A state investigator said Utah’s plan for malaria drugs may violate the law, but then her supervisor stepped in

FILE - This Monday, April 6, 2020 file photo shows an arrangement of hydroxychloroquine pills in Las Vegas.At least 13 states have obtained a total of more than 10 million doses of malaria drugs to treat COVID-19 patients despite warnings from doctors that more tests are needed before the medications that President Trump once fiercely promoted should be used to help people with the coronavirus. (AP Photo/John Locher,File)

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A Utah regulator alerted a Draper pharmacist that his plan to sell the state massive quantities of malaria drugs to treat COVID-19 patients likely violated the law. In a mid-April phone call, she urged him to abandon his plan.

By that time, Utah officials had already shelled out $800,000 in public funds to buy the drugs, apparently without confronting some of the legal concerns.

That Draper pharmacist — Meds in Motion’s Dan Richards — complained to powerful legislative leaders and higher-ups in Utah’s government about the call from a regulator with the Division of Occupational and Professional Licensing (DOPL). In reaction, the head of Utah’s Department of Commerce told him that the state was prepared to bend the rules to help him execute his plan, according to emails obtained by The Salt Lake Tribune through a public records request.

“We have handled COVID-19 matters with a pragmatic approach, realizing that statutes and rules haven’t quite been written with circumstances like this in mind,” wrote Chris Parker, interim Commerce executive director. “We have taken many measures in DOPL and throughout the Department of Commerce designed to work around technical requirements that, at least temporarily, need to yield to the broader effort of fighting and bouncing back from COVID-19.”

Parker added that the inspector who’d warned Richards about the potential legal violation was likely following up on a complaint and “did not understand the circumstances” or the pharmacist’s prior conversations with state health officials and regulators.

“It’s likely the work we had done simply hadn’t trickled all the way down to the front-line employee involved,” Parker continued in the April 15 message. “Rest assured, we will continue our pragmatic approach to meet whatever needs are presented by the current crisis in a way that doesn’t impose needless barriers.”

While he did try to assuage Richards’ fears, Parker followed up with top aides in Gov. Gary Herbert’s office, requesting clarity about the deal with Meds in Motion. State regulators had talked about the malaria drug purchasing plan with the health department, Richards and others, and Parker got the message that “this effort was well underway and we should let it proceed,” he wrote.

“I’m less concerned about the rigid strictures of that rule than I am with satisfying its purpose, which is to ensure the material is safe,” Parker wrote April 22. “Candidly, I wouldn’t mind a little cover, but I think assuring the safety of the supplies and facility is sufficient to do our job and also weather criticism for it.”

The problems that the DOPL investigator had flagged are not annoying issues of bureaucratic red tape, according to Ivins pharmacist Megan Milne.

“It’s not just that there are these laws ... and they’re just in the way,” said Milne, who submitted a complaint to DOPL this week over Richards’ activity. “They’re there to keep people safe and to make sure that those who are providing our drug supply can do so safely. The drug supply chain is very sacred, and if people can’t trust it, then it’s a huge problem.”

Richards’ drugstores appear to have the approvals necessary to compound, or prepare, medication on a patient-by-patient basis but not to make it for mass distribution.

Utah has no pharmacy federally licensed to compound drugs for hospitals or other pharmacies to use, according to the Food and Drug Administration.

The federal government made it harder to get such a license after a 2012 outbreak of fungal meningitis linked to injections prepared by a Massachusetts compounding pharmacy. More than 700 people fell ill after receiving the injections and 64 died, The New York Times reported.

Despite that, Utah officials spent weeks in talks with Richards about buying up to 200,000 packages of his medicine, chloroquine and hydroxychloroquine, for possible distribution to pharmacies across the state. From there, the plan was to make the malaria medicine available for free to anyone with a prescription certifying that he or she had an active coronavirus diagnosis.

Public health and infectious disease experts at multiple points along the way discouraged state leaders from buying the drugs — which could’ve cost the state up to $8 million — and noted there was no solid scientific evidence that the medicine was effective in fighting COVID-19. Last week, the Food and Drug Administration discouraged health providers from prescribing the medication outside a hospital or clinical trial because the drugs can trigger dangerous heart rhythm problems.

Herbert ultimately quashed the 200,000-dose deal with Meds in Motion and initiated a legal review of the earlier, smaller purchase, which he said happened without his knowledge. His office shared the results of the internal review this week, concluding that despite communication breakdowns, everyone involved in the first drug order had good intentions.

Meds in Motion refunded the state the $800,000 for the purchase and intends to donate the drugs to charities that “can use it immediately to address a worldwide shortage of anti-malarial medications in developing countries," according to a statement from the governor’s office.

As for the $8 million the Legislature budgeted for stockpiling medication, Senate President Stuart Adams, R-Layton, said it will remain in the state’s budget until officials need it.

“We could use it for any drug,” he said. “It’ll probably sit there until we find a use for it.”

While Herbert said he didn’t know about the state’s late March order of 20,000 medication packets from Meds in Motion, email records show that Kristen Cox, the head of the Governor’s Office of Management and Budget, signed off on the deal. About a week later, she disclosed the drug purchase to Jeff Burton, leader of the coronavirus response at the Utah Department of Health.

“We want to offer it to individuals when they learn they are positive,” Cox wrote in an April 5 email. “Of course, it is their choice and we have to provide ... any disclaimers around it.”

It wasn’t until about 10 days later that the DOPL concern about legal problems emerged.

Richards wrote to Adams, Senate Majority Leader Evan Vickers, Rep. Val Peterson and DOPL head Mark Steinagel about how a state investigator had warned him he was in violation of the law and would risk a citation if he persisted. He asked if SB3002 — legislation that granted temporary immunities to physicians and pharmacists dispensing off-label medications like hydroxychloroquine — would shield him from legal consequences.

“If not, what needs to change in order to be ensured that there is coverage? We have been working very closely with the state and have a very good plan. It would be a shame to have that plan foiled by a technicality,” Richards wrote. “We need to band together for the common good and get things turned back on.”

In response, Steinagel said he hadn’t been aware his agency was looking into Richards’ business and would try to find out more. Later that day, he responded again to say the DOPL investigator must have “missed the message” that the state was talking with Meds in Motion about distributing the malaria drugs.

“We will help the Legislature and the Governor achieve your objectives, with the help of the [Utah Department of Health] and the Coronavirus Task Force,” Steinagel wrote.

Parker, Steinagel’s supervisor, encouraged Richards not to be “unduly alarmed” by the DOPL investigator’s call.

“[W]e certainly wouldn’t make a citation decision lightly, especially in present circumstances,” he added.

In his email to Herbert aides, Parker explained that Richards was asking an independent lab to test the purity of his medication, although neither he nor officials in the health department had yet seen the results.

And he asked for guidance in addressing anticipated inquiries from others in the pharmacy industry and the public. The agency would be “a little uneasy telling our investigators to ignore a technical violation,” he wrote, adding that it would be helpful to put in writing the standards applied to Meds in Motion.

Vickers, R-Cedar City, said he joined in one March phone call with DOPL, health officials and Richards. Along with Carrie Dunford, member of the Utah Pharmacy Board, he told Richards that he might want to pause his drug compounding plans until he’d gotten the all-clear from the FDA. The state senator, a pharmacist by profession, said he wasn’t involved in conversations after that.

Weeks later, Parker wrote in his email that the FDA was “upset at Utah” over the malaria drugs issue.