ADHD medicine shortage is 1 billion doses | News

A year-long shortage of medicines to treat attention deficit hyperactivity disorder (ADHD) was mainly caused by drug manufacturers making 1 billion fewer doses than authorized, two federal agencies said Thursday.

The inability of patients to fill prescriptions for Adderall has frustrated and often sickened Americans with 41 million prescriptions for medicine that they are unable to fill at many pharmacies.

The shortages have spread to other amphetamine-based drugs used to treat ADHD and other medical issues.

The joint statement by the U.S. Food and Drug Administration and the Drug Enforcement Agency, dated Aug. 1, said the shortage had several factors, including production glitches and labor problems. But the main reason for the extended delay in solving the shortfall is that drug manufacturers didn’t use the quotas they were given.

“Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70 percent of their allotted quota,” the statement said.

That is the equivalent of about one billion doses. Since last summer, patients have complained of not being able to fill prescriptions for Adderall and other amphetamine-based medicines.

The shortages began showing up last summer and despite statements by the FDA that the problem would be solved by the end of 2022, or the spring of 2023, the shortfalls continued and complaints from patients, medical professionals and numerous media reports brought a barrage of attention to the actions by the two federal agencies.

The admission on Thursday of the size of the shortage came only after repeated criticism by U.S. Sen. Ron Wyden, D-Oregon, that the agencies were unresponsive to congressional questions and showed a lack of urgency and candor in telling the public the scope of the problem.

“I’m glad to see it out and the clarity it provides around the quota allotment issue. It’s clear that manufacturers have work to do in easing this crisis – they need to either produce more or let other manufacturers do it, and make sure the DEA and FDA have the information they need,” Wyden said.

In the short term, Wyden said the federal agencies must act to redistribute unused authorizations to companies that can make the drugs soon. 

 In a separate statement, the DEA said it was prepared to “expeditiously review and adjudicate individual applications under the current authorized quota levels for amphetamine, in accordance with DEA regulations.” It included a letter sent to manufacturers on May 18 about the shortages. The FDA also sent a separate letter to Wyden as well.

In the joint statement, the agencies said there were limits on what they could do.

“This is not a problem that the FDA and DEA can solve on our own,” the statement said. “We are urging all stakeholders to work together to resolve these shortages as quickly as possible. The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug. 

Wyden issued a letter to manufacturers of ADHD medicines demanding they respond by Aug. 10 to his office with answers to a series of questions:

1. Have you met or do you expect to meet your allotted quota amount to produce amphetamine products for 2023?
2. If you will not meet the quota amount, how much of the remainder do you expect to use?
3. Have you or will you commit to relinquishing quota you will not use to the DEA? If not, please explain the reasoning.
4. If you have or will meet the quota, do you have excess production capacity and have you requested permission from the DEA to increase your quota allotment? If you have excess production capacity, are there other obstacles to requesting a quota allotment increase or using that capacity?

Under federal law, two different agencies with often conflicting priorities control the supply and demand of Adderall and other restricted medicines.

The FDA — part of the U.S. Department of Health and Human Services — controls demand. It determines who qualifies for Adderall prescriptions, which has the generic name Amphetamine-Dextroamphetamine.

The DEA — part of the U.S. Department of Justice — controls supply. It classifies Adderall and determines how much can be made and sold each year.

Adderall is listed by the U.S. Department of Justice as a Schedule II drug, which have a “high risk of abuse,” but are effective treatments for specific medical conditions. 

Prescriptions for Adderall and other ADHD medicines — such as brand name drugs Concerta, Ritalin and Vyvanse — all require a new prescription every 30 days. 

The FDA warned of an Adderall shortage in October, but said it would be resolved by the end of the year. It wasn’t. Reports of shortages spread across the country and were the subject of numerous media reports. But the FDA limited its comments, while DEA was largely mute on the issue. 

Wyden said he increasingly heard from constituents at town hall meetings around Oregon that getting prescriptions for themselves or their children was becoming impossible. 

“ADHD can severely interfere with daily activities, including work and school,” Wyden said in April, “but stimulant medications like amphetamine mixed salts are commonly used treatments that are very effective and safe.”

Doctors and mental health advocates have said the result of the shortages has been deteriorating health of patients, impacting their ability to work, study, and take care of their families. For children, it has meant untreated conditions that lead to problems at home and school. Patients who must call or visit several pharmacies to try – and often fail – to fill prescriptions either stop taking the medicine, self-medicate with other drugs, or seek the drug through illegal means.

