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Ted Cruz, Nevada Governor Bicker Over Coronavirus-Related Drug Regulations: ‘Practicing Medicine w/o a License’

Aaron Keller and Jesse WeberMar 25th, 2020, 6:35 pm
 

Sen. Ted Cruz (R-Texas) rebuked Gov. Steve Sisolak (D-Nev.) over an emergency drug regulation aimed at anti-malaria medications named by the Trump Administration as possibly successful in treating the novel COVID-19 coronavirus. Sisolak shot back that Cruz apparently didn’t notice that Texas did something similar.

It started when Sisolak signed an emergency regulation adopted by his state’s Board of Pharmacy which limits, but does not totally ban, the “prescription and issuance” of chloroquine and hydroxychloroquine, the two drugs at issue. The purpose of the emergency regulation was to prevent hoarding and to ensure the medications remain available for “necessary medical purposes,” the governor said.  The regulation effectively bans the dispensing of the drugs to outpatients with COVID-19 diagnoses but does allow the drugs to be dispensed to inpatients “in an institutional setting.”  The emergency regulation is best summed up legally as preserving the use of the drugs for the most serious COVID-19 patients.  (Early reports which characterized the move was a “ban” appear to conflict with the clear language of the regulation.)

“At this point in time, there is no known cure for COVID-19 and we must not withhold these drugs from those who need them,” the governor said in a tweeted announcement. The chief medical officer of the Nevada Division of Public and Behavioral Health said the state needed to “deal with facts, not fiction” as to the drugs.

https://twitter.com/GovSisolak/status/1242584263620321280

President Donald Trump proclaimed last week of the drug:

It’s shown very encouraging — very, very encouraging early results.  And we’re going to be able to make that drug available almost immediately. And that’s where the FDA has been so great. They — they’ve gone through the approval process; it’s been approved. And they did it, they took it down from many, many months to immediate. So we’re going to be able to make that drug available by prescription or states.

Yet even in Washington, medical experts have expressed tempered expectations. On CNN, Dr. Anthony Fauci, the Director of the National Institute of Allergies and Infectious Diseases and a member of the White House Coronavirus Task Force, said that there is “anecdotal data that [the drugs] wor[k],” but there needs to be more testing. The administration’s COVID-19 response coordinator, Dr. Deborah Birx, cautioned that while some countries have had success with the new treatment, “that doesn’t mean that it will show promise in Americans. It showed promise in the test tubes.” A study of 30 patients in China indicated that hydroxychloroquine really had no effect on the treatment of coronavirus. Plus, while President Trump claimed the drugs “have been approved” by the FDA, they have not, at least to fight the novel coronavirus. Vice President Mike Pence indicated that the FDA is in the process of “approving off-label use” for hydroxychloroquine.

This was the Cruz missive that got the ball rolling:

Nevada Governor Sisolak tried to break much of this down for Cruz on Twitter and pointed out that Cruz’s own state adopted tougher regulations than Nevada just did:

On March 13, 2020, Governor Sisolak declared a state of emergency in response to the coronavirus crisis. Under Nevada law, the Governor has broad powers during a state of emergency, including the ability to “perform and exercise such other functions, powers and duties as are necessary to promote and secure the safety and protection of the civilian population.” The Governor has wide authority to direct the State’s response to an emergency, such as a viral outbreak, including having medical personnel who are not even licensed in Nevada come to his state to provide aid without the fear of violating the law. Restricting the prescription and potential uses of medication because their safety and effect hasn’t been validated, and even doubted in the medical community, would seem to make Sisolak’s decision not only legal, but perhaps, correct.

The Board of Pharmacy, where this issue started, has the authority to”[a]dopt regulations governing the dispensing of poisons, drugs, chemicals and medicines.”  Under Nevada’s Administrative Procedure Act, the Board of Pharmacy, like all state agencies, has the power to enact emergency rules.  The governor, rather than the commissioner or head of the agency, has to sign off on all Nevada emergency regulations.  Emergency regulations are of limited duration.

The emergency regulation may cause friction with Nevada’s 2015 “right to try” law. (President Trump signed the federal equivalent of the law in 2018.)  Nevada’s laws allow for terminally ill patients to have access to certain drugs if particular conditions are met. First, a person must be in “terminal condition,” which means he or she must have “an incurable and irreversible condition that, without the administration of life-sustaining treatment, will, in the opinion of the attending physician, result in death within 1 year.” Some COVID-19 patients arguably meet that definition.  The law allows such patients access to experimental drugs which do not have FDA approval, but the drugs must have “successfully completed Phase 1 of a clinical trial.” Chloroquine and hydroxychloroquine have been approved as legitimate treatments for other illnesses, but not COVID-19.  The “right to try” statute is short and contains little immediate guidance on whether the “clinical trial” must be directly related to the illness the drug is sought to treat or whether any such trial or approval is sufficient.

Not every state is clamping down on the drugs in question. Gov. Andrew Cuomo (D-N.Y.) announced that the FDA gave New York the green light to start testing hydroxycholorquine with zithromax as a way to treat those diagnosed with COVID-19.

[Image via Drew Angerer/Getty Images]

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