“For more than a year, the U.S. has experienced a shortage of Adderall, the medication used to treat attention-deficit/hyperactivity disorder (ADHD). Now, while continuing to deny its own role in the shortage, the federal government is making the problem worse by threatening manufacturers that could help ameliorate the crisis.
In October 2022, the Food and Drug Administration (FDA) announced a shortage of amphetamine mixed salts, Adderall’s primary ingredient. The announcement noted that manufacturers were “experiencing ongoing intermittent manufacturing delays” and it anticipated that the shortage could last until March 2023.
As Reason has reported since the FDA’s first announcement, the Drug Enforcement Administration (DEA) imposes production caps on Schedule I and II narcotics. Each year, drug manufacturers apply for a piece of the overall quotas. Even after a spike in demand during the COVID-19 pandemic, the DEA did not lift the production quotas on the ingredients used to make Adderall or its equivalents.”
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“In April 2022, Ascent submitted its annual quota applications for 11 total drugs, but instead of a speedy approval, the company was subjected to a DEA audit.
Investigators pored over Ascent’s books and identified discrepancies that indicated sloppy record keeping. For its part, the company admitted to committing infractions, though the details seem needlessly petty: In one example, “orders struck from [DEA forms] must be crossed out with a line and the word cancel written next to them,” Walsh wrote. “Investigators found two instances in which Ascent employees had drawn the line but failed to write the word.”
The audit forced Ascent to shut down production at its facility on Long Island, near New York City; company officials told New York that this constituted 600 million annual doses that it is unable to produce. It began laying off workers after more than a year in regulatory limbo.
Ascent sued in September 2023, seeking an injunction “compelling DEA to respond, to Ascent’s applications for quotas.” The DEA quickly denied all of Ascent’s quota applications, saying that it “lacks confidence in the data provided by Ascent in its quota requests” but giving no specifics.”
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“It’s entirely possible that Ascent did keep shoddy records, and perhaps it did misplace doses of drugs like opioids or stimulants that are ripe for abuse (allegations that the company denies). But the DEA’s policy of artificially constraining the supply of those drugs continues to harm those patients who actually need them.”