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by Sharon Rondeau

FDA Commissioner Dr. Stephen Hahn, Wikimedia Commons, public domain

(Apr. 5, 2020) — On today’s “Sunday Morning Futures,” FDA Commissioner Dr. Stephen Hahn explained the process by which the agency he heads approves usage of new equipment, after which host Maria Bartiromo asked for a “status check” given that President Trump and the White House Coronavirus Task Force on Saturday predicted the coming week will be a particularly difficult period as the coronavirus pandemic continues to unfold.

“First of all, I just want to reiterate what the president and the Task Force members said yesterday: that mitigation appears to be working; we’re beginning to see signs of that,” Hahn responded. “It’s really important for everyone to continue to follow that, and I think the American people have done a great job.”

“Mitigation” involves “social distancing,” or remaining home as much as possible and staying six feet apart from others in grocery stores and other public places to “slow the spread” of coronavirus.

Most states’ mitigation strategies came in the form of gubernatorial executive orders closing schools and most businesses beginning in March along with “stay-at-home” recommendations.

Regarding Bartiromo’s question about the FDA process involved in approving new medical products, including those made by “foreign actors like China,” Hahn said, “With respect to the issue of red tape, this is always a balance, but what we’re doing is trying to remove as much unnecessary regulation as possible to speed medical products to the American people.  At the same time, the American people depend upon us to actually ensure that medical products are safe and effective.  So we’re doing both; it’s an all-hands-on-deck approach to it, and we’re working very closely with the private sector to make sure that that happens.”

As to N95 masks being sent to the U.S. from China which the FDA said it will approve for use, Bartiromo asked Hahn the agency’s role in evaluating products manufactured outside the country. “What we do is we assess each medical product as it comes before us,” he replied. “We want to make sure that it’s appropriate for its intended use, so some products may be labeled as one thing but we know that they could be used for something else.”

As an example, Hahn said the FDA recently approved a mask which he described as “a typical mask that’s used in industry.” The FDA determined it “could be used in the medical setting as long as it wasn’t used in certain conditions where it wasn’t necessarily protective,” Hahn said.  That assessment, he said, was coordinated through consultation with the Centers for Disease Control and Prevention (CDC).

“Previously, we hadn’t permitted that,” Hahn added.

“We’re asked every day to look at specific foreign products,” he continued.  “We look at their specifications, and then we match that to the appropriate condition for American providers and American patients.”

Bartiromo then asked Hahn if the U.S.’s dependency on China to manufacture its drugs is “all about money.”  “Why are we still so reliant on China, and how are you going to change this?” she added.

The FDA “doesn’t have the authority to determine where things are manufactured,” nor can it prevent an American manufacturer from going overseas, Hahn responded. He added that the FDA found “many months ago” that “We really need redundancy in the medical product supply chain.”

“It’s incredibly important in prescription drugs; it’s incredibly important with ventilators; it’s incredibly important with masks,” he expounded.  “We cannot be dependent upon any single country, and we need what’s called ‘redundancy’ in our manufacturing.”

Bartiromo asked Hahn if he believes China will develop a coronavirus vaccine before the United States, and if so, whether or not the FDA would consider approving it for use here.

“We are prepared to look at any data around any medical product and in particular, vaccines, because that’s obviously the answer for the next season, at any time that those data become available,” Hahn responded. “What I can assure the American people is that we will look at all the data and science; it’s our job to make sure that that data and science show us that a vaccine, in this particular case, is safe and effective.”

He reported the FDA has been engaged with vaccine manufacturers for a number of weeks, working at “record speed” to develop one for the coronavirus.

As for “prophylactics,” Bartiromo asked how soon drugs or “a shot” might be available so that those who have developed an immunity to the virus might be determined as part of a strategy to reopen the U.S. economy.

In his response, Hahn said, “We absolutely need to get back to work” while keeping in mind “public health issues.” He said that “for the last two months,” the FDA has been working on using “convalescent plasma,” which is taking blood plasma from recovered patients and injecting it into ill individuals.

“Hyper-immune globulin,” he said, potentially “can work as a therapeutic” in the form of “a shot” he said. That strategy, he maintained,  “acts as a bridge to get us to a vaccine.”  “Again, we have to study it,” Hahn said, “and we’re doing this quickly.”

Another possible treatment is “monoclonal antibodies,” which are “genetically-engineered,” and the FDA is working with companies with experience in that area, Hahn added.

Bartiromo asked if a story appearing in “state-run” Chinese media suggesting that the U.S. will not receive the drugs upon which it depends and that vital drugs may be “in short supply” is accurate, to which Hahn replied, “We have on our website a list of drugs that are in short supply, and that’s been ongoing for some time…” He said the FDA is not aware of “any evidence that there’s a drug in short supply because of anyone blocking the active pharmaceutical ingredients coming to us. But what I can tell you is that we are monitoring that very closely.”

Hahn reiterated that the “long-term solution” is to rectify “redundancy in our manufacturing” as well as domestic manufacturing of drugs on which the United States depends.

Regarding the prospect of collecting data on individuals who have had the coronavirus, Hahn said he “is confident” the FDA is prepared to handle the task but that “this is going to happen in partnership with the private sector.”

On coronavirus testing, Bartiromo posited that the U.S. could improve, a point with which Hahn agreed based on reports he said he has received.  He called the process “complicated” and said that “supplies, reagents, and a number of different platforms,” meaning “machines that run the tests,” render it so.

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