Senator Collins urged health officials to bring pharmaceutical manufacturing to U.S. soil
Washington, D.C. — At a U.S. Senate Health Committee hearing today titled, “COVID: An Update on the Federal Response,” U.S. Senator Susan Collins, a member of the Committee, questioned health officials about the federal government’s ongoing efforts to address the COVID-19 pandemic.
As vaccines, treatments, and guidelines are developed to fight the COVID-19 pandemic, the American people need confidence that the FDA, CDC, and NIH will abide by their gold standard rigorous protocols and procedures to preserve scientific integrity. Nevertheless, just last week, Department of Health and Human Services (HHS) Secretary Alex Azar barred the nation’s health agencies from signing new rules themselves regarding medicines or medical devices, as they normally would do.
“Such a major change at this critical time could delay progress and cause the American people to doubt whether they can trust that proper protocols are being followed,” said Senator Collins. “Could you explain why these changes are taking place, and whether they could affect new developments in medical countermeasures for COVID-19?”
“I do not believe that this will interrupt the process. You have my commitment that I will provide the best public health advice to the Secretary [of HHS] on all these matters,” replied ADM Brett Giroir, MD, Assistant Secretary for Health at HHS.
During the hearing, Senator Collins highlighted the problem of many medications’ active pharmaceutical ingredients (APIs) being manufactured overseas, creating vulnerabilities in the supply chain.
“72 percent of API manufacturing facilities are located overseas in countries like China and India. India put an export ban on some 26 APIs. We know that China hoarded PPE that our country needed,” said Senator Collins. “Are we making any progress in ensuring that the APIs that may be critical in therapeutics for treating people with the coronavirus, or in the ultimate vaccine, are manufactured right here in the United States, and not in China, or India, or somewhere else?”
“We have seen situations where the lack of redundancy in our supply chain, the lack of domestic manufacturing, has led to shortages here at home. So, we have been very active and believe we are making progress with respect to what we’re calling ‘advanced manufacturing,’” replied Dr. Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration. “With respect to the issue of medications, for example in PPE, I know that the White House Task Force has been particularly focused through FEMA, and now HHS, on making sure we build up our domestic capacity... It remains a top priority for the Food and Drug Administration. Our role in this will be to help to create whatever regulatory pathway we can so that we can facilitate advanced manufacturing that’s domestic.”
Senator Collins authored the Mitigating Emergency Drug Shortages (MEDS) Act with Senator Tina Smith (D-MN) to speed up approval of drugs in shortage, include greater reporting requirements on sources of APIs, and establish redundancy plans in the case of drug shortages. Components of this bill were included as part of the Phase 3 coronavirus emergency response package that was signed into law on March 27, 2020.
At today’s hearing, the public health leaders also provided an update on how agencies within HHS are working to assist states and communities with reopening by supporting testing; speeding the research, development, and manufacturing of new tests, treatments, and vaccines; and providing public health guidance and other support to states.