WASHINGTON, DC – U.S. Senator Gary Peters, Ranking Member of the Homeland Security and Governmental Affairs Committee, introduced two bills to address vulnerabilities in the medical supply chain and increase capacity for domestic advanced manufacturing of critical drugs and medical devices in the United States. America’s pandemic response efforts have been hindered by shortages of critical drugs and medical supplies, such as personal protective equipment – highlighting the dangers of America’s reliance on foreign producers of these vital resources. In a 2019 report, Peters raised concerns and identified recommendations to address the risks posed by America’s overreliance on foreign sources of key medications and supplies. In the report, Peters called for urgent action to bring critical manufacturing back to the United States, which would encourage domestic production of these key supplies.
“For decades, the United States has failed to adequately take stock of its growing dependence on foreign sources of critical drugs and medical supplies. And now Michiganders and people across the country are suffering the consequences and struggling to obtain the personal protective equipment, ventilators, testing kits and medicine needed to respond to the Coronavirus pandemic,” said Peters. “It’s long past time the federal government acted to address these mistakes, which is why I’m proud to introduce these vital bills to strengthen visibility into our supply chains and bring manufacturing for critical drugs back where it belongs – the United States and Michigan.”
Peters’ 2019 report, A Price Too High: Cost, Supply, and Security Threats to Affordable Prescription Drugs, identified numerous economic, public health, and national security threats stemming from growing prescription and hospital-administered drug shortages in the United States and the country’s overdependence on foreign pharmaceutical and medical supply chains, particularly in China and India.
Peters’ legislation follows recommendations from his report to identify the scope of the United States’ reliance on foreign drug and medical supply manufacturers and encourage investments in domestic manufacturing of critical medications and supplies. The Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, would expand reporting requirements for manufacturers and require quarterly disclosures to the Food and Drug Administration (FDA) on critical manufacturing data such as which medications and what in amount – including active pharmaceutical ingredients – are produced domestically and abroad. Manufacturers would also be required to report any increased demand or export restriction to proactively address potential shortages. The FDA would be required to share critical manufacturing data with the Defense Department (DOD) and the Assistant Secretary for Preparedness and Response (ASPR) – the office charged with protecting Americans from health security threats, including pandemics.
The Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act, would help reduce U.S. reliance on foreign sources for critical drugs and medical supplies and ramp up American manufacturing capacity. The bill would establish a Center for Domestic Advanced Manufacturing of Critical Drugs and Devices charged with facilitating investments in advanced manufacturing capabilities for critical drugs and devices throughout the United States. The Center, located within the Department of Health and Human Services (HHS), would:
- assess, in coordination with the Department of Homeland Security and DOD, supply chain vulnerabilities for critical drugs and devices;
- award funding to qualified manufacturers to invest in advanced manufacturing and increased domestic production of critical drugs and medical supplies in the U.S.; and
- encourage federal agencies to enter into long-term, high-volume contracts for these products.
Below are statements in support of Senator Peters’ efforts:
"Michigan's health professionals have been on the front lines of the COVID-19 pandemic, putting themselves in harm’s way to protect public health,” said Brian Peters, Chief Executive Officer of the Michigan Health & Hospital Association. “For many years, our health care workers have also been challenged by shortages of critical drugs and medical supplies as they work to ensure patient safety and high-quality care. We applaud Senator Peters’ foresight on this crucial issue. The MHA supports his efforts to address vulnerabilities in the medical supply chain and increase investments to bring critical manufacturing capabilities back to the United States."
“ASHP applauds Senator Peters’ leadership in addressing the critical issue of drug supply chain security by introducing these bills,” said Paul Abramowitz, Chief Executive Officer of the American Society of Health-System Pharmacists. “Mitigating drug shortages has been a longstanding priority for health system pharmacists. We believe this legislation is an important step in working to ensure patients have reliable access to safe and effective medications when they need them.”
“As the global COVID-19 pandemic has clearly demonstrated, gaps in the medical supply chain can pose serious threats to the health and wellbeing of the American people,” said ASA President Mary Dale Peterson, M.D., MSHCA, FACHE, FASA. “More must be done to identify these vulnerabilities before crises strike, or risk widespread disruptions that impact our ability to care for our patients. That’s why the American Society of Anesthesiologists is proud to support Senator Peters’ Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act which will help us better understand the extent of America’s dependence on foreign manufacturers and shore up domestic supply chains.”