DEA Shuts Down Drug Factory Even as Adderall Shortage Persists
The DEA is cracking down on manufacturers, hurting patients who genuinely need those drugs.
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.
Instead, the shortage has persisted for more than a year, with no sign of ceasing.
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.
Rather, the FDA and the DEA have blamed drug companies, saying in August that "for amphetamine medications, in 2022, manufacturers did not produce the full amount" they were allowed to under DEA quotas. But the country's three largest pharmaceutical distributors, along with drugmaker Johnson & Johnson, settled a $26 billion lawsuit in 2022 brought by state and local governments over the companies' alleged complicity in the opioid epidemic. As a result, distributors cracked down on potentially suspicious orders of controlled substances, including psychiatric drugs like Adderall.
Last week, James Walsh of New York magazine reported on the ongoing saga of drug manufacturer Ascent Pharmaceuticals. The company estimates that its products made up 20 percent of the market for generic ADHD medications, including generic versions of not only Adderall but Concerta, Vyvanse, and Ritalin.
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.
In October 2023, the DEA announced that it had carried out Operation Bottleneck, billed in a press release as "administrative actions against six DEA-registered companies which, together, failed to account for more than a million doses of opioids." Specifically, the agency charged that Ascent "failed to make records available for inspection in a timely manner and shipped controlled substances without producing required documentation," and that "on numerous occasions, the company did not accurately account for millions of dosages" of drugs including oxycodone, hydrocodone, and methylphenidate, which is used to make Concerta.
In November 2023, just days after the announcement of Operation Bottleneck, Ascent filed a lawsuit against the DEA, the Department of Justice, and U.S. Attorney General Merrick Garland, among others. The lawsuit seeks to end the shutdown imposed by the DEA. In contrast to the DEA's allegations, the lawsuit claims that "Ascent cooperated fully with the regulatory inspection, often producing thousands of documents within a few business days of requests."
The lawsuit also claims that since the onset of the stimulant shortage, FDA regulatory officers reached out to Ascent in September 2022 and July and August of 2023, each time "ask[ing] whether Ascent had any supply of the products available." Each time, "Ascent replied that it did not due to DEA's failure to issue a decision on its Quota Applications and requested that FDA inform DEA of the problem." Two U.S. senators even reached out to Ascent with the same request, and each time the company was "forced to reply that its hands were tied."
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.
