Healthcare Committee Chairwoman: Rosemary Gibson, author of China Rx
The Coalition for a Prosperous America advocates for domestic manufacturing of essential generic drugs, personal protective equipment (PPE), and other critical health care products because it is vital for our country's health security and national security.
COVID-19 showed that in a pandemic, the United States cannot depend on other countries for essential medicines and other medical supplies. Many countries banned exports of them to assure they had enough for their own people.
It is a national security imperative that our country is not dependent on unfriendly nations. At the height of the pandemic, the Chinese Communist Party threatened to withhold essential drugs from America. This threat reveals the inclination by some nations to use medicines as an economic and geopolitical weapon. We must have the capability to manufacture medicines and medical supplies necessary for the country's public health and survival.
Five Pillars of Domestic Manufacturing to Safeguard Essential Medicines and Supplies
i. Essential Generic Drugs and PPE Should Be Manufactured in the United States
The Department of Health and Human Services, (HHS), the Department of Defense (DoD), and the Veterans Administration should identify and maintain a list of essential medicines and supplies necessary for preparedness and the functioning of civilian and military health care systems. The risks of dependence on sole suppliers, fragile suppliers and unfriendly countries should be assessed, and these risks should be factored in the determination of products that are essential for manufacturing in the United States.
ii. "Buy American" Should be Top Priority for Federal Government Procurement
The U.S. government should use Buy American provisions to ensure that the Department of Defense, Veterans Administration, and other federal agencies buy essential medicines, equipment, and supplies fully made in the United States. The men and women who serve in the military and all Americans should not be vulnerable to unsafe products sourced from adversary nations where the FDA has ceased inspections of manufacturing plants since COVID-19. Buy American provisions will give domestic manufacturers reliable, long-term customers, and will be a stepping stone to rebuilding the nation's industrial base.
iii. Advanced Manufacturing is More Efficient and Cost-Saving
Advanced manufacturing can play a vital role in enabling the United States rebuild generic manufacturing capability. The United States government should establish an office in the Department of Health and Human Services dedicated to “Domestic Advanced Manufacturing of Critical Drugs and Devices." Such an office would have jurisdiction to prioritize critical drugs needed to be fully manufactured domestically. The new office would also oversee grants, loans, financial incentives, and purchase orders to support U.S. manufacturers.
This office would be subject to annual appropriations and would operate under strict national security provisions to prohibit foreign companies from capitalizing on taxpayer-funded investments. The office would also have to ensure those participating are prohibited from selling their operations to foreign actors during their term of awarded contract or financial assistance and beyond.
iv. Simplified Approval Process for Domestic Manufacturing of Generic Medicines
The U.S. government should carry out a comprehensive review of all barriers for generic entry to market and expand on past studies. To increase the supply of US-manufactured generics, it must be simpler for new domestic manufacturers to enter the market while preserving safety standards. The review will provide a clear path to remove regulatory hurdles or procedural roadblocks used by government agencies or branded product manufacturers to slow generic entry to market, such as Risk Evaluation and Mitigation Strategy (REMS) and other restricted access programs that block new domestic entrants to the market. Lastly, duplicative regulations at various agencies should be addressed and streamlined to promote safe medicines for Americans without cumbersome red tape.
v. Phase Out Procurement of Essential Medicines, PPE, and Other Medical Supplies Made in China
As soon as alternative non-China sources are available, the United States government should ban essential medicines, PPE, and other medical supplies made in China and those made with material sourced from China.
These are the five pillars we believe are important to assure the nation's health security and national security.
Many legislative efforts on “reshoring” or “safeguarding” our medicines, PPE, and other supplies have been introduced but very few move the needle. We believe a bill that addresses all these pillars will rebuild our domestic industrial base and assure an unfettered supply of high-quality medicines and supplies for the American people for generations to come.