HHS Secretary: Coronavirus in China Could Produce 'Disruptions' in Medications Americans Need

By Susan Jones | February 26, 2020 | 10:52am EST
Health and Human Services Secretary Alex Azar. (Photo by ANDREW CABALLERO-REYNOLDS/AFP via Getty Images)
Health and Human Services Secretary Alex Azar. (Photo by ANDREW CABALLERO-REYNOLDS/AFP via Getty Images)

(CNSNews.com) - "The degree to which some of our own manufacturers rely on China to produce life-saving and life-sustaining medications is inexcusable," Sen. Josh Hawley (R-Mo.) tweeted on Tuesday.

On Wednesday, Health and Human Services Secretary Alex Azar admitted that "there could be disruptions in supplies" of critical medications and ingredients as the coronavirus spreads in China.

"What should we be doing in the United States to ensure the safety of the American drug supply?" Rep. Kay Granger (R-Texas) asked Azar, who appeared before a House Appropriations subcommittee:

"This has brought to light the issue of the complete internationalization of the supply chain, not just for medical products, but really across all of the economy," Azar replied.

And so what we're doing now is, the FDA is reaching out to all pharmaceutical manufacturers, device manufacturers, etc., to make sure we've got visibility.

The latest fruits of that work show that there are 20 pharmaceutical products we are aware of to date at FDA where either the entire product is made in China or there is a critical, active ingredient that is solely sourced within China.

(According to Axios, "About 150 prescription drugs — including antibiotics, generics and some branded drugs without alternatives" — may be in short supply here if the coronavirus worsens in China. Axios quoted "two sources familiar with a list of at-risk drugs compiled by the Food and Drug Administration.)

Azar on Wednesday mentioned 20 pharmaceutical drugs or ingredients the FDA is most concerned about, but he did not say what they were.

"To date, we are not aware of any expected shortages, and we have aggressively, proactively reached out to manufacturers for that information," Azar continued:

I'm told there are two manufacturers in Hubei Province [ground zero for the coronavirus] of pharmaceuticals, but fortunately the manufacturer has a large, large stockpile supply of advance production there. But we have to be very alert to this, and we have to be candid that there could be disruptions in supplies.

We already experienced that, of course, with medical shortages, generic shortages, due to sole source producers, manufacturing, the effects of inspection problems, and we've got an aggressive agenda for shortages that we've worked with this committee and authorizing committees on to help alleviate shortages.

Sen. Hawley, meanwhile, says he's introducing legislation "to protect our medical supply chains & critical drugs during the #CoronavirusOutbreak and bring them back from #China."

On Monday, Hawley wrote to Food and Drug Administration Commissioner Dr. Stephen Hahn, expressing "alarm" about the security of the U.S. medical product supply chain:

"The degree to which some of our own manufacturers rely on China to produce life-saving and life-sustaining medications is inexcusable," Hawley wrote. "It is becoming clear to me that both oversight hearings and additional legislation are necessary to determine the extent of our reliance on Chinese production and protect our medical product supply chain."

Hawley urged the FDA to take "swift action" to mitigate potential pharmaceutical shortages, and he asked for a quick response to the following questions:

-- What actions has the FDA taken to date to ensure that American citizens do not face shortages of life-saving drugs and medical devices?

-- What actions will the FDA take in the coming weeks and months to ensure that safe alternatives to any scarce medical products are available for public use?

-- What additional resources has the FDA devoted to identifying vulnerabilities in the U.S. medical product supply chain?

-- What additional statutory authority, if any, does the FDA need to require information from manufacturers about the sourcing of component parts, active pharmaceutical ingredients, or scarce raw materials in the medical products they produce?

--Will you commit to testifying in congressional hearings about these troubling vulnerabilities in our medical product supply chain and potential policy solutions to keep Americans safe?



 

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