The Senate Finance Committee questioned FDA officials about US policies on hydroxychloroquine, the World Health Organization, and supply chain security

By June 5, 2020

The coronavirus has killed over 108,000 people, and infected millions, in the US alone. As some areas of the country begin to lift infection control precautions, it is critical for the federal response to the COVID-19 pandemic to improve. An important part of this process is Congressional oversight of the Administration’s response to COVID-19, and during Tuesday’s Senate Finance Committee hearing, Members pressed Food and Drug Administration (FDA) officials on decision-making around the potential COVID-19 treatment hydroxychloroquine, the Administration’s commitment to withdraw from the World Health Organization (WHO), and reliance on China and other foreign countries for drug manufacturing.

Policy on hydroxychloroquine as a treatment for COVID-19

Early in the pandemic, anecdotal reports of COVID-19 patients in China and France who seemed to improve when given hydroxychloroquine, combined with laboratory findings of a possible antiviral effect, raised hopes that hydroxychloroquine, and a closely related drug chloroquine, could serve as treatments for the coronavirus. The drugs had been FDA-approved for the safe and effective treatment of malaria, lupus, and rheumatoid arthritis for many years. President Trump began publicly promoting chloroquine as a potential COVID-19 treatment, and later at the end of March, FDA granted an emergency use authorization (EUA) for both chloroquine and hydroxychloroquine to be used for COVID-19 patients.

The first study describing a large, controlled clinical trial of hydroxychloroquine for COVID-19 was released this week. It was found that people, such as healthcare workers, who experienced high risk exposures to the coronavirus, and who were then given hydroxychloroquine and monitored, developed COVID-19 just like those who experienced high-risk exposures and who were given placebo. Furthermore, the study found that hydroxychloroquine did not impact the severity of illness for these individuals. The question of whether hydroxychloroquine can prevent coronavirus infection if people take it before they are exposed to sick patients is under study in other clinical trials.

During Tuesday’s hearing, Senator Ron Wyden (D, OR), the ranking member of the Committee, said he believed FDA gave in to political pressure when it approved the EUA for hydroxychloroquine. Senator Wyden noted that the EUA led to the production of “tens of millions of pills, including some…manufactured inside facilities in Pakistan and India that have either failed FDA’s inspection or never been inspected by the FDA at all.”

The Government Accountability Office is evaluating the FDA process that resulted in the EUA for hydroxychloroquine and chloroquine to learn if the EUA was purely based on the FDA’s science-based best practices.

Plans to terminate relationship with the World Health Organization

Last Friday, President Trump announced his Administration’s intention to withdraw the US from WHO. In the global fight against disease, WHO’s roles in providing assistance, setting health standards, and collecting data are critical. Considering WHO convenes international partners to support the development of COVID-19 drugs, vaccines, and other measures to curb spread, a US withdrawal will weaken our ability to fight the pandemic. Furthermore, US absence from WHO would allow nations like China, which stalled its delivery of essential COVID-19 information to WHO, to have even more influence on the global stage.

When asked about how the US plans to address global health needs, such as the COVID-19 pandemic, or Ebola in Congo, or polio in Yemen, without being a member of WHO, the FDA’s associate commissioner for global policy and strategy Mark Abdoo responded that he had “not been privy to those conversations” and referred the Committee to the National Security Council or the Presidential spokesperson.

Meanwhile, Chinese President Xi Jinping pledged to contribute $2 billion to WHO over the next two years to mitigate the COVID-19 pandemic, as well as share any coronavirus vaccine developed in China with the world. China’s government or Chinese companies have developed five of the ten coronavirus vaccine candidates currently being tested in clinical trials around the globe.

Reliance on foreign drug manufacturing

Most manufacturing of finished drugs and active pharmaceutical ingredients is done outside the US. Throughout the pandemic, there have been shortages of certain drugs. Many members of the Committee, including Senator Pat Toomey (R, PA), asked about the security of the US supply chain for medicines, concerned that countries such as China could withhold drugs or ingredients, or that future global health emergencies could leave the US vulnerable to being without needed drugs.

FDA officials assured the Committee that the US drug supply is safe and supply chains are secure, and that, to their knowledge, no countries had held back medicines. They attributed the limited drug shortages in the US mainly to a sudden surge in demand for drugs as well as domestic distribution issues. They also advised that the US bolster its domestic drug manufacturing capacity now since the US is bound to face future pandemics. Drug companies could move more production back to the US by implementing advanced manufacturing techniques that allow for more rapid production of drugs, while at the same time reducing environmental impacts.

For the full video of the hearing, click here.