FDA Lab-Test Review Eliminated, Sturgis Sees Coronavirus Surge. Here’s What You Need To Know About Friday’s Pandemic Developments

The Trump administration on Friday announced it would take away the FDA’s authority to review laboratory-developed coronavirus tests to help improve the speed at which these tests are delivered to the public.

The announcement was made by the Department of Health and Human Services, which determined that the FDA does not have the regulatory authority to approve lab tests for any type of medical condition, including the coronavirus, officials told the Washington Post and Politico.

“A review by the Office of the General Counsel found that the FDA’s assertion is on unfirm procedural and regulatory grounds,” an official told Politico. “They did not gain the authority to regulate LDTs by having gone through a notice and comment rulemaking period, which would be required for an assertion of authority like that.”

FDA was opposed to the decision as they cited test errors without proper review, the Hill said. Others have suggested that the FDA’s review process delays the delivery of these tests, which could be given to the market faster without the agency’s involvement.

The move by the Trump administration adds fuel to building tensions between the HHS and FDA, the Post said. FDA Commissioner Stephen Hahn said the FDA does have the authority to regulate lab tests during a pandemic, the Hill reported.

To date, the FDA has granted 35 emergency-use authorizations as the U.S. reports over 5.6 million positive coronavirus cases and over 173,000 COVID-19 deaths, according to Johns Hopkins University. Globally there are over 22.7 million positive cases of the coronavirus with over 795,000 COVID-19 deaths, data from the university indicated.

In other coronavirus news:

• Former Navy SEAL Robert O’Neill, who has made claims that he was the shooter who killed Osama bin Laden, was banned from Delta Airline’s flights because he wasn’t wearing a face mask. O’Neill posted a photo on social media showing himself on a Delta flight without a mask on surrounded by other passengers wearing masks. O’Neill claimed on social media that his mask was in his lap. On Twitter, he has been a critic of social distancing and other coronavirus safety measures.
• Sweden’s top infectious disease expert has been accused of supporting herd immunity from the coronavirus in a series of emails that were obtained by journalists in the country under the freedom of information laws. The emails, many of which have been deleted, Anders Tegnell said that the death risk from COVID-19 to the elderly population could be “worth it.” Tegnell has denied supporting the idea and told a journalist from the Aftonbladet that “I delete a lot of emails that I do not consider relevant in a way that needs to be recorded.”
• Hawaii has set up what it is calling a “resort bubble” that will allow travelers to Kauai, Hawaii, Maui, and Kalawao to isolate without having to quarantine. The travel requirement will allow residents and visitors to the island to visit together through agreements established with resorts and hotels. Travelers will have to sign waivers and will require electronic monitoring. They will also have to bear the costs of the program.
• CDC Director Robert Redfield said during an interview with Dr. Howard Bauchner of the Journal of American Medical Association that COVID-19 deaths are expected to decrease over the next week. With the COVID-19 death toll averaging at about 1,000 deaths per day, Redfield said he would like to see that number reach 250 deaths per day in the U.S. “You and I are going to see the cases continue to drop,” Redfield said in an interview. “And then hopefully this week and next week, you’re going to start seeing the death rate really start to drop again.”
• The Macy’s Thanksgiving Day Parade will go on in New York City, but Mayor Bill de Blasio hinted that it will be with some changes amid the coronavirus pandemic. He indicated that major alterations to the parade would be needed in November along with the Rockefeller Center Christmas Tree Lighting, both of which garner millions of spectators.

• The National Association of Realtors said July was the biggest one-month jump in home sales that it has seen since December 2006. The association attributes the real estate boom to the easing of lockdowns and a demand to move to the suburbs after the first spike in coronavirus occurred. The report by the NAR showed that sales increased 24.7% from June to July while home prices were up 8.5% from the same period in 2019.
• The Sturgis Motorcycle Rally in South Dakota caused a coronavirus outbreak of at least seven cases in Nebraska, Kim Engel, director of the Panhandle Public Health District, told CNN in an email. The cases appear to have been connected to the rally, which was held from Aug. 7-16. The Sturgis rally also saw a case of the coronavirus from a tattoo artist that may have come in contact with people during the event as well as a bar patron. The city has come under criticism for holding the event that attracted more than 462,000 vehicles, South Dakota Department of Transportation officials said.
• Former FDA official Scott Gottlieb said Friday on CNBC’s “Squawk Box” that there could be a “third act” of the coronavirus in the fall and winter. “I think most peoples’ perception is we had one epidemic in New York, in the New York region, we came down the epidemic curve, we had another epidemic in the Sun Belt, so that really looks like and feels like a second wave,” he said. "I do think that we’re going to have a third act of this virus in the fall and the winter and it’s likely to be more pervasive spread in a broader part of the country."