Coronavirus Roundup: FDA Pauses Plasma Treatment Authorization; Defense Continues Sexual Assault Survivor Services During Pandemic
This article features Government Accountability Project and was originally published here.
During his Democratic National Convention speech on Wednesday night, former President Obama gave a sharp rebuke of President Trump’s governing and response to the pandemic. “Donald Trump hasn’t grown into the job because he can’t,” Obama said. “And the consequences of that failure are severe.” Nominees Former Vice President Joe Biden and Sen. Kamala Harris, D-Calif., will “get this pandemic under control, like Joe did when he helped me manage H1N1 and prevent an Ebola outbreak from reaching our shores,” Obama said. Meanwhile, Trump fired back with tweets during the event. Here are some other recent headlines you might have missed.
On Wednesday, three Democratic senators called on the Health and Human Services Department and Centers for Disease Control and Prevention to issue guidance for colleges and universities to report their coronavirus cases. “This lack of guidance is likely to create a patchwork of inconsistent information across states, localities and the nation, undermining transparency and efforts to address the pandemic,” wrote Sens. Elizabeth Warren, D-Mass.; Tina Smith, D-Minn.; and Chris Murphy, D-Conn. They also asked for information by Sept. 2 about how the agencies plan to study outbreaks on campuses as students are starting to return.
Sens. Ron Johnson, R-Wis.; Mike Lee, R-Utah; and Ted Cruz, R-Texas, wrote the Food and Drug Administration on Wednesday to inquire why it issued then revoked emergency authorization for the drugs hydroxychloroquine and chloroquine to treat the coronavirus. “The licensed physicians we have heard from have stressed the potential benefits of early outpatient treatment of HCQ for individuals infected with COVID-19…[and] are concerned that the FDA’s actions regarding HCQ may be directly costing lives,” they wrote. In the letter, the senators cite a research website that says it is “censored by Facebook” and claim it is wrongly accused of posting false information. President Trump has been touting these drugs, despite a lack of evidence they can treat the coronavirus effectively.
The FDA was about to issue emergency approval of blood plasma treatment for the coronavirus, but then put it on hold last week because top public health officials (such as Dr. Francis Collins and Dr. Anthony Fauci) said the data on the trials was not strong enough, The New York Times reported on Wednesday. During a briefing on Wednesday evening, the president said, “I hear great things about” the treatment. “It could be a political decision, because you have a lot of people over there that don’t want to rush things because they want to—they want to do it after November 3rd.”
The FDA and Occupational Safety and Health Administration published a checklist on Wednesday for considerations human and animal food manufacturers should take in deciding when to resume or reevaluate operations. This includes how to configure workspaces, ensure employee safety and investigate exposure, and determine if employees need to be tested.
The Trump administration is now allowing coronavirus tests developed by individual laboratories to be used without FDA approval. “Two senior administration officials told Politico that the new HHS policy is not specifically aimed at relaxing rules for coronavirus testing,” but rather “based on HHS’ determination that FDA does not have the authority to regulate lab-developed tests for any condition, including Covid-19,” Politico reported on Wednesday. “The policy change has been a major point of tension for weeks between HHS and FDA, according to sources familiar with the debate.”
Moncef Slaoui, co-director of administration’s “Operation Warp Speed,” told Business Insider on Wednesday that a coronavirus vaccine would likely be available widely by spring or early summer 2021. He also expressed frustration over certain companies touting misleading ties to “Operation Warp Speed,” which led to their share prices increasing.
Sen. Elizabeth Warren asked the Pandemic Response Accountability Committee, established by the $2.2 trillion CARES Act, to review the administration’s $765 million loan to the photography company Kodak to produce pharmaceutical ingredients. The Securities and Exchange Commission launched an investigation into the loan earlier this month about how the company disclosed the loan, which prompted the administration to put it on hold. “The fiasco surrounding the decision to offer, then revoke, the Kodak loan also raises larger questions about corruption, nepotism and mismanagement in the Trump administration’s response to COVID-19,” Warren wrote.
Nonprofits Open The Government and the Government Accountability Project filed a lawsuit against HHS and CDC to compel them to release their Freedom of Information Act requests for pandemic communication strategy records. “If the White House gagged scientific experts from communicating with the public, we want those records. Science shouldn’t be muzzled,” tweeted Irvin McCullough, deputy director of legislation and national security analyst at the Government Accountability Project.
As a result of the ongoing pandemic, the Defense Department is working to expand telework capabilities for those who deal with classified material. Read NextGov’s full coverage here.
On Wednesday, the Defense Department outlined how it has not ceased its work to provide services for sexual assault survivors during the pandemic and has made some modifications to limit in-person contact and accommodate the travel restrictions. “The COVID-19 pandemic has changed all of our lives. However, one thing that hasn’t changed is our commitment to helping our warriors and their families who may be seeking assistance with an experience of sexual assault,” said Dr. Nate Galbreath, acting director of the Sexual Assault Prevention and Response Office. “We want to assure everyone in the DoD community that we are still here to support them on their healing journey.”
A bipartisan group of almost 100 former national and homeland security experts called for a mission reset at the Homeland Security Department to focus on non-military threats. This was in a report for the Atlantic Council’s Scowcroft Center for Strategy and Security, Federal News Network reported on Wednesday. One example is the pandemic, which has “not yet received the leadership attention and resources it deserves [and] the American people are paying a terrible price as a result,” said the report. “DHS needs to take a stronger leadership role in mobilizing resources and public support to defend the nation from Covid-19 and future pandemics.”