Adderall Shortage Has US Agencies Urging Drugmakers to Boost Output
Story by Ike Swetlitz • Yesterday 4:56 PM
(Bloomberg) — US drug regulators and law enforcement officials asked pharmaceutical companies to manufacture more Adderall, an ADHD medication that has been in short supply for nearly a year.
The Food and Drug Administration, which reviews drugs for safety and effectiveness, and the Drug Enforcement Administration, which polices controlled substances like stimulants, “have called on manufacturers to confirm they are working to increase production,” the agencies wrote in a letter Tuesday.
The drug has been difficult to find since last August, after a labor shortage at Teva Pharmaceutical Industries Ltd, the main manufacturer, constrained supply. That’s left millions of Americans with attention-deficit/hyperactivity disorder struggling to fill monthly prescriptions for a medication necessary for many daily activities. The drug is also used to treat narcolepsy.
Demand for the drug reached an all-time high in the third quarter of last year with 11.3 million prescriptions filled at US retail pharmacies, according to data from Symphony Health. Prescribing has been increasing steadily for the past decade as more people get diagnosed with ADHD and the condition, as well as medication treatment for it, becomes more socially acceptable.
Over the past year, as shortages rippled across the market, fewer people were able to fill prescriptions, the data show. Health care providers prescribed alternative ADHD drugs, which led to supply constraints for Vyvanse, made by Takeda Pharmaceutical Co, as well as shortages of methylphenidate drugs, a category that includes Novartis AG’s Ritalin and Johnson & Johnson’s Concerta.
Adderall, like many ADHD medicines, is a controlled substance, meaning it has the potential for addiction and abuse, and companies are only allowed to manufacture a certain amount each year. DEA sets these quotas and can modify them. Over the past year, companies have cited DEA quotas as an impediment; the DEA has disputed this, saying that companies have plenty of quota available.