Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

Stakeholders expect the DEA to propose a special telemedicine registration system to keep tabs on telehealth providers prescribing controlled substances. The Drug Enforcement Administration’s long-awaited second attempt at a telemedicine prescribing rule has been handed off to the Office of Management and Budget (OMB) for review.   The rule is a major issue for telehealth companies that allow for the prescription of controlled substances, such as Adderall for ADHD, testosterone for transgender men, and buprenorphine for opioid use disorder. There is not yet a separate rule for buprenorphine prescribing like there was last March when the DEA attempted its first set of telehealth prescribing rules.  The pandemic-era flexibilities for telehealth prescribing will end in December 2024. The administration’s clock is ticking on the release of the rule for there to be enough time for the public to comment, the agency to review the comments, and promulgate a final rule before the end of the year. Organizations will likely also need a considerable amount of time to comply with the final rule.  DEA's last version of the telehealth Rx rule was proposed in March 2023. The agency received over 38,000 comments from the public, the overwhelming number of which said the proposal was too restrictive, as it required an in-person visit within 30 days of a controlled substance being prescribed via telehealth.  The DEA held two days' worth of public listening sessions in September 2023 to discuss a special telemedicine registration system for keeping tabs on providers prescribing controlled substances via telehealth. The special registration system has been required by law since the passage of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Still, the DEA has not followed through on the rulemaking to the consternation of stakeholders.  There have long been concerns about fraudulent online prescribing if the DEA makes permanent the relaxed, pandemic-era rules for telehealth prescribing of controlled substances. The DOJ yesterday arrested two digital health company executives for alleged fraudulent prescribing of Adderall and other stimulants. Once the Office of Management and Budget reviews the costs and benefits of the proposed rule, it will be published for public comment in the Federal Register. 

The FDA first declared an Adderall shortage in October 2022. In a welcome respite from the persistent nationwide Adderall shortage, Teva seems to have gotten a handle on its supply. The drugmaker has all of its Adderall products marked as available on the FDA’s shortage list, except for the 5-mg version of its generic offering, which is estimated to see supply recovery in June. The company is currently manufacturing and distributing the drugs “consistent with historic levels” but continues to see unprecedented demand, according to the FDA shortage database. Generic drug makers Sandoz, Alvogen, Lannett, Sunrise Pharmaceutical, US Pharma Windlas, Epic Pharma and Elite Laboratories also have their products in stock, while three other generic companies are still struggling with short supply due to “shortage of an active ingredient.” Even so, patients across the country often still struggle to get prescriptions filled with pharmacies often experiencing back orders, NBC News reports. Vyvanse, another popular attention-deficit/hyperactivity disorder (ADHD) drug, has faced its own supply issues since last June. Once the med’s patents expired in August, several approved generics were expected to help fill in the gaps but instead succumbed to shortages as well. Brand name Vyvanse maker Takeda is currently the only supplier of the drug, while copycats from 10 drugmakers with approved generics are all listed as either unavailable or in limited supply due to the active ingredient shortage. ADHD meds like Adderall and Vyvanse are unique in that both meds are classified as controlled substances. That means the Drug Enforcement Administration (DEA) sets production limits on the active ingredients to avoid an excess of supply that could spread to the black market. Last August, the DEA committed to “reviewing and improving” the quota process that determines how much ingredient manufacturers are allowed to produce. In 2022, that limit was not met, and drugmakers sold only 70% of their allotted quota for the year, making for some 1 billion extra doses that could have been made, the FDA and the DEA revealed in a joint letter (PDF). At the time, the agencies said they had called on manufacturers to confirm production increases and asked that those that opt to no longer produce the meds “relinquish” their remaining quota so the DEA can redistribute it. Still, the shortage largely remains “unmitigated,” the American Academy of Child and Adolescent Psychiatry, the American Academy of Pediatrics and the Children’s Hospital Association stressed in an open letter (PDF) to the DEA and the FDA earlier this month. The group notes that the rules in place to keep from excess products hitting the streets are flawed, as the allocation estimates “vastly underestimate” true patient need. As it stands, the amount of product distributed to pharmacies is determined by past demand. Along with a trend of rising ADHD diagnoses, the lack of supply suggests that demand won’t be slowing down anytime soon. More recently, the Senate Finance Committee introduced a proposal to address the broad drug shortage problem in the U.S. The legislation would offer Medicare payment incentives upon meeting new standards for supply chain “resiliency, reliability and transparency” including three-year minimum contracts with manufacturers and greater purchase volume commitments.