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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases — and in many ways the nation’s most trusted voice on COVID-19 — is expected to testify on Capitol Hill on Tuesday morning about U.S. plans to reopen workplaces and schools.
Fauci, along with CDC director Dr. Robert Redfield, FDA commissioner Dr. Stephen Hahn and other administration officials, are scheduled to testify via video conference during the Senate Committee on Health, Education, Labor & Pensions hearing.
It’s been roughly two months since state and local officials started issuing stay-at-home orders as a result of growing outbreaks of COVID-19 in the U.S. Schools were closed, events canceled, office workers sent home, and major retailers like Bed Bath & Beyond Inc. BBBY, -4.02% and Macy’s Inc. M, -1.86% closed their doors. New York City, which is widely considered the epicenter of the pandemic in the U.S. and worldwide, is understood to have seen its coronavirus cases peak in mid-April, though the lockdown there is now expected to extend into June. California Gov. Gavin Newsom last week issued new rules aiming at reopening certain retail and manufacturing facilities as cases have flattened in the state.
It’s been under the leadership of Fauci, a physician, longtime HIV researcher, and member of President Donald Trump’s coronavirus task force, that the NIAID conducted the clinical trial for Gilead Sciences Inc.’s GILD, +4.27% remdesivir. The topline results from that trial were released two weeks ago, to much fanfare, when the study found that the experimental drug reduced time to recovery for some severely ill COVID-19 patients.
Fauci tends to play professor to Trump’s brash-talking student and has become a voice of reason for an administration dealing with the political and scientific ups and downs of a virus that has killed nearly 80,000 Americans and sent markets and the economy tumbling.
Here are three questions we’d like to hear from the committee:
How can the U.S. ensure better access to remdesivir?
The Food and Drug Administration two weeks ago granted an emergency-use authorization to remdesivir, making it the first new drug to emerge from a clinical trial conducted during the pandemic that showed an improvement in severely ill COVID-19 patients.
But despite the backing of a large, established drugmaker like Gilead, questions have already cropped up about which patients and hospitals will get access to the drug. Gilead has promised to donate 1.5 million doses, though only about 40% of those doses will stay in the U.S., according to a Health and Human Services statement. (The 1.5 million doses equals 140,000 10-day courses of treatment.) The government disclosed over the weekend that it is allocating the drug to states based on the number of COVID-19 cases; states are then tasked with dispensing to hospitals.
It increasingly appears that the U.S. regulatory process for new medicines plays by different rules during a pandemic. What is the best approach for ensuring remdesivir (and future COVID-19 therapies and vaccines) gets to patients fairly?
Several studies indicate that hydroxychloroquine isn’t helping COVID-19 patients get better. Should the U.S. withdraw the emergency-use authorization for the controversial drug?
Hydroxycholorquine and chloroquine, both previously approved by the FDA as antimalarial drugs, were the first treatments promoted by the Trump administration as having potential in treating people with COVID-19. Other countries, including China, France and Italy, are also testing the drugs in coronavirus patients. However, a series of clinical studies including one published last week found that the drug doesn’t improve outcomes in these patients.
The FDA granted an EUA to these drugs in mid-March, using emergency powers available during the pandemic. However, since then, new medical research has been conducted, and a former official at the National Institutes of Health filed a whistleblower lawsuit alleging that the administration pushed Dr. Rick Bright to promote hydroxychloroquine without “scientific merit” and eventually forced him out of his role at Biomedical Advanced Research and Development Authority.
With an EUA in place and drug makers donating millions of doses of the drugs to the federal stockpile, should the U.S. reconsider promotion or access to these therapies as COVID-19 treatments until positive clinical trial data comes through?
Testing is often cited as key to reopening the economy, but both access and accuracy are common concerns. How will the federal government help increase the number of COVID-19 tests for Americans?
The rollout of COVID-19 tests in the U.S. has been bogged down by glitches since the Centers for Disease Control and Prevention’s initial test had problems back in February. That issue has been addressed, and capacity has increased as some of the nation’s largest diagnostics companies have started developing and shipping their own COVID-19 tests.
That said, there are still lingering questions about access to testing and who will foot the bill to test a population of 330 million people. The early-days testing snafus are a problem that Fauci has himself acknowledged. “We really made somewhat of a sea change here,” Fauci said Sunday on “Meet the Press. “Obviously, early on we weren’t in the situation where we could actually get the test out in a broad way.”
Nearly 9 million tests have been conducted in the U.S., according to data aggregated by Johns Hopkins University, though it’s unclear at this time how many individuals have been tested for the virus. Harvard University researchers have called for at least 5 million tests a day in June and up to 20 million tests a day by July. More than 50 companies have received an EUA for a molecular diagnostics test, and at least 12 have received authorization to market an antibody test, which is used to detect previous infections with COVID-19 rather than identify current infections.
The FDA last week had to rework its regulatory policy for antibody testing after instances of fraud among test makers and growing questions about validation data. Now all diagnostics companies making COVID-19 antibody tests have to seek an EUA.
On Monday, the Trump administration announced $11 billion in funding for states to increase their testing capacity. Fauci and Trump, while speaking to journalists on the Sunday morning shows, talked up a potential ramp-up of testing in the U.S. “Not everybody tomorrow is going to be able to get a test, but pretty soon you’re going to see a major escalation of capability and implementation,” Fauci said.
How does Fauci envision getting more than 3% of the U.S. population tested?
