only faces a shortage in their 10 and 20 mg amounts. For Teva, the shortage extends beyond just their original amounts with their 5, 10, 15, 20, 25 and 30 mg capsules all being impacted. According to a report from Bloomberg, the four companies combine to sell just over half of all generic-based Adderall in the US, per data from Symphony Health. The Bloomberg report stated that prescriptions for Adderall have skyrocketed in the past year due to a combination of increased dosage amounts and wider availability through startup prescription services. In April , the FDA also sent a warning to two unregistered pharmacies accused of illegally selling Adderall online to customers without a prescription. However, for Teva’s case, a spokesperson for the company, in an email to Endpoints News identified the supply issue as a downstream effect of past labor shortages on the packaging line which has been resolved. “Teva has active supply of both branded Adderall and its generic version and continues to produce and refill the channel regularly. It is possible that some may encounter a backorder (intermittently) based on timing and demand, but these are only temporary,” the Teva spokesperson said in an email to Endpoints. Endpoints also reached out to the other companies facing shortages for comments and will update the story accordingly. As for the current supply, there are still generic doses available from Lannett, Shire and Prasco, with Sandoz and Amneal also having other doses available. For the supply to return to normal, the ASHP estimates that Amneal will release its 5 mg capsules in late September, with the 15 and 25 mg capsules already being released. Sandoz said it cannot estimate when its 15 mg dose will be available, but the 20 mg capsules will be ready to go sometime in September. Rhodes did not give any specifics to the ASHP, but its 10, 15, 25 and 30 mg capsules are on backorder and will release the doses as they become available. Rhodes’s 20 mg capsules are now available but in limited supply. Teva currently has all its doses on back order and plans to release those doses later this month.