The US response to coronavirus does not necessarily have the Food and Drug Administration sitting at the coordinating table, despite its key role in fighting and containing the outbreak.
However, like the most recent press conference on the subject, the FDA will be called up to offer its expertise.
Alex Azar, HHS Secretary
Robert O’Brien, assistant to the president for national security affairs
Robert Redfield, CDC director
Anthony Fauci, NIH National Institute of Allergy and Infectious Diseases director
Stephen Biegun, State Department Deputy Secretary
Ken Cuccinelli, Homeland Security Department acting deputy secretary
Joel Szabat, Transportation Department acting under secretary for policy
Matthew Pottinger, assistant to the president and deputy national security advisor
Rob Blair, assistant to the president and senior advisor to the Chief of Staff
Joseph Grogan, assistant to the president and director of the Domestic Policy Council
Christopher Liddell, assistant to the president and deputy chief of staff for policy coordination
Derek Kan, executive associate director, Office of Management and Budget
FDA Commissioner Stephen Hahn stepped into the coronavirus spotlight on 7 February, appearing at a press conference with Health and Human Services Secretary Alex Azar and others. Hahn was not on stage with coronavirus task force members, but was called up from the audience to respond to a question about the medical product supply chain. Hahn said that to date there have been no reports of disruptions related to facilities in China, the center of the outbreak.
“FDA is closely monitoring the situation,” he said. “We're working with our government collaborators as well as manufacturers to monitor what's going on in the supply chain. At this moment we have received no reports from manufacturers about disruptions to the medical product supply chain. Obviously, the situation is fluid and we'll do everything we can to continue to monitor this and act accordingly.”
The comments largely follow earlier assurances from the agency’s drug shortage team that so far, the coronavirus (also known as 2019-nCoV) outbreak is not causing problems for the US drug supply. (Also see "Coronavirus Not Impacting Rx Manufacturing Supply Chain – Yet" - Pink Sheet, 29 Jan, 2020.)
The agency has discussed its activities since the outbreak began, created a website with updates and resources, but was not included on President Trump’s coronavirus task force. The 12 spots were given to Azar, Centers for Disease Control and Prevention Director Robert Redfield, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, and others. (See box.)
The FDA, HHS and White House would not explain why the FDA was not a member of the task force. The move seemed a bit odd, given that the FDA’s role in the response. The agency already has provided an emergency use authorization for a CDC coronavirus diagnostic and is helping streamline the development of vaccines and other countermeasures.
The reason may be that there simply were not enough seats at the President’s table. Anand Parekh, chief medical advisor at the Bipartisan Policy Center, told thePink Sheetthat HHS likely has its own intra-department leadership team that includes Hahn.
And while the response to the outbreak should not be distracted by jockeying for screen time, from a strictly logistical perspective, keeping the FDA in the loop would seem to be warranted. Indeed, even without a seat at the task force table, FDA will have close to the first and last word in the government's response to the outbreak – from authorizing the initial diagnostic to eventually, everyone hopes, approving a vaccine.
The coronavirus outbreak is among Hahn’s first high-profile public appearances since taking office in December. (Also see "New US FDA Commissioner Stephen Hahn Heads to White Oak Under Vaping Cloud" - Pink Sheet, 12 Dec, 2019.) While he has conducted media interviews and given speeches internally, Hahn has not spent a lot of time in public view so far. (Also see "Hahn's Priorities For US FDA Eschew Hot-Button Issues, Focus on Traditional Themes" - Pink Sheet, 30 Jan, 2020.)
Aside from providing the EUA for the first coronavirus diagnostic, the FDA also soon could be monitoring and preparing for clinical trial results for a treatment.
Fauci said during the press conference that a randomized control trial comparing treatment withGilead Sciences Inc.’s antiviral remdesivir plus the standard of care to remdesivir alone has started in China.
Moderna Inc.also is developing a messenger RNA vaccine against the coronavirus. (Also see "Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives" - Pink Sheet, 29 Jan, 2020.)
Fauci said so far there have been no glitches in efforts to insert the necessary gene into the messenger RNA and use it in an animal model. He said if all continues to go well, Phase I trials in humans could begin in two months.
In addition,GlaxoSmithKline PLCis lending adjuvant expertise to the Coalition for Epidemic Preparedness Innovations, a Norwegian public-private organization, to aid vaccine development. (Also see "GSK Joins Race To Tackle Coronavirus" - Scrip, 3 Feb, 2020.)
While the government is enforcing travel restrictions to contain the virus’ spread into the US, the FDA is warning that its visitors also may face scrutiny.
The agency wrote on its website that because of the public health emergency, “visitors to FDA campuses and buildings may be asked questions related to recent international travel.”
The virus is not an immediate threat in the US, but the statement suggests that sponsors may have to closely scrutinize the representatives they chose to send to the FDA headquarters in Maryland for in-person meetings.
In addition, the US has offered to send a team of experts to China to assist in their response and learn more about the virus. Azar said the Chinese government has not decided whether it will allow them there, although he expects eventually access will be granted.
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