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FDA Resistance, CDC Guidelines, and Avoidable Tragedy
In this email:
* The FDA Resists White House Pressure
* Updated CDC Guidelines
* Patient Zero of Coronavirus Misinformation


American Oversight’s Covid-19 Oversight Hub ([link removed]) provides news and policy resources to help you keep track of the investigations into the government’s pandemic response. The project brings together a public documents database, an oversight tracker of important ongoing investigations and litigation, regular news updates, and deeper dives into key issues.

News Update

The FDA Resists White House Pressure
Last week, both Health and Human Services Secretary Alex Azar ([link removed]) and President Donald Trump ([link removed]) said they expect a vaccine will be available by the end of this year. But according to the New York Times, officials at the Food and Drug Administration, which must approve a prospective coronavirus vaccine, have resisted the administration’s rapid vaccine timetable.

The Times reported ([link removed]) last week that FDA Commissioner Stephen Hahn has recently held out against political pressure from Trump, Chief of Staff Mark Meadows, and Senior Adviser Jared Kushner, who each have urged him to accelerate emergency authorization of vaccines and treatments. But the FDA earlier this month published stricter vaccine guidelines the White House had initially opposed, and Hahn has requested that all calls from White House officials be routed directly to him. Politico reported ([link removed]) that Azar, angry over the FDA’s acts of independence, has even floated the idea of firing Hahn — a move that, while unlikely to occur before the election, would allow Azar greater influence over the vaccine approval process.

FDA Experts Call for More Rigorous Vaccine Review
The FDA publicly aired ([link removed]) the first coronavirus-related meeting of the Vaccines and Related Biological Products Advisory Committee last Thursday. The committee, which is made up of independent scientific experts, advises the FDA on vaccine licensure processes. Although the FDA is not bound to the committee's advice, it does typically follow ([link removed]) its recommendations.

At the committee’s Thursday meeting, members expressed skepticism ([link removed]) about some of the FDA’s vaccine-related requirements thus far. Some said they would like to see stricter standards and efficacy measures more focused on severe Covid-19 infection, rather than mild cases of the disease. Members were also concerned that the FDA’s new requirement that Phase 3 trials involve at least two months of data was too short.

Updated CDC Guidelines
Last week, the Centers for Disease Control and Prevention expanded recommendations about mask-wearing. In the updated guidelines ([link removed]) , the agency strongly recommended that all passengers and workers on planes, trains, and other forms of public transportation wear masks to limit the spread of the coronavirus. Last month, the White House blocked ([link removed]) the CDC from issuing an order that would have required all passengers and employees to wear masks on all forms of public transportation.

The CDC also expanded ([link removed]) the definition of who is considered a “close contact” of an infected individual. Previous definitions defined “close contact” as someone who has spent at least 15 consecutive minutes within 6 feet of a confirmed coronavirus patient, but the updated guidance changed this time requirement to a total of 15 minutes over a 24-hour period. The guidance was updated following the report ([link removed]) of a prison employee in Vermont who contracted coronavirus through brief repeated interactions.

Congress Releases White House Coronavirus Task Force Reports
The House Select Subcommittee on the Coronavirus Crisis obtained and released ([link removed]) six weeks of White House Coronavirus Task Force reports last week. These reports, shared privately with state governments each week but not released to the public, revealed that the White House had long been aware of rising Covid-19 cases nationwide: The first released report, from Sept. 13, warned that 18 states were in the “red zone” for test positivity; the report from Oct. 18 put 31 states in the red. The reports also include recommendations for increased testing and mask-wearing.

EPA Refuses to Reduce Pollutants Linked to Covid-19 Deaths
In April, Environmental Protection Agency Administrator Andrew Wheeler rejected scientific advice to tighten air pollution standards for fine particulate matter, which has been linked to conditions like asthma and chronic obstructive pulmonary disease. Researchers have also found correlations between elevated presence of this matter and high Covid-19 mortality rates. ProPublica reported ([link removed]) that despite this evidence, Wheeler, who has loosened reporting requirements for air polluters, is expected to reaffirm his April decision in the coming weeks.

OSHA Policies Abandoned Meatpacking Workers
The New York Times reported ([link removed]) that during the pandemic, lax Occupational Safety and Health Administration oversight empowered meatpacking companies to keep plants open, putting workers at serious risk in the process. To date, OSHA has announced more than $1 million in coronavirus-related penalties for dozens of health-care facilities and nursing homes. But it has fined only two meatpacking plants: JBS and Smithfield Foods. The multibillion-dollar companies faced small penalties that totaled less than $30,000. See also: Emails Reveal Meat Industry Influence over Government’s Pandemic Response ([link removed]) .

Patient Zero of Coronavirus Misinformation
A Cornell University study ([link removed]) has found that Trump is the single-largest driver of coronavirus misinformation. Recent analyses ([link removed]) have also shown that his visits around the country have often been followed by community spikes ([link removed]) in Covid-19 cases. Documents obtained by American Oversight reveal how many of the associated large events defied local recommendations ([link removed]) and were expected to spread ([link removed]) the virus.

U.S. Could Have Avoided More Than 100,000 Covid-19 Deaths
A report by Columbia University's National Center for Disaster Preparedness ([link removed]) compared the U.S. policy response to Covid-19 to six similarly high-income countries: South Korea, Japan, Germany, Australia, France, and Canada. The report suggests that if the U.S. had followed protocols similar to the other countries, such as building sufficient testing capabilities, enacting earlier lockdowns, and issuing a nationwide mask mandate, between 130,000 and 210,000 Covid-19 deaths could have been avoided. As of writing, U.S. deaths total more than 220,000.

Congressional Investigations

White House Interference at the CDC and FDA: The Government Accountability Office will investigate ([link removed]) whether Trump administration officials improperly interfered with the coronavirus response at the CDC and FDA. The GAO will review whether the CDC and FDA’s scientific integrity and communications policies have been violated.

Administration’s Shipments of Ventilators to and from Russia: The House Committee on Oversight and Reform, House Committee on Foreign Affairs, and the Select Subcommittee on the Coronavirus Crisis wrote a letter to State Department Acting Inspector General Matthew Klimow and Department of Homeland Security Inspector General Joseph Cuffari requesting an investigation ([link removed]) into the shipments of ventilators to and from Russia during the early stages of the coronavirus pandemic. In April, the Federal Emergency Management Agency accepted 45 Russian ventilators that were unsafe for use in the U.S.; less than two months later, the U.S. sent 200 ventilators to Russia at a cost of $5.6 million in taxpayer money.
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