FDA’s Hahn Addresses Coronavirus Test Capacity, Drug Shortages at Senate Hearing
As the number of new coronavirus cases in the US increases, experts from the US Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) discussed the current state of affairs with the Senate Health, Education, Labor and Pensions Committee on Tuesday morning.One of the biggest questions for the panelists, which was rephrased and repeated by multiple senators, focused on coronavirus testing and a claim by FDA Commissioner Stephen Hahn late Monday that the US should have the capacity to perform about 1 million tests by the end of this week.
Hahn broke that capacity number down by explaining that there should be about 2500 kits by the end of the week, with 500 tests per kit, but he stopped short of offering further details on the number of people who might be actually tested.
Sen. Maggie Hassan (D-NH) questioned FDA’s messaging on the tests, which she said “has been confusing and contradictory over time. The FDA needs to ensure its communications are clear to the public.”
Sen. Patty Murray (D-WA) also raised concerns about a lack of diagnostic testing in her state, which now has seen nine coronavirus-related deaths.
The Association of Public Health Laboratories told Focus that as of 10 a.m. on Tuesday, 54 (of the 100) local and state public health labs have been verified and are able to begin coronavirus testing. These public health labs can test 100 patients per day, and when fully online that will mean testing capacity will be 10,000 patients per day.
Hahn noted that FDA is working with 65 other test developers to increase capacity and availability and that further emergency use authorizations (EUAs) may be issued.
As far as when the CDC will no longer have to perform confirmatory testing on state coronavirus tests, CDC’s Anne Schuchat said that “should come very soon.”
Shortages of personal protective equipment were also highlighted, and late Monday, FDA granted the CDC’s request for an EUA to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak in health care settings. The WHO also said Tuesday that manufacturers of personal protective equipment need to increase manufacturing by 40% to help with the shortages.
Hahn also touched on FDA’s inability to disclose a drug shortage related to the coronavirus, explaining that it’s expected to be resolved shortly and that patients have alternatives. This specific shortage is related to a chemical, and not the active pharmaceutical ingredient, he said. He also said the agency has been in touch with 180 drug manufacturers and 63 device manufacturers to learn about supply chain updates.
And just this morning, he also noted that FDA found out that India is restricting the export of 26 pharmaceutical ingredients and drugs made from them because of fears of domestic shortages. Hahn said FDA is “investigating that list to see how it’ll impact the supply chain.”
The list includes the pain drug paracetamol, the antibiotic tinidazole, acyclovir, as well as vitamins B1, B6 and B12.
Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, also explained to senators that, “We should know in a few months” whether Gilead’s antiviral drug remdesivir is an effective coronavirus treatment. But on the vaccine side, development will take at least a year, even as one of the vaccines in development is expected to enter a Phase 1 trial in two to six months.
Gilead CEO Daniel O'Day told President Donald Trump on Monday that his company expects early results from its trials in April. The company is running two trials in China with 400 patients in each, and "getting close to halfway enrolled," he said.
Senate HELP hearing