The “PREPARE Act” Would Create a National Stockpile of Active Pharmaceutical Ingredients to Strengthen Domestic Manufacturing of Generic Medicines

WASHINGTON, D.C. — U.S. Representatives Abigail Spanberger (D-VA-07) and Don Bacon (R-NE-02) reintroduced bipartisan legislation to create an emergency supply of key ingredients used in essential generic medicines and incentivize domestic manufacturing of these ingredients.

The United States currently depends on foreign producers for a range of pharmaceutical products — including many active pharmaceutical ingredients (APIs) that are essential components of generic prescription drugs. Generic drugs make up approximately 91 percent of all prescriptions filled in the United States — but about 87 percent of API facilities for generic medicines are located outside the United States, with China and India controlling a substantial portion of the supply chain.

Spanberger and Bacon’s Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act would help strengthen America’s domestic pharmaceutical supply chain. Specifically, their legislation would require the Secretary of the U.S. Department of Health and Human Services (HHS) to maintain a list of essential generic medicines and create an emergency supply of the API necessary for those medicines — with a preference for American manufacturers and contractors.

“Increasing the supply of critical pharmaceutical ingredients that are made in the United States and strengthening our domestic supply chains are smart investments. By increasing our production of these ingredients at home, we can reduce our reliance on foreign manufacturing of the medications Americans rely on,” said Spanberger. “The United States should not have to depend on our adversaries — like the Chinese Community Party — for key ingredients in U.S. drugs. Our bipartisan legislation would help prevent shortages of critical medications, create new jobs, and keep our nation competitive — and it would make sure Virginia’s dynamic biopharmaceutical industry continues to lead the way.”

“Ensuring the national security of the United States is not just about military strength, but about emergency preparedness including maintaining a domestic supply of active pharmaceutical ingredients needed to manufacture generic medicines,” said Bacon. “Our legislation will create a national stockpile and opportunities to grow jobs and investments in American medicine manufacturers, instead of relying on those who are not working in our best interests, such as the Chinese Community Party.”

The PREPARE Act would improve the resiliency of the U.S. pharmaceutical supply chain and fight shortages of essential drugs by:

• Requiring the Secretary of the U.S. Department of Health and Human Services to establish and make public a list of essential generic medicines that are medically necessary to have available at all times;

• Creating a national stockpile of API for these essential generic medicines to further bolster U.S. emergency preparedness capacity;

• Establishing a plan to store, track, test, and convert API stored in the reserve into finished dosage form and strengthen U.S. capacity for API production; and

• Cutting red tape that could prevent a manufacturer from ramping up production in an emergency.

Spanberger originally introduced the bipartisan legislation in September 2021.

The PREPARE Act has been endorsed by organizations representing a variety of roles across the health care continuum — including the Mark Cuban Cost Plus Drug Company, Civica Inc., Phlow, VCU, SK pharmteco, and Xellia Pharmaceuticals.

Click here for the full bill text.

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