WSJ News Exclusive | DEA Pressed ADHD-Drug Makers About Impact of Telehealth Firms on Surging Demand

While the letter doesn’t cite specific companies, it reflects the DEA’s concerns about marketing efforts for ADHD treatment by telehealth companies such as Cerebral Inc. and Done Global Inc., whose prescribing practices the agency has been investigating. The DEA said in December that it wouldn’t allow any increase in 2023 production of pharmaceutical ingredients that go into Adderall and other stimulants used to treat ADHD. The letter, reviewed by The Wall Street Journal, was sent to drugmakers over the summer but hasn’t previously been reported.

The federal government regulates production of those ADHD-drug ingredients because of the potential for abuse. The combination of limits on production and a rise in prescriptions since the onset of the Covid-19 pandemic has contributed to what the U.S. Food and Drug Administration in October said is a shortage of Adderall, according to industry experts and a spokeswoman for

Teva Pharmaceutical Industries Ltd.

, the largest maker of Adderall.

“Teva is committed to patients who need access to the products their healthcare providers prescribe while also fully committed to carefully monitoring products controlled by” the DEA, the Teva spokeswoman said. She declined to comment on whether Teva had received the DEA letter.

The DEA letter said it was closely scrutinizing manufacturers’ production quota requests because of the “the sheer volume of ADHD medications on the market coupled with aggressive marketing practices and non-registrant marketing companies driving quota requests.”

Non-registrant marketing companies include Cerebral, Done and other telehealth providers that promoted ADHD treatment, said people familiar with the letter. It couldn’t be determined what other companies the category might include.

“DEA must ensure that any quota granted for the manufacturing of controlled substances used to treat ADHD is driven by a legitimate need and not improperly driven purely by profit motive, pressure from marketing firms, or a desire to obtain more market share—all factors that led to an oversupply of opioids during the prescription opioid crisis,” says the letter, which was signed by Kristi O’Malley, assistant administrator in the DEA’s Diversion Control Division.

The agency in December set next year’s quota at the same level as 2022 for ingredients used in production of Adderall and other ADHD drugs.

By comparison, prescriptions for Adderall in 2021 and through October 2022 increased by more than 10% a year, after growing by roughly 5% annually in the prior three years, according to data from research firm

IQVIA.

Adderall and the amphetamines used to make it are categorized as schedule II controlled substances by the DEA because of their high potential for abuse, the same category as opioids OxyContin and fentanyl. By law the DEA sets production quotas each year for the ingredients in schedule II drugs.

With the letter, the “DEA is asking: Do you know where your drug is going after you manufacture it?” said Karla Palmer, a lawyer at Hyman, Phelps & McNamara who specializes in DEA matters. “I think they’ve received a lot of blame for the opioid crisis, and DEA wants to get ahead of it this time.”

The DEA letter cites as part of the reason for its concerns unspecified media reports of telehealth companies aggressively marketing ADHD medications to patients.

The Journal has reported how Cerebral and Done have run ads that featured images of pills and promised clients a quick ADHD diagnosis. The reporting also showed how some clinicians at both companies felt pressured to prescribe stimulants and that Cerebral touted in internal presentations the higher profitability of clients who were prescribed stimulants.

Cerebral declined to comment. Done didn’t respond to requests for comment. The companies have said that they don’t pressure clinicians and that they provide an essential service.

The DEA has launched investigations into the prescribing practices of the two companies. Cerebral has said it hasn’t been accused of violating any laws and that it is fully cooperating with the investigation. Done has said it is committed to providing high-quality psychiatric care while complying with all applicable laws and regulations.

The DEA also said in December that it was seeking to determine whether to revoke mail-order pharmacy Truepill Inc.’s ability to handle controlled substances. The DEA alleged that the company had filled unlawful prescriptions for Adderall in the past. The announcement cited Cerebral, which sent Adderall prescriptions to Truepill.

Truepill said it was cooperating with the DEA and that it will be able to show there was no wrongdoing.

Truepill said in April that it would stop filling stimulant prescriptions. Cerebral said two weeks later that it would stop prescribing stimulants.

Write to Rolfe Winkler at [email protected]