Washington, D.C.—At a Senate Health Committee hearing on the coronavirus this morning, U.S. Senator Susan Collins urged top officials from U.S. health agencies to take action to prevent drug shortages and protect Americans, particularly seniors in nursing homes and assisted living facilities, from the spread of the virus.
A significant portion of active pharmaceutical ingredients (API) are produced in China, making medications vulnerable to supply chain disruptions. Last week, the FDA announced the first coronavirus-related drug shortage in the U.S. Senator Collins authored the Mitigating Emergency Drug Shortages (MEDS) Act, which would enhance reporting requirements of potential drug shortages and help increase the supplies of vital drugs. Senator Collins asked Dr. Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration, whether this legislation would assist his agency as it responds to the current public health threat.
“The FDA has testified previously that only 28% of the manufacturing facilities making APIs to supply the U.S. market are located in our country. By contrast the remaining 72% of API manufacturers supplying our American market are overseas and 13% are in China,” said Senator Collins. “[The MEDS Act] contains new reporting requirements that would help FDA gain far greater visibility into the drug supply chain, including where certain critical drugs are manufactured, the source of active pharmaceutical ingredients, and manufacturing contingency and redundancy plans. Given the problems that we’re already seeing, do you believe that the concepts included in our legislation…would be helpful?”
“Thank you for your question, and we really appreciate your leadership on this issue,” Dr. Hahn responded. “The agency totally shares your goal with mitigating and increasing redundancy for manufacturing, particularly in the area of advanced manufacturing. We look forward to working with you on that.”
Senator Collins, the Chairman of the Aging Committee, also raised the issue of the coronavirus outbreak at a nursing home in the State of Washington, which has caused the deaths of multiple residents. She asked Dr. Anne Schuchat, the Principal Deputy Director of the Centers for Disease Control and Prevention (CDC), about their response.
The estimate I’ve seen is that 15% of patients 80 and older do not survive compared to just over 2% in the general population of patients. In addition to the figure from China, there is the tragic situation evolving in Washington State regarding the spread of the virus in a long-term care facility. This is of particular interest to me, because I represent the state that is the oldest in the nation by median age, and I also chair the Senate Aging Committee,” said Senator Collins. “[W]hat is the Administration doing, and what is the CDC doing in all aspects of response to ensure that we have the best practices in assisted living facilities and nursing homes or long-term care facilities?”
“Infection control is always an issue in the different levels of health care, and the elderly are very vulnerable to respiratory viruses,” Dr. Schuchat replied. “We see that same differentiation in mortality with influenza as well, that the elderly are very vulnerable.
Dr. Schuchat also told Senator Collins that she was in close contact with the Centers for Medicare and Medicaid Services, which is using its field staff to make sure that providers around the country are using best practices to fight the coronavirus.
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