Miami-Dade was oblivious to FDA warning when it signed giant COVID testing contract with Curative

By Daniel Ducassi, FloridaBulldog.org

Miami Dade County officials signed a multimillion dollar no-bid contract with a COVID-19 testing company in late January – weeks after a nationally publicized FDA alert warning of the risk of false negative results with the company’s tests.

The Food and Drug Administration issued the alert on Jan. 4 about the tests made by California-based company Curative. The FDA specifically advised not to use the test on asymptomatic people, though the test has been widely used that way at testing sites around the country through public contracts worth hundreds of millions of dollars. As a result, the warning generated headlines from national and local news outlets alike, though it attracted scant attention in South Florida.

Despite the news coverage — and the fact that the company was already performing testing for Miami-Dade for months without any written contract — county officials say they were in the dark when the county’s top purchasing official, Namita Uppal, finally signed the COVID testing contract on Jan. 29 on the mayor’s behalf.

“No, we were not aware,” wrote Rachel Johnson, a spokeswoman for MIami-Dade Mayor Daniella Levine Cava, in an email to Florida Bulldog. “As far as I understand it there isn’t an FDA update / notification list that goes to local governments and we weren’t notified by the state or local DOH.”

However, anyone can sign up to get FDA updates emailed to them on the agency’s website.

A wait for answers

The county has been slow to explain what happened. It took three weeks for officials to admit they did not know about the FDA warning when the deal was signed, and more than a month just to provide a copy of the contract to Florida Bulldog.

Curative has been performing testing for the county since Oct. 9, when Levine Cava’s predecessor, Carlos Gimenez, was in the mayor’s office. Johnson insisted there was no written contract at the time, and the county has provided no record of any agreement other than the January contract.

“Throughout the pandemic, we have had to work very quickly to stand up new programs and provide services,” Johnson said. She added that Miami-Dade Fire Rescue, which has been handling testing for the county, told her “it’s not uncommon for us to initiate services while we finalize a contract throughout the COVID state of emergency.”

She explained that the state of Florida, which has also relied on Curative tests, told the county “with short notice that they would be closing testing sites unless we wanted to take them over, around October of last year. We decided we wanted to keep these sites in operation so the state connected us with Curative and they agreed to continue testing while contract was worked out.”

She said the county has processed more than $49 million in payments to the company already, but did not provide any estimate on the total value of the contract.

‘The best interest of public health’

Johnson previously said the county was reconsidering how it used the test after a Florida Bulldog reporter asked the county about the FDA alert. Now, she says the county will keep on using it.

“In consultation with the County’s Chief Medical Officer Dr. Peter Paige, we have determined that continuing to make these tests available to everyone who wants one is in the best interest of public health as we work to fight the spread of the virus and ramp up vaccination,” Johnson wrote.

Asked to elaborate as to why the county believes continuing to use the Curative tests is in the best interests of health, Johnson did not provide any answer.

Local governments have been divided about how to react to the FDA warning. Florida’s Emergency Management Director Jared Moskowitz has expressed his confidence in the state’s use of the test, as has Los Angeles Mayor Eric Garcetti: “This is something that has saved lives, will continue to save lives. And if we move away from it, I worry we would have a lot fewer people diagnosed and even more spread.”

Some have taken a more cautious approach. Days after Garcetti’s defense, Los Angeles County decided to cut back its use of the test. In Colorado, health officials announced they were “concerned about the accuracy” of Curative’s test in light of the FDA statement and would transition away from using the company’s tests.

Though the availability of vaccines is increasing, Miami Dade continues to rely on Curative’s tests as it averages more than a thousand new cases per day and the two-week positivity rate hovers around 7 percent. That’s higher than the 5.5 percent bar that Levine Cava had set in March as the threshold to lift the county’s curfew, which she decided to end without meeting that mark earlier this month.

Levine Cava channels DeSantis

After coming into office last year having cultivated an image as a technocratic liberal, Levine Cava has made pushes to reopen the county in a pro-business approach to the pandemic in recent weeks that’s more reminiscent of the state’s Republican leadership. Earlier this month, she stood with some of South Florida’s most conservative politicians, including her predecessor and now congressman, Carlos Gimenez, along with cruise industry executives to urge the CDC to relax restrictions on cruises. With a similar aim in mind, Republican Gov. Ron DeSantis launched a lawsuit against the federal government to allow cruise ships to sail again.

More recently, the county announced it would loosen social distancing requirements and capacity limits on public buses. In a press release, Levine Cava called it “an important step forward to improve service to our riders, as we work to safely move our economy forward.”

Amid these efforts to get Miami-Dade back to business as usual, the need for reliable testing remains, especially as new variants of the virus spread across the state.

And it’s the reliability of Curative’s tests that the FDA expressed concerns about.

Curative’s PCR test, which looks for the genetic material of the virus, got its first OK from the feds under an “Emergency Use Authorization” last year. The FDA reiterated in its January warning that the authorization “is limited to individuals who have shown symptoms of COVID-19 within 14 days of onset of the symptoms.”

‘Unreasonable risk of harm’

Curative had sought authorization for using the test on asymptomatic people late last year, but emails obtained by Florida Bulldog revealed that an FDA reviewer did not like the data he was seeing from the company.

“Based on this information, we are concerned that your device may put patients at unreasonable risk of harm due to inaccurate results,” he wrote.

The company defended its tests, arguing they’re sensitive enough to catch people who have enough of the virus to infect others, but don’t work as well at identifying people with low amounts of the virus like people with older infections who are no longer contagious but may still have inactive genetic material of the virus, cases the more sensitive comparison tests can catch.

Further data the company provided to the FDA failed to satisfy the reviewer, though the feds stopped short of revoking the original authorization for the test, instead issuing the alert that underscored their guidance not to use the test on asymptomatic people. The CEO of Gothams, a company Curative partners with on testing, told Florida Bulldog that the company had a meeting set up with the FDA on Feb. 10. He later declined to answer questions about the meeting.

When asked how the February meeting went, Curative spokeswoman Miranda Gottlieb wrote in an email, “We continue to actively engage with FDA, but do not have any additional information at this time.”