Monday, Sept. 25, 2023|
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Millions of children with ADHD are starting a new school year without regular access to their medications, known as prescription stimulants, which have been in shortage for almost a year. While there are reasonable concerns about the overuse of such drugs, the lack of supply poses a risk to those who legitimately need them — and misguided government regulations are making things worse.
ADHD is a common neurodevelopmental disorder that’s typically diagnosed in kids and lasts through adulthood. Use of prescription stimulants such as Adderall, which can mitigate ADHD symptoms, rose 46% from 2012 to 2021, partly driven by the pandemic-era surge of telehealth prescribing among adults. Strain on the supply of stimulants was exacerbated by a worker shortage last summer that forced a large Adderall supplier to halt production, increasing demand for alternatives. Now those stocks are running low, too. Shortages of prescription drugs of all kinds have become more common in recent years, most often due to quality problems that interrupt manufacturing. Prescription stimulants face additional hurdles that limit their availability because they’re potentially addictive. Since the 1970s, the Drug Enforcement Administration has set annual quotas on how much individual manufacturers can produce. It’s true that prescription stimulants are prone to abuse, and use of such drugs and other controlled substances should be monitored by regulators. But the current quota system is the wrong way to go about it.
For one, the DEA’s lengthy and labor-intensive evaluation process has failed to adapt as the number of registered manufacturers of prescription stimulants has increased, from dozens in the 1970s to hundreds today. The agency’s initial assessments are also heavily reliant on historical sales, rather than real-time demand. While drugmakers can petition to have their quota raised during the year, many say their requests aren’t addressed promptly or can be rejected without explanation.
The opacity of quota allocation compounds the problem. While the DEA sets an industry-wide quota for all stimulant manufacturers, it doesn’t release publicly how that figure gets divvied up, making it impossible for companies to respond to market forces. Drugmakers that are unable to fill their allotted quota — due to labor shortages or manufacturing problems, for instance — have little incentive to disclose such information, in part out of fear of getting lower allocations in the future. Competitors can’t pick up the slack, since they aren’t aware it exists. The result is the worst of both worlds: a combination of spare manufacturing capacity and high unmet patient demand.
The Adderall shortage highlights the system’s dysfunction. Last month, regulators announced that drugmakers had sold only 70% of their allotted quota of prescription stimulants last year and could have manufactured as many as 1 billion additional doses — though the industry disputes those figures. Regardless, many generic drugmakers, in particular, are operating on such thin margins that ramping up production would be unrealistic without more deliberate planning. Drugmakers that produce multiple medications often simply choose to focus on more profitable drugs over which they can exercise more control.
The DEA says it’s “committed to reviewing and improving our quota process.” More transparency and real-time data about drug shortages would certainly help.
But rather than double down on an inefficient system, regulators should consider phasing out the quota in favor of more sophisticated tools to monitor abuse of controlled substances. This includes electronic tracing of products — part of a drug supply chain law passed a full decade ago that still hasn’t been fully implemented — and ramping up state-level monitoring programs that hold providers and pharmacists accountable for overprescribing. Eliminating quotas won’t resolve the shortages of Adderall and other medications overnight. But smarter government policies can create more predictability and prevent potential abuse, while still meeting patients’ needs.
— The Editors, Bloomberg Opinion/TNS
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