The city placed Honolulu Mayor Kirk Caldwell’s plan to purchase $2 million worth of COVID-19 tests on hold after state Health Director Bruce Anderson wrote a letter criticizing the decision.
The letter said the tests Caldwell wanted to buy were unusable in the United States because they lack the proper emergency use authorization from the U.S. Food and Drug Administration.
The letter begged the question: can the state health department decide which tests can be used?
“The short answer is no,” Anderson said.
He explained that while the health department certifies all commercial laboratories, it does not regulate the procedures conducted in the labs, such as COVID-19 tests.
“We are involved [in] that we certify the laboratories generally, but the FDA is the key agency here to approve the use of a particular method,” Anderson said.
Because COVID-19 is such a new virus, the FDA has not fully approved any coronavirus tests, but it is certifying some by issuing emergency authorizations.
Beyond that, the FDA has further loosened standards. Even tests without the authorizations can be distributed if the developing lab applies for it, and validates its research. However, the labs cannot claim that the tests are FDA-approved.
Because the state health department lacks the authority to regulate the tests, it can only advise against using those that aren’t approved. It cannot stop doctors, or the city, from using the tests.
Three weeks ago, Caldwell asked his director of enterprise services, Guy Kaulukukui, to expand testing on Oahu and to help the community health centers that were struggling financially.
“Everybody else except for Waikiki [health center] thought it could only stay open through July, and Waikiki thought they could stay open through December. So that's the picture of their financial health,” Kaulukukui said.
“So what we came up with was a program that brought them together. Let's find a way to do more testing, let's ask the community health centers to do the testing for us and let's compensate for it.”
After Kaulukukui and Caldwell consulted with city officials in Los Angeles, Honolulu decided to purchase the same tests they were using. The tests were from Everlywell, a private medical testing company based in Nevada.
The $2 million the city planned to spend was intended before the COVID-pandemic for sand replenishment at Ala Moana Beach Park.
Caldwell thought the money could be better spent on acquiring more tests.
Kaulukukui said he and Caldwell spoke with state epidemiologist Sarah Park and she raised concerns about the tests.
While Everlywell itself does not have emergency use authorization from the FDA, its partners do, the company said.
“Our laboratory partners have submitted their validation data and reports to the FDA and are operating under the FDA’s Emergency Use Authorizations for these tests,” said an Everlywell spokesperson by email. “The platforms (machines) being used to process patient samples are authorized under the FDA’s EUA as are the assays themselves.”
Anderson said after this was explained to him during a conversation yesterday with Everlywell, it clarified many of his department’s issues with Caldwell's plan.
However, he still thinks the city-funded testing may be unnecessary.
“We now have capacity in our local labs to do most of that testing, so I think things have changed,” he said. “I still have concerns about using a mainland laboratory . . . obviously it would be better to have someone locally respond to patients’ needs.”
He noted that local labs can run about 1,000 tests daily and up to 3,000 tests if there was a surge in need. Results can be returned in one to two days.
Both Anderson and Caldwell said they want to continue discussions on the city’s planned testing.