Warner: U.S. too dependent on foreign-made pharmaceuticals
The coronavirus outbreak has brought into the forefront the dangerous consequences of this dependence on the wellbeing of Americans and on U.S. national security.
In a letter to the U.S. Department of Health and Human Services, Sen. Warner requested that HHS develop a short-term strategy to ensure Americans have access to necessary medical products, and a long-term plan to reduce reliance on foreign supply chains.
“For millions of Americans, access to their drug supply can mean life or death. Yet increasingly, the United States produces very few of these products domestically,” Sen. Warner wrote in the letter. “For example, the active ingredients for medicines treating breast and lung cancers and the antibiotic Vancomycin are made almost exclusively in China. China is also the largest supplier of medical devices, such as MRI equipment, surgical gowns and other equipment that measures oxygen levels in the blood.”
In the letter, Sen. Warner cited the testimony of Janet Woodcock, the director of the Center for Drug Evaluation and Research who testified before the House Committee on Energy and Commerce about the growing U.S. reliance on foreign sources of active pharmaceutical ingredients (APIs).
According to Woodcock, only 28 percent of manufacturing facilities making APIs for the U.S. market are in the United States, and three of the “essential medicines” identified by the World Health Organizations have API manufacturers that are based only in China.
Additionally, Sen. Warner requested a briefing and a written response to the following questions:
- What actions has HHS taken to address the dependence on Chinese or other foreign manufacturers of drugs, APIs, or other pharmaceutical products and medical supplies and equipment since the outbreak of the COVID-19?
- What is your strategy to ensure that Americans get the pharmaceuticals they need if significant shortages occur?
- As the coronavirus continues to spread, what actions has HHS taken to ensure that patients can still access the drugs they need without access to drug components manufactured overseas?
- What is your analysis of what drugs or ingredients cannot be made without supplies from China and other foreign countries?
- What is your plan to ensure that medical facilities, medical personnel and first responders have a reserve of necessary medical supplies and equipment as they continue to be on the front lines of efforts to prevent the spread of COVID-19?
- Congress recently passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, which includes more than $2 billion for the Biomedical Advanced Research and Development Authority (BARDA) to invest in platform-based technologies with U.S-based manufacturing for vaccines and therapeutics. How will HHS ensure these funds effectively reduce our short and long-term reliance on foreign manufacturers of drugs, APIs, or other pharmaceutical products and medical supplies and equipment?