Public health experts identify drug manufacturing as a top vulnerability in the fight to contain the coronavirus in the United States

by Lindsay Russell // February 13, 2020

WASHINGTON – A panel of public health experts testified on Wednesday before the Senate Committee on Homeland Security and Government Affairs that the United States does not have the resources to handle a global outbreak like the novel coronavirus.

The panel agreed that one of the most serious threat the U.S. would face in the instance of a global pandemic would be the inability to produce enough pharmaceutical drugs and medical supplies to sustain the U.S. population.

Dr. Scott Gottlieb, former commissioner of the Food and Drug Administration under President Trump, explained the process of drug manufacturing. The U.S. manufactures drugs insofar as putting active pharmaceutical ingredients (API) into tablets or syringes for vaccines, but China is often the “sole supplier” of the chemicals that create the API.

“What we’re finding now is, in many cases, China is the only supplier of these raw ingredients,” Gottlieb said. “What we’ve identified is a critical chokepoint in the supply chain.”

This means that in the case of a global pandemic, the Chinese government would not export the API needed to create vaccines and antibiotics until their local need for the drugs was sufficiently met, Gottlieb said.

Most drug-manufacturing companies typically have between one and three months of API on hand, which means that the U.S. may soon have a problem if the coronavirus outbreak is not contained, he explained.

The government considered critical chokepoints after 9/11, and manufacturers of critical products like insulin were required to identify alternate methods of supply if their primary facility were to become inaccessible, Gottlieb said.

“We should… require [drug companies] to report on intermediate steps and intermediate ingredients that could also come into shortage that could create an adverse public health outcome,” Gottlieb said. “We can require companies to identify alternative supply for some of these products.”

Committee Chairman Sen. Ron Johnson (R-WI) added that in order to mitigate chokepoints in the supply chain, the federal government needs to be working on a bipartisan basis to encourage pharmaceutical manufacturing in the U.S. in a way that is profitable for drug companies. “We’ve made it risky to manufacture because the risks are high of litigation,” Johnson said.

Dr. Luciana Borio, former director for medical and biodefense preparedness at the National Security Council under the Trump administration, told Johnson that the numbers being reported in China are likely being underreported due to a lack of resources. The global numbers will rise quickly as other affected countries like Singapore, Hong Kong, and Japan continue to report.

“The features are very concerning for a pandemic and global spread,” Borio told the committee. “I think we’re going to see a lot more cases in the United States in the future.”  

Dr. Julie Gerberding, former director of the Centers for Disease Control and Prevention, advised the committee to prepare for a prolonged outbreak. “We need to be leaning into what are the next steps if we can’t contain it,” she said. The primary goal should be to create a plan for how to sustain healthcare services if the United States sees a continued outbreak, she explained. 

The next step in combatting the coronavirus would be to shift resources to the nation’s healthcare system, which the panelists agreed is not currently equipped to handle a massive influx of infectious patients seeking treatment for an illness like the coronavirus.

Gerberding described the “herky-jerky funding” of the nation’s public health agencies as a major roadblock for improvements. “When something happens… we’re very competent at making an emergency investment and stepping up in the crisis to get miraculous things accomplished, but we don’t sustain it,” she said.

The American health care model puts an emphasis on preventative measures as the best practice for preventing medical emergencies. The “reactionary funding” that infuses public health agencies with money only during national emergencies like the corona outbreak doesn’t allow the agencies to support that prevention mission, Gerberding said.

Each panelist agreed that their respective former agencies need more funding to be able to sustain the level of work required to mitigate emergency outbreaks.

The additional funding would allow agencies like the CDC and the National Institute of Health to deploy public health experts to the center of an outbreak so that containment efforts can take place while the health risk is still outside U.S. borders.

The funding would also allow agencies to teach local hospital staff in rural America how to deal with a global pandemic, something they are not currently trained to do, according to Gerberding. Sen. Jacky Rosen (D-NV) called the community hospitals “the front lines” of public health crises.

Sen. Maggie Hassan (D-NH) noted the importance of creating medical diagnostic kits to test patients for the coronavirus. She asked the panel about the FDA’s involvement in that process.

Gottlieb explained that the FDA has issued an Emergency Use Authorization for the diagnostic kits, which allows the agency to bypass regulatory requirements for drug companies developing them. Drug companies and the FDA are now working together to get the kits into the market.

The coronavirus currently has a much higher fatality rate than the seasonal flu that Americans are used to, Gottlieb said. Panelists reminded the audience that frequent handwashing is still the best method of prevention as the public health sector works to contain the outbreak.

Sen. Johnson and the committee’s ranking member, Sen. Gary Peters (D-MI) both expressed disappointment that the current heads of the CDC and the Department of Homeland Security chose not to attend this public hearing.

Sen. Johnson told the audience at adjournment that those agency heads were briefing the Senate in a closed hearing later Wednesday morning.

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