U.S. Sen. Ron Wyden wants answers from the two federal agencies about the nearly year-long national shortage of Adderall, prescribed to over 41 million Americans to treat attention deficit hyperactivity disorder (ADHD).

The Oregon Democrat wrote 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.

In largely matching letters, Wyden chastised the DEA and FDA for failing to work together to end the shortage that has left millions of Americans scrambling – often unsuccessfully – to fill prescriptions for themselves and their children.

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

Wyden said he was dissatisfied with the agency responses in the seven weeks since he and his staff met with Milgram, Califf and their staffs on April 18. The senator has said he wanted to find out how Congress could help end the shortage and encourage the agencies to respond together to the distress he was hearing from an ever-growing number of constituents.

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

Instead, Wyden wrote, agency responses have been separate and incomplete.

One FDA production document only made the system’s workings more “muddy and obscure.”

Wyden wrote the DEA was too focused on drug industry-level production data instead how much medicine was available at the retail level.

“I am concerned that despite the heightened national attention to these medication shortages, the quotas and agency actions appear to focus solely on manufacturer production at the national level without appropriate attention to prescriptions that cannot be filled at the pharmacy counter,” Wyden wrote.

Wyden said the FDA information led him to question whether the agency had a clear picture of the supply and demand gap.

“I would like to know whether some of the obscurity may be due to the agency’s lack of information on the drugs that manufacturers send to distributors and distributors send to retail chains and independent pharmacies.”

Put together, the responses from Milgram and Califf weren’t going to improve the situation.

“It falls short of the statement and actions needed,” Wyden wrote.

Under federal law, the two agencies in two different departments control the supply and demand of Adderall and many other drugs.

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. 

Prescriptions grow, supply doesn’t

News reports surfaced in summer 2023 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 DEA has remained largely silent, declining any extended response to media requests. U.S. Rep. Abigail Spanberger, D-Va, said in March that when she asked the DEA to explain its role in the shortage, she received no reply.

Increasingly, the shortage has been linked to the FDA allowing 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. 

Despite the reports of more patients being prescribed Adderall, the DEA at the end of 2023 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.

Califf — the head of FDA — told the website WebMD in an interview this week that the telemedicine prescribing his agency approved had led to too many people chasing too little Adderall and other ADHD drugs. 

“If only the people that needed these drugs got them, there probably wouldn’t be a [stimulant medication] shortage,” Califf told WebMD. “There’s a large amount of use which is on the margins. And this is why we need better clinical standards.”

With the end of federal COVID-19 emergency measures in May, the DEA planned to require an in-person physician visits to continue receive a valid Adderall prescription.

But after receiving 38,000 comments on the plan, Milgram announced that the telemedicine rules would remain in place until November. But DEA did not announce changes to the supply going to pharmacies.

Dr. Ximena Levander, assistant professor of addiction medicine at Oregon Health and Science University, told the New York Times in March that there is another reason more people are getting Adderall and other medicines – telemedicine prescriptions were reaching patients whose medical conditions would otherwise go untreated. Rural areas might have no physicians nearby, or those that were listed had long wait times to see new patients – if they were taking new patients at all.

Levander said some of her own patients lived six hours away from her by car. Telemedicine allowed for treatment.

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

Short supply may be here for long haul

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.

“I am very concerned that many folks suffering with ADHD will not get the health care they need, which impacts their daily life, and in the worst case may lead them to use potentially lethal non-prescribed drugs,” Wyden said in his letter to DEA.

Given the lack of response he wrote he received from their April meeting, Wyden told the DEA and FDA heads that he wanted them to issue a joint statement to clearly articulate how they would work together to end the Adderall shortage. He wants a detailed explanation of the conflicting reports from agencies, manufacturers and pharmacies.

Each letter included a list of questions for the two agencies.

Oregon Capital Bureau has requested a copy of the two agencies response to the letter and the answers to the specific questions raised by Sen. Wyden.

Wyden questions to DEA:

1. Please provide a timeline on DEA rulemaking to provide transparency into allocation of aggregate production quota of controlled substances/chemicals used in controlled prescription drugs and individual domestic manufacturer quotas.

2. How does the DEA consider the limited availability of alternative medications in the evaluation of quota increase applications, such as an application for methylphenidate (branded as Ritalin or Concerta) given the shortage of amphetamine mixed salts?

3. What information does DEA have on the distribution/retail level on the transaction of controlled substances, if any, including canceled orders and sharp changes in price?

4. Congress required the DEA in the SUPPORT ACT to promulgate final regulations for a special registration for telemedicine under U.S. Code Title 21, Section 831(h), which the agency did not propose to do in its March 1st proposed rule or May 10th final rule. Will the DEA commit to the inclusion of final regulations for the special registration for telemedicine in the final rules on telemedicine flexibilities the agency plans to promulgate?

5. I would also like a recommendation from your office on how to improve the quota process so that regional and rural shortages for controlled prescription drugs gain the same attention as those in larger cities, and access to generic medications is prioritized when it comes to adjustments to the quotas.

Wyden questions for FDA:

1. A drug shortage on the FDA Drug Shortage List is accompanied by one of seven reasons listed in the Food and Drug Administration Safety and Innovation Act of 2012, which include “Demand increase for the drug” and “Shortage of an active ingredient.” Does the agency have the authority to disclose when a drug manufacturer refuses a request from the FDA to provide information on the cause(s) or extent of the shortage?

2. The FDA and the American Society of Health-System Pharmacists (ASHP) have two drug shortage websites with the latter often listing more shortages and regularly sourcing from a wider range of sources including patients and health care providers. Understanding that the two organizations share information, how does the FDA work to reconcile this situation when drug shortages appear on both lists and some drugs that are only present on ASHP’s list?

3. How does the agency, with the use of market data, factor in availability to more affordable generics and access to rural areas in its work to anticipate and mitigate shortages, particularly given potential limitations on information?

4. In May of 2022, HHS issued the Essential Medicines Supply Chain and Manufacturing Resilience Assessment, an action plan to address vulnerabilities in the pharmaceutical supply chain for medicines determined to be most critically needed for typical acute patient care that were drawn from the FDA’s Essential Medicines List. As the List was created to ensure protection against infectious disease outbreaks and various other emergent threats, does the agency have plans or a position on identifying medical products that do not fall into that category but whose shortage would present serious public health concern?

5. The FDA issued draft guidance in May of 2022 on risk management plans that certain manufacturers are required to develop, maintain, and implement beginning September 23, 2020. Congress enacted the requirement into law following a recommendation from the FDA-led Drug Shortages Task Force and in recognition of quality issues causing the majority of drug shortages. Please provide an update on the FDA’s finalization of the guidance and any plans for further rulemaking in this area.

6. The agency’s recent draft guidance lists the minimum information manufacturers must provide under section 506C of the FD&C Act and FDA regulations for “permanent discontinuance or interruption in the manufacture of a covered finished product that is likely to lead to a meaningful disruption in supply” but also recommends additional information the manufacturers provide updates to their initial notifications that would help the agency. Should Congress require manufacturers to provide any of the recommended additional information or give the FDA authority to require certain of the information be provided as relevant to the situation?