The PREPARE Act Would Establish a Domestic Reserve of Active Pharmaceutical Ingredients for Essential Medicines; Ensure Americans Have Sufficient Supply for Future Emergencies
WASHINGTON, DC – Today, U.S. Senators Sherrod Brown (D-OH) and Bill Cassidy, M.D. (R-LA) announced their bipartisan Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act of 2021. The PREPARE Act, introduced yesterday, would create an emergency supply of key ingredients used in essential generic medicines and incentivize domestic manufacturing of these ingredients to build a more resilient domestic supply chain.
“The pandemic has revealed gaping holes and vulnerabilities in our supply chains – perhaps none more critical than our medical supply chain,” said Brown. “This bipartisan legislation will help build emergency capacity for essential medicines here in the U.S. There is no reason we should be relying on countries like China or India for nearly 90 percent of these critical pharmaceutical ingredients, when we have talented scientists and manufacturers right here.”
“COVID reminded us that we are too reliant on foreign countries for generic drugs and pharmaceutical products. This bill brings enough production back to the U.S. so America is better prepared,” said Cassidy.
Right now, the United States depends on other countries for a range of pharmaceutical products, including many active pharmaceutical ingredients (APIs) that are essential to create generic prescription drugs. Generic drugs make up 90 percent of all prescriptions filled in the United States, and about 87 percent of API facilities for generic medicines are located overseas.
The PREPARE Act would require the Secretary of Health and Human Services to maintain a list of essential generic medicines and build out a domestic supply of the API necessary for those medicines, with a preference for domestic manufacturers and contractors. The legislation will help build emergency capacity for essential API here in the U.S. and support a more resilient domestic supply chain. Specifically, the PREPARE Act would:
- Build on an Executive Order issued in August 2020 to require the HHS Secretary to establish and make public a list of essential generic medicines that are medically necessary to have available at all times
- Establish a new position within HHS – the Director of the Strategic Active Pharmaceutical Ingredients Reserve – responsible for managing a domestic reserve of essential API
- Establish a new federal entity to identify, purchase, track, transport, manage, store, and convert an emergency supply of active pharmaceutical ingredients for essential generic medicines
- Strengthen U.S. domestic capacity for API production, storage, and conversion into finished dosage form
The PREPARE Act has been endorsed by organizations representing a variety of roles across the health care continuum, including the Cleveland Clinic, Civica Inc, The Mark Cuban Cost Plus Drug Company, Phlow, Virginia Commonwealth University and Xellia Pharmaceuticals.
“This legislation would remove caregivers’ concerns about not having sufficient supplies so they can focus on patient care,” said Chief Pharmacy Officer Samuel Calabrese of the Cleveland Clinic. “When we know we have access to APIs we can ensure that we have a supply for our patients and their needs.”
Dr. Stephen Davis, the Chief Operations Officer of Cincinnati Children’s Hospital echoed Calabrese’s comments, saying, “The ability to stockpile the building block ingredients of pharmaceutical agents provides distinct advantages including much less risk of medications expiring before they are used, shortening the supply chain and increasing the flexibility of what concentrations of a medication are made based on actual needs. This is a significant step forward in reducing drug shortages in times of crisis.”
An identical bill will be introduced in the U.S. House of Representatives by Rep. Abigail Spanberger (D-VA) and Rep. David McKinley (R-WV).
“If we’ve learned one thing from the pandemic, it’s that relying on foreign supply chains for vital and lifesaving products is a bad idea. The pharmaceutical industry, and especially active pharmaceutical ingredients, provide a glaring example of our vulnerability,” said McKinley. “Around 87 percent of API facilities for generic drugs are located overseas. America needs to develop a resilient domestic supply of API that can avoid shortages of essential medicines during an emergency. Our bipartisan bill would be an important step to building this capacity.”
“Investments in advanced manufacturing techniques of essential medicines can improve our resiliency in the face of public health emergencies, increase American manufacturing capacity, and prevent shortages of lifesaving medicines — but we need to secure the infrastructure necessary to secure, store, and distribute the key ingredients used to make these drugs,” said Spanberger. “Central Virginia is home to a growing and dynamic biopharmaceutical industry — and this legislation would help secure our domestic supply chains, create new jobs, and keep our nation competitive. I look forward to introducing the House version of this bipartisan legislation soon, and I would like to thank Senators Brown and Cassidy for their leadership on this legislation in the U.S. Senate.”