FDA Official Warns Coronavirus on Path to Becoming Pandemic

(Bloomberg) -- The coronavirus outbreak that began in China and has spread through the world and into the U.S. is on track to become a pandemic, a top official at the Food and Drug Administration warned.

“For all intents and purposes, I think it’s fair to say we are on the cusp of the pandemic,” Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said in an interview. “Is it definitely going to happen? No, but there is significant concern, as of overnight we have cases on six continents.”

While the U.S. has so far seen a smaller number of cases compared to hotbeds for the virus in China, U.S. regulators are ramping up measures to combat the anticipated spread of the outbreak, Marks said ahead of a keynote presentation at the SVB Leerink Global Healthcare Conference in New York.

“As you heard from the CDC yesterday, they’re kind of bracing for what might happen,” Marks said. “From our standpoint at FDA, our goal is to maintain things as orderly as we can and try to maintain adequate amounts of supplies in the supply chain.”

The FDA is looking for alternative sourcing and manufacturing of things like medical devices and key drugs given the shutdown in China, Marks said. “We’re dependent, for some of our medical products 90 percent or more, on imports,” Marks said, highlighting items like syringes, masks and gowns.

Cases Rising

Increasing numbers of cases outside of China have raised risks for the U.S. and put health officials on high alert for the potential of a global pandemic. Earlier this morning, Brazil confirmed the first case in Latin America and the count of infections in Italy rose to more than 380.

Hours after Marks’s initial comments and keynote remarks, he released a statement to Bloomberg News expanding on the public health risks from the coronavirus.

“Outbreaks of novel virus infections among people are always of public health concern. The potential public health threat posed by COVID-19 is high, both globally and to the United States. However, for the general American public, who are unlikely to be exposed to this virus at this time, the immediate health risk from COVID-19 is considered low. U.S. public health agencies are preparing for all potential scenarios to best protect the American public,” Marks said in the statement.

Concerns about the spread of the coronavirus have consumed everything from corporate earnings updates to presentations and panels at the SVB Leerink event. Cody Meissner, an infectious disease expert and professor of pediatrics at Tufts University School of Medicine, said during a panel that “there are probably more cases in the U.S. than we acknowledge.”

A number of companies are rushing to develop potential medicines and vaccines to combat the coronavirus. Marks echoed sentiment from a senior World Health Organization official and highlighted developments from Gilead Sciences Inc.’s experimental drug remdesivir.

“When you have such a large outbreak like you have in China, you can effectively study these things in randomized trials reasonably efficiently,” he said. “And we may have an answer in the not too distant future about whether theres an antiviral agent that could work.”

Gilead said Monday it is anticipating results from two trials in China in April. While shares of vaccine developer Moderna Inc. have continued to skyrocket on hopes for its medicine, Marks advised that “this initial wave will be over before there is an effective vaccine.”

A key update from the White House will come later Wednesday, when President Donald Trump and federal health officials plan to hold a public briefing on the coronavirus and efforts to prevent the spread of the virus. On Tuesday, Trump and economic adviser Larry Kudlow portrayed the outbreak as a problem largely held outside of the U.S.

Follow TOPLive for our blog of Trump’s briefing, starting at 6:30 p.m.

To contact the reporter on this story: Bailey Lipschultz in New York at blipschultz@bloomberg.net

To contact the editors responsible for this story: Catherine Larkin at clarkin4@bloomberg.net, Jennifer Bissell-Linsk, Courtney Dentch

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