Coronavirus Roundup: Lawmakers Probe ‘Operation Warp Speed’ Contract; FDA Commissioner Clarifies Comments on Convalescent Plasma Treatment

Speakers during the first night of the Republican National Convention on Monday championed President Trump’s efforts to manage and respond to the pandemic and refuted many of the points raised at the Democratic convention last week. “The devastating effects of the coronavirus demanded immediate changes at the regulatory level. A prompt response led by President Trump cleared away the red tape that usually makes drug approvals a long and drawn out process,” said Dr. G.E. Ghali, chancellor of Louisiana State University Health Sciences Center and oral and maxillofacial surgeon who had coronavirus. 

“By harnessing the resources of the federal government and the private sector, President Trump’s ‘Operation Warp Speed’ is accelerating the testing, supply, development and distribution of therapeutics, diagnostics, and very shortly, effective vaccines,” he said. Here are some other recent headlines you might have missed. 

Food and Drug Administration Commissioner Stephen Hahn’s hiring of a former employee at the Heartland Institute as a senior adviser is the latest “controversial” hire at the agency, Stat News reported on Tuesday. David Gortler wrote in a 2016 op-ed that there should be widespread firings at the FDA because it “has its share of petty people who have personal agendas against fellow FDA employees and/or pharmaceutical companies.” He also expressed opinions that could anger the pharmaceutical industry as well. 

On Monday evening, Hahn walked back comments he made on Sunday about the efficacy of blood plasma treatment for COVID-19 victims and FDA’s decision to grant emergency authorization for it. He said the decision was made by career scientists based on data and that the FDA is continuing to study its effectiveness. “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn tweeted. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.” His initial mischaracterization sparked outcry among scientists, who said it “grossly misrepresented” the data, the New York Times reported.

Sens. Elizabeth Warren, D-Mass., and Richard Blumenthal, D-Conn., and Rep. Pramila Jayapal, D-Wash., pressed the Health and Human Services Department for information about the third-party contract that Moncref Slaoui, chief advisor for “Operation Warp Speed,” is working under. “Dr. Slaoui’s arrangement means that Congress and the American people are blocked from fully understanding the value or nature of Dr. Slaoui’s conflicts and financial holdings as he plays a central role in the search for a safe and effective vaccine,” they wrote on Monday. “This lack of transparency, and the clear existence of unresolved conflicts, threaten to undermine Americans’ confidence in [‘Operation Warp Speed’] entirely.” 

The lawmakers also sent a letter to Advanced Decision Vectors, the company under which Slaoui is contracted, seeking clarity about the company’s role. “Nor is it clear how it is in the company’s interest to serve as the middleman in a scheme that appears to be designed solely to allow a high-level scientist involved in [‘Operation Warp Speed’] to avoid addressing his serious financial conflicts of interest,” they wrote. 

The Environmental Protection Agency has granted thousands of oil and gas companies, government facilities and other entities authority to bypass environmental regulations due the pandemic, The Associated Press reported on Monday. After facing pressure from the oil and gas industry, on March 26, EPA waived enforcement of various public health and environmental regulations, arguing that companies could have issues complying with them due to the pandemic. According to the report, EPA said it will end “enforcement clemency” this month, noting the waivers do not authorize recipients to exceed pollution limits. “But environmentalists and public health experts say it may be impossible to fully determine the impact of the country’s first extended, national environmental enforcement clemency because monitoring oversight was relaxed,” AP reported. 

On Monday, Sens. Elizabeth Warren, D-Mass., and Edward Markey, D-Mass., asked EPA to provide information on the administration's environmental rollbacks during the pandemic. “As the Trump administration has now set an end date for its suspension of environmental enforcement, the EPA must explain to the public how regulated industries maintained records during the enforcement moratorium and why the agency declined to commit to conduct retrospective enforcement reviews,” they wrote. “The administration must also review and explain how environmental health potentially deteriorated amid the crisis and its lack of enforcing environmental regulations.” 

Sen. Gary Peters, D-Mich., ranking member of the Senate Homeland Security and Governmental Affairs Committee, introduced a bill on Monday that would allow FDA to recall unsafe products. Currently it can only make recommendations for companies to do so. The agency recently recommended the recall of more than 100 toxic hand sanitizer products, “but some companies failed to comply,” said the press release. 

The Agriculture Department appointed Sherri Williams, a health overseer at the food processing company JBS, to a national advisory committee on meat inspections. The move comes “just months after JBS had to temporarily idle meat mills in Colorado, Nebraska, Wisconsin, Minnesota, and Pennsylvania because of outbreaks of the novel coronavirus among workers, The Daily Beast reported on Monday. “The company also suffered severe rashes of the disease in its facilities in Utah and Texas, and its uniquely troubled history made the appointment a remarkable one during a still-raging pandemic.” 

The National Institutes of Health will study biotechnology company Gilead Sciences’ compound that some say is similar to remdesivir, the only drug proven to treat the coronavirus thus far. The company has “deemphasized” this potential treatment, but researchers and academics urged NIH to study it based on promising lab results, Stat News reported on Monday. 

Will Brady, a top HHS official serving in two roles, will leave the administration in the coming weeks, Politico reported on Tuesday. Brady is the chief-of-staff to deputy secretary Eric Hargan and senior adviser to Secretary Alex Azar on technology. Brady “will leave HHS a better-managed, more efficient department,” Hargan told Politico. Brady’s work on expanding telehealth and distributing provider relief payments “helped save much of the U.S. health care sector during the outbreak,” Hargan told the publication.

The Defense Department will be issuing updated identification cards for military family members and retirees for the first time since 1993. The cards will be ready by December but bearers have until 2026 to transition to the new ID cards, the department said on Monday. 

Today’s GovExec Daily podcast episode is about how to have meaningful conversations with those who hold different beliefs. 

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