U.S. Senator Bob Menendez, ranking member of the Senate Foreign Relations Committee and a senior member of the Senate Finance Committee that sets national health policy, and U.S. Rep. Bill Pascrell, Jr. (N.J.-09) wrote to Commissioner Steven Hahn of the Food and Drug Administration (FDA) requesting information and details on the federal government’s plan to preserve the medical supply chain in light of the Coronavirus (Covid-19) outbreak. In 2018, the United States imported more than $13 billion of drugs, devices and food from China.
“As the outbreak continues, the risk to the medical supply chain is potentially calamitous due to global dependence on Chinese manufacturing,” the lawmakers wrote to FDA Commissioner Steven Hahn, “As such, we request information on the FDA’s plan to address the safety and security of our supply chain.”
China is the world’s largest producer of active pharmaceutical ingredients (APIs) and the U.S. relies heavily on drugs that are sourced from China or include APIs from China. While the FDA has indicated it is taking proactive measures to address any disturbances to the drug supply chain to China, the members question if they are sufficient in light of the epidemic’s growth in recent weeks, citing Beijing’s already overtaxed regulatory system and potential inspector shortage.
The World Health Organization (WHO), which declared the outbreak a Public Health Emergency of International Concern, has raised concerns over the secureness of the medical supply chain, noting that stockpiles have depleted to a four-to-six month backlog.
“These levels are insufficient to meet the current WHO’s needs and we remain concerned about further deterioration. Furthermore, the demand of PPE has risen 100 times since the COVID-19 outbreak began,” the lawmakers wrote. “This is relevant because China manufactures most of the world’s masks, gowns, and respirators, which are essential tools for U.S. hospitals during an infectious disease outbreak. As the outbreak of COVID-19 intensifies, we are concerned that the demand will outpace the supply of PPE.”
WHO has reported that there are now over 79,000 cases of coronavirus worldwide, with 53 confirmed cases in the U.S.
“We hope that the FDA is doing everything possible to make modifications to protect the drug and PPE supply chain and expand efforts at transparency. Keeping the public updated and informed at all times is essential. We hope the FDA will look to Congress as a partner in ensuring our common goal of eliminating negative impacts to U.S. public health,” the lawmakers concluded.
Sen. Menendez has been leading efforts in Congress to ensure New Jersey has the resources to combat the coronavirus outbreak.