Spanberger introduces bill to create emergency reserve of pharmaceutical ingredients

Abigail Spanberger
Abigail Spanberger

Congresswoman Abigail Spanberger (D-VA-07) has introduced legislation that would 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 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 approximately 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.

Spanberger’s Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE Act) would help create and support thousands of new jobs within the Richmond area’s burgeoning biopharmaceutical sector and help strengthen America’s domestic pharmaceutical supply chain.

Specifically, her legislation would require the Secretary of the U.S. Department 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 American manufacturers and contractors.

During the announcement, Spanberger outlined the need to introduce the bipartisan PREPARE Act, opportunities for the biopharmaceutical industry in Greater Richmond, and the importance of preventing shortages of critical medicines.

“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 today 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.”

Spanberger co-led the introduction of this bipartisan bill with Congressman David B. McKinley (R-WV-01).

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

“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.”

Spanberger was joined by VCU President Michael Rao, Ph.D, VCU Board of Visitors Rector Ben Dendy, Medicines for All Institute Co-Founder Dr. B. Frank Gupton, VCU Provost and Senior Vice President for Academic Affairs Fotis Sotiropoulos, and ChamberRVA President and CEO Brian Anderson.

“We thank Congresswoman Spanberger for her leadership on this important issue,” said Michael Rao, Ph.D., President, Virginia Commonwealth University. “The PREPARE Act is an important step forward for our national security and our economy.”

“Today, nearly all of the active ingredients for Americans’ essential medications come from overseas, leaving us vulnerable to shortages. The efforts that Congresswoman Spanberger and her team have focused on to address this issue is a major milestone towards making our country self-sufficient with regards to access to healthcare,” said B. Frank Gupton, Ph.D., Floyd D.Gottwald, Jr. Chair in Pharmaceutical Engineering; Chair, Professor, Department of Chemical and Life Science Engineering, Virginia Commonwealth University; Founder & CEO, Medicines for All Institute; Co-Founder, Phlow Corp.

“The pandemic has shown us how vulnerable our supply is, especially for critically needed health and medical supplies. Policies and legislation to incentivize domestically produced medicine is critical to protecting our country,” said Brian Anderson, President & CEO, ChamberRVA.

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 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, VCU, 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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