Wyden said his queries about ADHD medicines have led to complaints from other constituents about shortages of other medicines, including those required by cancer patients. Wyden has also questioned the role of pharmacy benefit managers – middlemen between drugmakers, insurance companies and pharmacies – that Wyden says slows getting medicines to patients and often drives up the costs. Pharmacy benefit managers say they are regulating prices for the benefit of consumers and insurance companies.

ADHD medicine shortage background

News reports surfaced in summer 2022 of patients telling doctors they could not get their Adderall prescriptions filled. The FDA in October confirmed a national shortage, which is said at the time was due to a production problem at one company that would likely be resolved by year end.

It wasn’t, and reports of shortages only grew into early 2023. Between December and today, the FDA has changed its explanation for the shortage and the projected timeline for the problem to ease.

The lack of responsiveness from the agencies extended to queries from members of Congress. U.S. Rep. Abigail Spanberger, D-Va., was the first to make public here questions about the shortage – releasing a letter in December 2022 asking the DEA and FDA asking for an explanation of the shortage of Adderall and other medicines.

“Shortages of essential drugs, especially ones that have been on the market for years, have been a persistent problem in our healthcare system for years,” Spanberger wrote. “Drug shortages pose significant challenges to the public health because they delay care for patients, frustrate providers who must prescribe alternatives that may be less effective or pose additional risks to the patients, and expose consumers to price gouging by unscrupulous manufacturers.”

The following February she went public with complaints that her requests to the agencies had been ignored or resulted in boilerplate information that didn’t explain the problem. 

“I am disappointed that I have not received a response,” Spanberger wrote in February. “Providers have begun switching patients to alternative medications for ADHD, though alternatives do not work as well as the originally prescribed medication for some patients. Especially concerning are reports that desperate patients have died after turning to counterfeit pills laced with fentanyl.”

Wyden said he began hearing about the ADHD medicine shortage in early 2023 during town hall meetings around the state. He set up a meeting on April 18 with FDA and DEA leaders and staff to ask for a joint plan by the agencies to solve the shortage.

“I anticipated robust and timely follow-up,” Wyden wrote in June. “That has not happened, and I am deeply disappointed on behalf of the Oregonians I represent.”

Instead, the DEA and FDA followed-up separately with incomplete information and often contradicted each other. At times the DEA would not respond at all.

Wyden released a letter he wrote on June 2 to Anne Milgram, administrator of the U.S. Drug Enforcement Administration, and Robert Califf, Commissioner of the U.S. Food and Drug Administration, telling them their responses following an April meeting with were unsatisfactory. Wyden said some of the DEA material was “muddy and obscure,” making the problem more difficult to understand.

The shortage has been linked to the two federal agencies working at cross purposes.

The FDA allowed telemedicine providers to prescribe Adderall because the COVID-19 pandemic made visits to doctors difficult if not impossible. IQVIA, a health research firm, estimated late last year that the number of Adderall prescriptions in the United States jumped from 35.5 million in 2019 to 41.2 million in 2021. 

The COVID-19 pandemic had a profound negative impact on the mental health of Americans. Adderall required an in-person visit with a doctor to get a prescription. During the height of the COVID-19 crisis, people were dealing with new and often multiple challenges to their ability to cope. But at the same time, the ability to visit a medical provider was undercut by closed facilities, physicians who would not take on new patients, and staffing shortages that plagued medical facilities as it did many other businesses and organizations during the pandemic.

To ease the problem, the FDA expanded the options for telehealth, including allowing Adderall and other medicines to be prescribed without seeing the patient in person. This was especially crucial in rural areas, where the number of providers was already dwindling before COVID-19 accelerated the trend.

But a prescription didn’t guarantee access to the medications. DEA had not increased corresponding production quotas and continued to enforce restrictions on distribution meant to limit the amount of the drugs that could be diverted to illegal sales.

At the end of 2022, the DEA reported it would keep availability of key ingredients and production quotas for the drug itself unchanged. The agency said manufacturer data didn’t justify any increases.

Adding to the confusion, Califf — the head of FDA — told the website WebMD in an interview earlier this year that he agreed with critics who said the problem was too many prescriptions going to too many patients who might not need the medicine.

“If only the people that needed these drugs got them, there probably wouldn’t be a [stimulant medication] shortage,” Califf told WebMD.

But doctors who work in rural and other underserved communities said the telehealth prescriptions were actually showing how many people who needed help were unable to get medicine before when a long trip to a doctor was necessary – if one could be found who was seeing new patients.

Dr. Ximena Levander, assistant professor of addiction medicine at Oregon Health and Science University, works with patients in areas of Oregon where there hospitals, doctors and pharmacies are sparse. Telemedicine was a lifeline, she told the New York Times in March.

“It’s been really beneficial for access,” Levander told the Times. “Where are these people supposed to go?” 

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