ADHD drug market faces back-to-school supply strain

It has been 10 months because the Food and Drug Administration first announced a nationwide shortage of Adderall — probably the most widely used medications for attention deficit hyperactivity disorder — and the provision strain could potentially worsen within the months ahead.

While some supply issues have improved, many Americans are still struggling to seek out and fill prescriptions for the drug and other medications for ADHD that they often depend on to remain focused and complete day by day tasks.

Drug-shortage experts told CNBC that it’s extremely difficult to forecast how for much longer the shortages will last due to lack of transparency within the pharmaceutical industry — and a few are concerned about market conditions as children, who’re commonly affected by ADHD, head back to highschool. 

“Unfortunately, we would see the shortage worsen. We’re heading into back-to-school time, so I’m nervous about it worsening as we go into that season,” Erin Fox, a pharmacist on the University of Utah and leading expert on U.S. drug shortages, told CNBC.

Adderall is one among greater than 300 drugs briefly supply within the U.S. as of June, in line with a listing from the American Society of Health-System Pharmacists, which represents pharmacists in quite a lot of health-care settings. That list also includes Adderall alternatives like methylphenidate, which is usually known under the brand names Ritalin or Concerta. 

Adderall and alternative ADHD medications other than other drugs are Schedule 2 controlled substances. 

Meaning the federal government regulates how those drugs are made, prescribed and disbursed because they have been deemed to have a high potential for abuse and will potentially result in severe psychological or physical dependence. The designation also signifies that patients have to get recent prescriptions for those drugs each one to a few months. 

Thousands and thousands of Americans within the U.S. use the drugs to assist them concentrate, control their impulses and manage their schoolwork, employment or relationships with others. ADHD will likely be diagnosed in childhood and sometimes lasts into maturity.

An estimated 6 million children have been diagnosed with ADHD, and 60% were being treated with medication as of 2016, in line with the Centers for Disease Control and Prevention. Meanwhile, around 8 million adults have been diagnosed with the condition, but only a couple of quarter of that number are getting treatment for it.

Some drugmakers have said they expect to resupply just a few ADHD products in August or September, in line with an FDA database on shortages. But Margraf said “we should be cautiously optimistic” because drugmakers don’t disclose exact numbers of how much stock they’ll have available by then. 

That reflects an even bigger issue with the continuing shortages. It’s nearly not possible to know when they’ll end — or what exactly could be done to resolve them — due to lack of transparency within the pharmaceutical industry. 

“Little or no factual information is on the market. I believe that is one among the most important issues,” says Ozlem Ergun, a mechanical- and industrial-engineering professor at Northeastern University and an authority in pharmaceutical supply chains. “While you haven’t got transparency or information sharing, how will you understand and resolve an issue that’s complex?” 

“This really, really hurts the users and the hospitals and the health-care system. They’ve just about no vision of what the long run looks like,” Ergun added.  

Teva Pharmaceuticals, Amneal Pharmaceuticals, Novartis’s planned spinoff Sandoz and Purdue Pharma subsidiary Rhodes Pharmaceuticals, which all manufacture drugs targeting ADHD, needn’t publicly share details about where they manufacture medications, how much of them they make, where ingredients are sourced and their overall production capacities. 

And the Drug Enforcement Administration — the federal agency that regulates controlled substances — shares little information concerning the production quotas it sets for every manufacturer of Adderall and other ADHD medications.

The DEA specifically limits the quantity of raw ingredients, comparable to amphetamine, a drugmaker can get to fabricate those drugs.

“We haven’t got the quota amount that every company is given. And we also haven’t got the quantity that every company is definitely producing and in the event that they’re meeting those quotas,” said Fox of the University of Utah. “There is no technique to understand which company possibly is not doing the job and which firms are, so we just do not know exactly what is going on on.” 

Nevertheless, the DEA and FDA pointed to a unique problem in a joint letter released earlier this month. 

The agencies said an internal evaluation found that drugmakers fell 30% in need of meeting the complete quota for amphetamine medications in 2022, leaving about 1 billion potential drug doses on the table. They added that there is a “similar trend” occurring this yr. 

The DEA and FDA said they called on manufacturers to verify they’re working to extend production to fulfill their allotted quotas.

“There’s obviously a variety of finger-pointing happening here between the agencies and manufacturers,” Fox said. 

The shortages of Adderall and generic versions of the drug kicked off last August, when major manufacturers reported that their medications were on back-order. 

Manufacturers are required to notify the FDA of a shortage, but not the reason for the interruption. Nevertheless, the FDA pointed to “ongoing intermittent manufacturing delays” at Teva when it first announced the Adderall shortage. 

Teva previously said the manufacturing slowdown was partly tied to a labor shortage, which was quickly resolved. Teva didn’t immediately reply to CNBC’s request for comment concerning the state of its Adderall manufacturing. 

A surge in demand for Adderall and other ADHD medications seems to have played a big role, too. 

U.S. prescriptions for Adderall rocketed to 41.4 million in 2021, a greater than 10% increase from 2020, in line with IQVIA, a health industry analytics firm. 

One possible factor sending demand up, in line with experts, was the increased use of telehealth services through the Covid public health emergency which will have allowed for more relaxed prescribing standards for ADHD medications.

The pandemic also created a perfect storm of distractions — comparable to the shift to distant work and a thrum of hysteria, stress and grief over the uncertainty of Covid — which will have exacerbated some ADHD patients’ symptoms or convinced more those who they’ve the condition, prompting them to hunt treatment. 

The increased demand for Adderall amid shortages of the drug likely resulted in a domino effect, too, with health-care providers and patients being driven to show to alternative medications, triggering shortages of those drugs as well.