Original Story

The nationwide shortage of Adderall (amphetamine mixed salts) has triggered a domino effect. Patients are now struggling to fill prescriptions for other stimulant medications used to treat ADHD, including the generic equivalents of Vyvanse and Ritalin.

Some drug manufacturers blame the shortage on production quotas for stimulant medications, which are classified as Schedule II controlled substances, set by the Drug Enforcement Administration (DEA). The DEA disagrees and says that drug manufacturers aren’t producing their full quota of medication.

“For amphetamine medications, like Adderall, our data showed that in 2022, manufacturers did not produce the full amount that these limits permitted them to make — resulting in a shortfall of 1 billion doses that could have been produced but were not made or shipped — and the data for 2023 has shown a similar trend,” DEA Administrator Anne Milgram wrote in a letter on November 1.

The agency adjusted quota regulations in August 2023 to reduce the amount of a drug that manufacturers must keep in inventory, making it easier for them to voluntarily relinquish unused quota allotments. According to Milgram’s letter, 17 out of 18 manufacturers informed the DEA that they would use their allotted quota amounts by increasing stimulant medication production.

“Those manufacturers are currently in the process of providing us with information on how long it will take those stimulant medications to hit pharmacy shelves,” she wrote.

However, Bloomberg reported on November 17 that a letter addressed to the DEA from the Association for Accessible Medicines (AAM) said that generic drugmakers haven’t been able to obtain enough raw material to “launch their products at full commercial scale.”

In September 2023, spokespeople from five ADHD drug manufacturers told NBC News via email that their companies requested additional quotas from the DEA in order to fix this problem.

The U.S. Food and Drug Administration (FDA) first reported a shortage of Adderall in October 2022. More than a year later, millions of patients and caregivers still struggle to fill prescriptions, with no end in sight.

Cleveland.com reported that “about 94% of independent pharmacy owners and managers reported shortages of Adderall or generics in a September survey released by the National Community Pharmacists Association.”

According to a July 2023 ADDitude survey of 11,000 people, 38% of patients have experienced problems accessing ADHD medication since the shortage began. “The Adderall shortage is a slap in the face to those of us who suffer,” wrote one survey respondent. “We, who lack executive function skills, are forced to struggle with managing the acquisition of the one thing that helps us function. One thing I know for a fact is that those who do not have ADD are incapable of understanding what it is we go through. It is a travesty.”

On July 27, 2023, we revived DEA regulations to allow patients to transfer electronic prescriptions from one pharmacy to another without going back to their doctor.

Generic Vyvanse Fails to Relieve Stimulant Shortage

The arrival of generic Vyvanse (lisdexamfetamine dimesylate) promised to ease the stimulant shortfall. After Takeda Pharmaceuticals’ U.S. patent for Vyvanse expired on August 24, the FDA approved 15 manufacturers to produce generic Vyvanse capsules and chewable tablets to treat ADHD in patients six years or older, and moderate-to-severe binge-eating disorder (BED) in adults. 1Drugmakers began shipping generic versions of Vyvanse on August 31, according to Reuters.

Generic drugs provide the same clinical benefits and risks as their brand-name counterparts and are often available at significant cost savings for patients. The FDA stipulates that generic ADHD medications contain exactly the active ingredients as their name-brand counterparts; however, compounds in generic drugs are allowed to include different binding chemicals, fillers, and colors.

Since late August, GoodRx has reported that fill rates for generic Vyvanse account for almost 70% of prescriptions filled for ADHD medications with lisdexamfetamine as the active ingredient.

As of November 22, the drug shortage databases from the American Society of Health-System Pharmacists (ASHP)  has reported lisdexamfetamine dimesylate shortages among six drug manufacturers (Amneal, Hikma, Lannett, Mallinckrodt, Solco, and Sun Pharm). Three of these drug manufacturers attributed the shortage to an “issue with the active ingredient,” and Sun Pharma cited “DEA quota and active ingredient exhaustion.” Sun Pharma estimates that the product will be available in 2024. (Vyvanse chewable tablets are not affected by this shortage.)

Vyvanse was the most popular prescription stimulant, according to ADDitude’s July 2023 treatment survey. Nearly one-quarter of respondents said they (or their child) were taking Vyvanse to treat ADHD symptoms, outnumbering other prescription stimulants used by ADDitude readers, including Concerta (15%), Adderall (15%), Adderall XR (13%), and Ritalin (10%). It’s estimated that one million Americans were regularly taking Vyvanse, generating $2.5 billion in sales annually.

ASHP also listed a shortfall of methylphenidate extended-release and immediate-release tablets. Several manufacturers blamed the shortfall on “active ingredient delay” and “shortage due to DEA quota and active ingredient exhaustion.” Lannett estimated a late December 2023 to early January 2024 release date for methylphenidate 27mg and 36mg extended-release tablets. XLCare reported no estimated release date for methylphenidate extended-release tablets because “the company is awaiting DEA allocation for the active ingredient.”

DEA Responds to Stimulant Shortage

Milgram’s recent letter outlined several steps the DEA is taking to alleviate the stimulant shortage and  “increase manufacturer transparency,” including:

• Requiring drug manufacturers to submit their anticipated production timelines for medication before receiving their DEA quota allotments;

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• Requiring drug manufacturers to apply for quota allotments on a quarterly (instead of yearly) basis so DEA can provide quota allotments to manufacturers that have demonstrated they are using them to actually make and sell medications for current use;

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• Requiring monthly, digital reporting from manufacturers and distributors on the quantity of drugs being produced and shipped; and

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• Specifying whether a manufacturer’s quota allotment is for domestic or export production to track how much of a drug is available to Americans.

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“These changes are designed to help us see shortages coming and adjust more quickly over the long run,” she wrote. “We are also taking steps to reduce the burden on patients.

“As we said in our prior letter, there are still important issues that will need to be addressed through longer-term coordination by DEA, FDA, drug manufacturers, and other stakeholders to resolve these issues in the long term. DEA is committed to ensuring that patients who need stimulant medications have access to them and to ensuring that these drugs are being prescribed thoughtfully and responsibly, and we will continue working with our partners inside and outside government to do so.”

In August 2023, the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) issued a joint letter urging key stakeholders, including manufacturers, distributors, pharmacies, and payors, to work together to resolve drug shortages as quickly as possible.

Source

1FDA Approves Multiple Generics of ADHD and BED Treatment. FDA. Published August 28, 2023. Accessed August 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment?utm_medium=email&utm_source=govdelivery