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The U.S. is facing a mystery of missing Adderall—one for which nobody has an answer.

Oct. 12 marked one year since the U.S. Food and Drug Administration’s formal announcement that pharmaceutical companies were unable to produce enough Adderall, one of the common amphetamine-based medications for attention-deficit/hyperactivity disorder (ADHD). As a result, many of the 41 million ADHD patients nationwide who rely on the drug daily to stay focused and reduce impulsive behavior have faced refill delays and empty inventories at their pharmacies.

Eight drug manufacturers have reported shortages of Adderall, which also means other major ADHD medications are now in short supply after psychiatrists turned to other treatment options for patients. In a year with the highest rate of drug shortages reported since 2014, “this one really baffles me,” says Marta Wosińsk, a senior fellow and health care economist at the Brookings Institute. The scarcity of Adderall remains uniquely confusing, she says, not only because there is no plan to remedy it, but because the major players involved in making and regulating the drug have provided little explanation, choosing instead to point fingers at one another while the public is left to speculate.

Experts say the FDA bears some responsibility for the ongoing shortage, as its lax reporting standards for manufacturers are the primary reason why there are still only theories about the shortage’s cause, rather than answers. These potential causes, which include increased prescription rates and the U.S. Drug Enforcement Administration’s tight control of critical ingredients, are impossible to investigate because of how little information the parties are required to provide to the public and one another.

Increased ADHD diagnoses

For months, the primary culprit for the shortage was believed to be an ongoing increase in prescription rates and ADHD diagnoses, which spiked between 2020 and 2021. Adderall’s active ingredient is a controlled amphetamine salt, and its production requires communication between the FDA, drug companies, and the DEA, which sets an annual cap on the amount of highly-controlled amphetamines that manufacturers can use.

Recently, however, it’s become more and more clear that something else is also going on—and that nobody wants to be responsible for figuring out what it is. In a joint letter to the public released on Aug. 1, the FDA commissioner and the DEA administrator stated that although they plan to re-evaluate quotas, manufacturers only sold 70% of the prescription stimulants they were permitted to in 2022, with 2023 rates on track to match. The implication was that the shortage has nothing to do with the amount of drugs released by the DEA, but is instead a result of how private companies are handling them further down the line. Following this finger-pointing at manufacturers, the government implemented a stopgap measure last month when the FDA approved the first generic versions of the ADHD medication Vyvanse, in essence making an Adderall alternative cheaper and more accessible to the public.

Read More: What’s Driving the Demand for ADHD Drugs Like Adderall

That nearly a third of the DEA-allocated allowance of a highly profitable prescription drug appears to be missing is massively confusing, says Wosińsk. “A lot of people in the industry have told me that this number seems way too high, that this just doesn’t seem right,” she says, “but there’s no information.” Knowing which manufacturers are actually contributing to that discrepancy would be hugely helpful, she says, but the FDA hasn’t released that information.

Some of the shortage could even stem from concerns about potential overprescription. There’s growing suspicion among experts that the increasing prescription rates can’t possibly all represent legitimate cases of ADHD, given the known abuse of stimulants as a concentration tool and the ease of acquiring prescriptions from telehealth companies. Though no one is ready to make any real allegations, some of Wosińsk’s colleagues have theorized that the missing medication could be sitting quietly in the hands of wholesalers, distributors, and pharmacies who fear future blame if the widespread prevalence of stimulants is someday condemned as a public-health issue. Then again, she adds, the 30% could just as easily reflect data-tracking or reporting errors. All anyone really knows, says Wosińsk, is that the DEA is unlikely to release extra medication as long as a large portion of what it’s already allocating remains unaccounted for.

Frustrated lawmakers

Lawmakers aren’t satisfied with the statement from agency leadership, who they say should take on the responsibility of fixing the problem rather than merely shifting the blame. “I understand that with an increase in prescriptions, the supply chain wasn’t immediately ready to contend with that,” says Representative Abigail Spanberger, a Democrat from Virginia, “But a year later, it isn’t enough for the DEA to say, ‘You know, actually, manufacturers weren’t utilizing their allotted quotas.’” Spanberger has led colleagues in calling for the DEA to investigate and resolve the shortage multiple times since it began, most recently in an Oct. 12 letter responding to the joint statement from the agencies.

“People say, well with the pandemic, and telehealth, a lot more people got diagnosed, and there’s a little bit of blaming the patient in that, which I absolutely am a little bit resentful of,” she says. Spanberger believes that part of why the shortage has lasted so long is because of a widespread assumption that many diagnosed Americans don’t actually need ADHD medication. The DEA’s quota system is in place in large part to prevent the abuse of Adderall, a concern that Spanberger says should be more carefully balanced against the needs of actual ADHD patients who may be at risk without their medication, including via a growing online amphetamine black market.

Wosińsk feels a little differently, and sees the ongoing shortage as an opportunity for the medical community to rethink the prescription of stimulants for ADHD, particularly in adults, for whom the long-term effects of taking them isn’t well known. “There’s really a concern that we are at the beginning of another wave of controlled substance abuse,” Wosińsk says. Eventually, she’d like to see leaders “paying attention more to demand, and thinking hard about who really needs it and how much is appropriate use.”

But first, like Spanberger, she wants to know where the missing Adderall is.

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By: Haley Weiss
Title: One Year Later, Where’s All the Adderall?
Sourced From: time.com/6324717/one-year-later-wheres-all-the-adderall/
Published Date: Tue, 17 Oct 2023 18:17:52 +0000

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