drug shortages

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ADHD med shortages push DEA to up drug allotment by 23.5%

adderall, ADHD, controlled substances, DEA, drug shortages, fda, health, Science, Vyvanse / /

drug boost —

The DEA’s quota increase is for Vyvanse and its generic forms.

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ADHD med shortages push DEA to up drug allotment by 23.5%

While supplies of Adderall and its generic versions are finally recovering after a yearslong shortage, the Drug Enforcement Administration is now working to curb the short supply of another drug for attention-deficit/hyperactivity disorder: Vyvanse (lisdexamfetamine) and its generic versions.

This week, the DEA said it will increase the allowed production amount of lisdexamfetamine by roughly 23.5 percent, increasing the current 26,500 kg quota by 6,236 kg, for a new total of 32,736 kg. The DEA also allowed for a corresponding increase in d-amphetamine, which is needed for production of lisdexamfetamine.

“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA said.

Quotas

Just like Adderall (amphetamine/dextroamphetamine salts), Vyvanse (lisdexamfetamine) is an amphetamine-class stimulant classified by the DEA as a Schedule II drug. As such, the DEA controls its production levels to ensure demand is met while preventing excess supply that could find its way to the black market. The administration does this by setting an “aggregate production quota”—which is what the DEA adjusted for lisdexamfetamine this week—and doling out undisclosed allotments to drug manufacturers.

While various factors have contributed to the shortages of ADHD medications, some medical and industry groups have placed blame on the DEA’s quota system for underestimating demand and choking supply. For instance, the Adderall shortage began in 2022 following a labor shortage on the product’s production line at Teva, Adderall’s maker. But, while that production snag was resolved, prescription rates increased significantly, in part due to increased awareness of ADHD, broadening diagnosis criteria, and an increase in access with the rise of telehealth services, which boomed during the COVID-19 pandemic. In a report earlier this year, the American Society of Health-System Pharmacists pointed to the DEA’s quotas, saying they’re “exacerbating” shortages.

In an August 2023 joint letter, the DEA and the FDA responded to such criticism, suggesting that the quotas aren’t to blame. Rather, it’s that some manufacturers are not using up their allotment of controlled drugs.

“Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products [which include the two ADHD drugs], manufacturers only sold approximately 70 percent of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend,” the FDA and DEA wrote.

The FDA and DEA said they would work with manufacturers to ensure they would ramp up production of drugs in short supply or relinquish their remaining allotments.

Vyvanse shortage

A similarly complicated situation is seen with the current shortfall of Vyvanse and its generics. The DEA raised the quota after prodding from the Food and Drug Administration. In July, the FDA sent the DEA a letter requesting a quota increase. However, the shortage had actually begun in June 2023. At that time, Vyvanse’s maker, Takeda, said that a “manufacturing delay compounded by increased demand” had led to low inventory.

In August 2023, the FDA approved multiple generic versions of Vyvanse after Takeda’s patent exclusivity expired, raising hopes that the shortage would ease with the injection of new generics. But supply problems have persisted. In November, the Association for Accessible Medicines, which represents generic drugmakers, sent a letter to the DEA saying that generic manufacturers weren’t able to obtain enough raw material to “launch their products at full commercial scale,” because the quotas were standing in the way, according to reporting by Bloomberg.

FiercePharma reported another potential factor raised by lawmakers and industry watchers. Those onlookers took note of the timing of Takeda’s “manufacturing delays” just months before generics entered the market. With the significantly thinner profit margin of generic and off-patent drugs, there’s concern that manufacturers may de-prioritize production.

Last, the DEA flagged yet another factor in the supply chain: exports to foreign markets. While the FDA estimated a 6 percent increase in the domestic need for lisdexamfetamine between 2023 and 2024, the DEA’s export data showed a 34 percent increase in exports of lisdexamfetamine between 2022 and 2023, with expectations that exports would continue to increase this year and beyond. As such, the current 23.5 percent quota increase for lisdexamfetamine is only partly for domestic production. In fact, only a quarter of the 6,236 kg is intended for the US. Of the increased allotment, 1,558 kg is for domestic drug production, while the other 4,678 kg addresses increases in foreign demand, the DEA said.

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US drug shortages reach record high with 323 meds now in short supply

adderall, ASHP, cancer drugs, DEA, drug shortages, fda, generic drugs, health, pharmacists, pharmacy, Science / /

Terrible —

The shortages affect everything from generic cancer drugs to ADHD medication.

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Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

“All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz said in a statement Thursday. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients.”

Erin Fox, associate chief pharmacy officer of University of Utah Health, told CBS MoneyWatch, that most of the drugs in short supply are generic, older products, and around half are injectable drugs that require more stringent manufacturing processes.

There are myriad reasons for the hundreds of drug shortages now facing doctors and patients, many of which remain unclear. But, as Ars has reported before, the root cause of shortages of low-cost, off-patent generic drugs is well established. These drugs have razor-thin to non-existent profit margins, driven by middle managers who have, in recent years, pushed down wholesale prices to rock-bottom levels. In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. Several generic manufacturers have filed for bankruptcy recently.

For other drugs, the situation is more complicated. The ADHD drug Adderall, for instance, has been in critical shortage since October 2022, causing millions of patients around the country to struggle to fill their prescriptions. It began when a manufacturing delay for one manufacturer kicked off a shortfall. Although that problem has since been resolved, it came amid a significant increase in Adderall prescriptions, which spiked further during the pandemic when telehealth prescribing became more common. Additionally, because Adderall—made of amphetamine-mixed salts—is a controlled substance, the Drug Enforcement Administration sets limits or “quotas” on how much of it manufacturers can make. Such quotas can exacerbate shortages, ASHP said.

But, in a joint letter with the Food and Drug Administration last August, the DEA said that, by its data, manufacturers of amphetamine products (including Adderall) only sold approximately 70 percent of their allotted quotas in 2022. That meant that there were approximately 1 billion more doses that they could have produced but did not make or ship. At the time, the agencies said its 2023 data was trending in the same direction.

In 60 percent of cases, manufacturers do not know or do not provide reasons why their drugs fall into short supply, ASHP found.

The organization has put forth policy recommendations to prevent shortages and improve supply chains, advocating for federal and regulatory changes. “Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz said. “ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work.”

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