The Drug Enforcement Administration (DEA) has alleged that telehealth and digital pharmacy company Truepill unlawfully dispensed thousands of prescriptions for stimulant medications such as Adderall used in the treatment of attention-deficit/hyperactivity disorder (ADHD).
The DEA announced last week that it served the startup with an order to show cause, which is an administrative action to determine whether a DEA certificate of registration should be revoked.
Representatives for Truepill did not respond to a request for comment.
Between September 2020 and September 2022, Truepill filled more than 72,000 controlled substance prescriptions, 60% of which were for stimulants including generic forms of Adderall, according to the DEA's investigation.
"In numerous instances, Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice," DEA officials said in a press release.
An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were unlawful by exceeding the 90-day supply limits and/or were written by prescribers who did not possess the proper state licensing, the DEA alleges.
Truepill filled prescriptions for several telehealth companies. It was reportedly online mental health company Cerebral's preferred pharmacy. That company is now being investigated by the Department of Justice (DOJ) for its prescribing practices as "possible violations" of the Controlled Substances Act.
According to media reports, the DEA was investigating Cerebral and digital therapeutics company Done Global Inc.’s practices for prescribing controlled substances.
Cerebral marketed ADHD treatments, including Adderall and its generic forms, directly to consumers using internet advertisements and social media. Cerebral arranged for patients to receive prescriptions for ADHD treatments through a telehealth visit and for Truepill to fill those prescriptions.
“DEA will relentlessly pursue companies and pharmacies that seek to profit from unlawfully dispensing powerful and addictive controlled substances at the expense of the safety and health of the American people,” said DEA Administrator Anne Milgram in a statement. “The men and women of the DEA remain committed to ensuring that every American can access essential medicines when they are lawfully prescribed and dispensed.”
In the wake of DOJ and Federal Trade Commission investigations into Cerebral reported on during the summer, a former federal prosecutor said the industry should expect U.S. regulators to ramp up their scrutiny of other telehealth companies.
"I think we're going to see a lot of activity in the space," Miranda Hooker, a partner in the health sciences department at law firm Troutman Pepper, told Fierce Healthcare. "I think we're going to see an increase in a lot of investigations and inquiries into services that are being provided via telehealth, including the prescription of controlled substances."
Launched in 2016, San Mateo, California-based Truepill offers a B2B application program interface that enables pharmacy fulfillment and delivery, white label packaging and product design. The company expanded its offerings beyond pharmacy fulfillment and delivery to include telehealth and an at-home lab testing network.
Truepill's investors include Oak HC/FT, Optum Ventures, Initialized Capital, TI Platform Management, Sound Ventures and YCombinator. The company has raised $255 million to date, according to Crunchbase. Truepill banked a $142 million series D round in October 2021, boosting its valuation to a reported $1.6 billion.
In April, Truepill said it was temporarily halting prescriptions for Adderall and other controlled substances used to treat ADHD.
"Truepill has an extremely high standard of clinical protocols and practices in place to ensure the safety of our patients. Out of an abundance of caution, Truepill is temporarily pausing all fulfillment of schedule 2 substances while we evaluate appropriate next steps," the company said in a statement to Fierce Healthcare at the time.
In June, the company let go 15% of its workforce—around 150 employees—across the country.
In August, there were reports about a third round of layoffs. The pharmacy startup said it was laying off about a third of its workforce. Sources told TechCrunch the company eliminated about 175 positions.