Bipartisan legislators seek emergency reserve of key pharmaceutical ingredients through PREPARE Act

In order to avoid some of the worst issues experienced by supply chains at the height of the COVID-19 pandemic, U.S. Reps. Abigail Spanberger (D-VA) and Don Bacon (R-NE) recently introduced a bill to create an emergency reserve of active pharmaceutical ingredients while incentivizing domestic manufacturing.

The Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act would establish a new national stockpile of key ingredients and push to buck dependency on foreign producers for them. The bill’s authors pointed out that generic drugs make up approximately 91 percent of all prescriptions filled in the United States, but about 87 percent of active pharmaceutical ingredient facilities for them are located outside the United States.

China and India control a large chunk of that supply chain, and in recent years, the relationship between the U.S. and China has soured significantly.

“Increasing the supply of critical pharmaceutical ingredients that are made in the United States and strengthening our domestic supply chains are smart investments,” Spanberger said. “By increasing our production of these ingredients at home, we can reduce our reliance on foreign manufacturing of the medications Americans rely on. 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.”

If adopted, the bill would require the Secretary of the U.S. Department of Health and Human Services (HHS) to create a list of essential generic medicines for consultation by the general public. It would also establish a national stockpile of API for these medicines to boost U.S. emergency preparedness capacity, as well as a plan to store, track, test and convert API within that reserve into finished dosage form while improving U.S. capacity for their production. It would also make bureaucratic changes to help manufacturers ramp up production quicker during emergencies.

“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,” Bacon said.

This is not the first time the bill has been proposed. Spanberger first introduced the legislation in 2021. This time around, it’s also backed by various health care organizations such as the Mark Cuban Cost Plus Drug Company, Civica Inc., Phlow, VCU, SK pharmteco and Xellia Pharmaceuticals.