McKinley and Spanberger Introduce Legislation to Protect America’s Pharmaceutical Supply Chain

This week, Congressman David B. McKinley, P.E. (R-WV) and Congresswoman Abigail Spanberger (D-VA) introduced bipartisan legislation to create an emergency supply of ingredients used in vital generic medicines and incentivize domestic manufacturing of these ingredients.

The United States currently depends on other countries for a range of pharmaceutical products, including many active pharmaceutical ingredients (APIs) that are essential for the creation of generic prescription drugs. Generic drugs make up nearly 90 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.

The Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE Act) strengthens America’s domestic pharmaceutical supply chain. The legislation would require the U.S. Department of Health and Human Services (HHS) to compile a list of essential generic medicines and build out a domestic supply of the API necessary to produce those medicines, with a preference for manufacturers within the United States.

“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.”  

“In recent years, the greater Richmond region has emerged as a national leader in biopharmaceutical research and production. That’s why I was so proud to stand at VCU alongside leaders in the fields of business, higher education, medicine, and research who recognize the critical importance of this industry to the health of our neighbors and the long-term success of our economy. Smart investments in these advanced manufacturing techniques will improve our resiliency in the face of public health emergencies, increase domestic manufacturing capacity, and prevent shortages of lifesaving medicines. However, we need to build the infrastructure necessary to secure, store, and distribute the key ingredients used to make these drugs,” said Spanberger. “Our PREPARE Act would help secure our domestic supply chains, create new jobs, and keep our nation competitive — and it would make sure Central Virginia continues to lead the way through its growing and dynamic biopharmaceutical industry. I want to thank Congressman McKinley for his partnership on this issue, and I would like to thank Senators Brown and Cassidy for their leadership on this legislation in the U.S. Senate.”

Senators Sherrod Brown (D-OH) and Bill Cassidy (R-LA) are leading identical legislation in the U.S. Senate.

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.

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

Click here for a one-pager and section-by-section summary on the PREPARE Act. Click here for the full bill text.

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