Hundreds of pounds of antimalarial drugs arrived in Utah last year as part of a controversial COVID-19 treatment plan.
Meds in Motion CEO Dan Richards — who admits he illegally imported the hydroxychloroquine and chloroquine — is now trying to save them from being destroyed by the federal government.
The Draper-based pharmacist contends that the 1,210 pounds of drugs shouldn’t go to waste just because he broke the rules in bringing them to Utah — and argues that instead of scrapping them, he should be allowed to compound them and ship them across the world.
“There’s a need worldwide for malaria medication,” said Greg Skordas, an attorney representing the 37-year-old pharmacist. “It’s not easy to get for some Third World countries, and we have it.”
Federal prosecutors, however, have insisted that Richards dispose of the hydroxychloroquine, a process that Skordas estimated would cost his client at least $10,000 and possibly more. The expense of preparing and exporting the medicine would be about the same, the attorney expects, but Richards would at least see the life-saving drugs put to good use.
Yet, it’s not at all clear that Richards would be legally capable of executing his plan, especially since his pharmacies don’t appear to be licensed to prepare medicine on a large scale and he’s admitted to importing the substances illicitly from an unregistered manufacturer.
Jacob Corsi, a Salt Lake City-based consultant with more than 10 years of experience in pharmacy regulation and compliance, said those federal rules and regulations are in place to keep people safe — and they shouldn’t be disregarded to send the medication to developing nations.
“Whether it’s American lives or not, we should still stand behind the science,” said Corsi, who worked at Meds in Motion several years ago. “They should get the same high-quality medications.”
A pile of drugs
Richards spent more than $210,000 on these shipments of hydroxychloroquine and chloroquine, Skordas said, which the pharmacist obtained from a Chinese company in the early days of the COVID-19 pandemic, when President Donald Trump and others were promoting them as a potential coronavirus wonder drug.
Prominent state leaders, including Senate President Stuart Adams and health department leaders, began collaborating with Richards in March 2020 on a constantly shifting plan to stockpile or distribute the medication in Utah. The deals — an $800,000 purchase and another $8 million proposal — both later collapsed under public and medical opposition, as evidence grew against the use of the drugs to treat the coronavirus.
Months later, federal prosecutors charged Richards with illegally importing the 500 kilograms (1,100 pounds) of hydroxychloroquine and 50 kilograms (110 pounds) of chloroquine that he was trying to sell to the state. He pleaded guilty in January to mislabeling the chloroquine as an herbal supplement and buying it from a manufacturer not registered with the Food and Drug Administration.
Skordas says the hydroxychloroquine was not mislabeled, but it was also inappropriately imported from an unregistered manufacturer.
While Richards acknowledges the drugs entered the country improperly, he vouches for their quality, Skordas said, adding that the pharmacist had the drugs tested by Lehi-based Analytical Resource Laboratories.
The lab, which did not immediately respond to a request for comment, took samples from the top, middle and bottom of each barrel and determined that the raw medication met FDA quality standards, according to the attorney.
And while medical experts were skeptical about administering the drugs as an off-label coronavirus remedy, hydroxychloroquine isn’t controversial at all for malaria or rheumatoid arthritis patients, having won its FDA approvals as a treatment for those diseases back in 1955.
Skordas estimates that his client could convert his stockpile of medication into enough pills to treat 325,000 people, and Richards is willing to do that work at his own expense and donate the drugs to countries where malaria is prevalent.
Malaria, a mosquito-borne disease, killed an estimated 409,000 people in 2019, with about two-thirds of them under the age of 5, according to the World Health Organization. Most of these deaths happen in sub-Saharan Africa, a region that Skordas said could potentially receive some of his client’s drugs.
“However, the Federal Government will not allow it,” he wrote in an email, noting that Sunday is World Malaria Day. “The Feds are insisting that all of it be destroyed, and not be used to save a single life anywhere in the world.”
Utah’s U.S. Attorney’s Office declined to comment on the case involving Richards or why federal officials believe the medication should be destroyed rather than repurposed. At the time of the pharmacist’s sentencing early this month, a prosecutor said federal regulators had not verified the quality of the hydroxychloroquine and chloroquine that Richards bought.
When asked about the medication, an FDA spokesperson said the agency “does not comment on ongoing criminal investigations or compliance matters.”
A ‘red flag’
Skordas says he plans to contact the embassies of countries with the highest rates of malaria and see if they’d be interested in the medication.
However, hydroxychloroquine and chloroquine have waned as malaria treatments in many parts of the world, as resistant strains of the disease have emerged, according to Michal Fishman, a spokesperson with the nonprofit Malaria No More.
The drugs are no longer used in Africa, which accounts for more than 90% of the world’s malaria cases and deaths, he said. But chloroquine (typically not hydroxychloroquine) is still administered in Central America and certain Asian countries where the drug is still effective against the disease, Fishman said.
In addition, Richards’ new humanitarian proposition could hinge on whether he’s legally permitted to turn his trove of raw drug ingredients into pills ready for export. Last year, after his COVID-19 treatment plan collapsed, the legal counsel for former Gov. Gary Herbert wrote that officials would be “severing all ties” with Meds in Motion because of “misrepresentations ... about their authority to compound large quantities of hydroxychloroquine.”
Businesses that compound or produce medication in vast quantities must have special FDA licenses, pharmacy experts and state officials have noted. Meds in Motion does not appear to have such an approval, according to the federal agency’s online database.
Corsi said his understanding is that when exporting drugs internationally, regulations can differ based on the nation receiving them. But he’s still doubtful that federal officials would let Richards reclaim medication produced by a manufacturer not registered with the FDA, which is supposed to oversee these producers to make sure pharmaceuticals are safe for human consumption.
“That right there is like the biggest red flag to me,” he said.
A gamble
Richards gambled a total of at least $355,000 on the drugs, he reported through Skordas, between the costs of purchasing, importing and testing them and buying a machine to encapsulate them — but he would’ve reaped millions of dollars in profit if state leaders had followed through on the idea of amassing the medications.
Initially, a group of tech executives pitched the idea of a philanthropic effort to set up community testing sites where they’d also distribute hydroxychloroquine in “med packs.” That plan quickly morphed into multimillion-dollar contracts with the state for the TestUtah initiative, and discussions with Richards about a standing order that would enable patients to pick up hydroxychloroquine without a prescription.
Those plans, too, ended up imploding as infectious disease physicians from around the state voiced their disapproval of spending millions in public money on an experimental treatment. State auditors later said lack of signed authorization or even evidence of verbal approval prevented them from figuring out who originally approved the state’s abandoned no-bid $800,000 purchase from Richards’ pharmacy.
Richards says federal investigators seized the imported drugs in early June, with the criminal case against him surfacing in January. A federal judge this month sentenced him to three years’ probation, handed down a $10,000 fine and required him to pay the cost, up to $30,000, of destroying the unused medication.
He’s also faced other professional repercussions.
State regulators in January put his license on a probationary status because of the federal allegations against him and fined him $5,750. The Utah Division of Occupational and Professional Licensing could revoke or suspend the license if Richards violates any term of his probation over the next five years.
Two Meds in Motion pharmacies, one in Millcreek and the other in Salt Lake City, have surrendered their licenses as of Tuesday, state regulators reported last week.
Although U.S. prosecutors have said the investigation into the hydroxychloroquine deal is done, Skordas maintains that his client has taken the fall for the failed drug proposal when state leaders were also culpable. The state was eager to acquire the medication “by hook or by crook,” the attorney has said, and while state officials didn’t know about Richards’ illegal activities, “I don’t think anyone was surprised either.”