Telehealth startup Done said it "disagrees" with the criminal charges filed last week against its founder, Ruthia He, and David Brody, M.D., and plans to continue operating.
The company, in a statement posted to its website, said the fraud charges brought down by the Department of Justice are based on events that "principally occurred between February 2020 and January 2023."
"Both are presumed innocent," said the company, sometimes called either Done Global or Done Health, in its statement. "Done Global will continue to operate—and do everything in our power to ensure that the more than tens of thousands Americans that rely on us do not lose access to their mental health care. At the same time, we will continue to support our clinicians as they exercise independent clinical judgment, practice evidence-based medicine, and provide best-in-class health care."
Last week, the DOJ charged He, founder and CEO of Done Global, and Brody, the clinical president of Done Health, with fraud, accusing the executives of participating in a scheme to distribute Adderall online.
He was arrested June 13 in Los Angeles and Brody was arrested in San Rafael, California, the DOJ said in a press release. The two executives were charged with conspiring to commit healthcare fraud in connection with the submission of false and fraudulent claims for reimbursement for Adderall and other stimulants, the DOJ said.
According to the DOJ, He and Brody arranged the prescription of 40 million pills, including Adderall as well as other stimulants, generating more than $100 million in revenue.
In its online statement, the company said it is fully aligned with the Drug Enforcement Administration and the Department of Justice on eliminating drug abuse in America.
"Clinicians working through Done's platform have full medical independence on patient care. Done does not improperly influence clinicians on prescribing medications to patients," the company said.
The company also said it implemented "well-designed protocols to prevent potential abuse of medication."
"We are committed to operating a platform that sets the highest standard for psychiatric care and believe that our hybrid approach allows us to achieve the highest clinical quality and outcomes for our patients," Done said.
"We stand by the integrity of our services, and are proud to continue this important work," the company said.
The federal charges come amid an ongoing national shortage of ADHD medications. In May, the FDA reported that the shortage was beginning to ease. A total of nine manufacturers now have ADHD medications back in stock, according to the FDA’s drug shortage database, up from six last September, NBC News reported.
But, the arrests last week prompted the Centers for Disease Control and Prevention (CDC) to issue an official health advisory warning about a "potential disrupted access to care among individuals taking prescription stimulant medications and possible increased risks for injury and overdose."
Patients who rely on prescription stimulant medications to treat their ADHD and have been using this or other similar subscription-based telehealth platforms could experience a disruption to their treatment and disrupted access to care, the CDC wrote.
"A disruption involving this large telehealth company could impact as many as 30,000 to 50,000 patients ages 18 years and older across all 50 U.S. states." the CDC wrote in its health advisory.
Patients whose care or access to prescription stimulant medications is disrupted, and who seek medication outside of the regulated healthcare system, might significantly increase their risk of overdose due to the prevalence of counterfeit pills, according to the CDC.
Former Done employees are sounding the alarm, citing concerns about patient safety. Some former employees, speaking anonymously to Fierce Healthcare, said many clinicians have resigned yet the company continues its media spending to bring in new users despite having a much smaller care team.
Former employees also say the company's legal team appears to be based in China and is not responding to any inquiries from employees or providers.
The lack of transparency and proper communication from the company's leadership is unacceptable and poses a risk to consumer trust and safety.
Former Done employees generally cite a lack of transparency and proper communication from the company's leadership amid the current situation.
Done representatives have not responded to requests for comment.