U.S. Senators Tina Smith, Tom Cotton Reintroduce Bipartisan Legislation to Boost U.S. Pharmaceutical Manufacturing

WASHINGTON, D.C. — Today, Senators Tina Smith (D-MN) and Tom Cotton (R-AR) reintroduced bipartisan legislation to reduce dependence on foreign pharmaceutical manufacturing and boost production in the U.S.  

The pandemic exposed our nation’s dependence on other countries for essential prescription drugs. Seventy-seven percent of key pharmaceutical ingredients come from overseas, including from China, threatening the security of the supply chain and leading to shortages of essential prescription drugs.

The American Made Pharmaceuticals Act would reduce our dependence on foreign countries for pharmaceuticals by boosting production here at home. The legislation would create federal incentives to onshore manufacturing of essential medicine, while taking steps to shore up links in the supply chain.

“We know that depending on foreign countries for key resources – whether it’s oil or medicine – leaves us vulnerable to global supply chain shocks and shortages,” said Sen. Smith. “This bipartisan legislation would reduce our dependence on foreign pharmaceutical manufacturing and help boost production here at home. I look forward to getting this bill across the finish line so we can relieve prescription drug shortages and build more resilient supply chains.”

“The Chinese Communist Party threatened to cut off America’s access to vital drugs during the pandemic,” said Sen. Cotton. “It’s time to bolster onshore manufacturing of pharmaceuticals to ensure Americans never have to rely on China for lifesaving medicine.”

“Amneal applauds Senators Smith and Cotton on their targeted approach to increase pharmaceutical manufacturing here in the United States,” said Chirag Patel, President & Co-CEO of Amneal Pharmaceuticals.  “Ensuring that an adequate supply of medicines is manufactured in the U.S. continues to be a priority for Amneal.  We firmly believe that the pathway to a resilient pharmaceutical supply chain and eliminating drug shortages lies within our nation. Amneal’s commitment to reshoring underscores not only our dedication to American workers but also our resolve to prioritize and protect the health of every American.”

“Ensuring our nation’s independence on manufacturing and producing cost-effective, lifesaving medicines is paramount. That is why Coherus BioSciences fully supports U.S. Senators Tina Smith and Tom Cotton introducing the American Made Pharmaceuticals Act,” said Denny Lanfear, Chairman and CEO of Coherus BioSciences.  “As an American biotech company, Coherus is proud to partner for production, manufacturing, and distribution here in the United States. The passage of this bill will ensure that American companies can continue to invest in our employees and partners here, in the United States, so that we can bring safe, quality, and lifesaving medicines to millions of Americans.”

“The SAMS coalition fully endorses U.S. Senators Tina Smith and Tom Cotton for introducing the American Made Pharmaceuticals Act,” said David Sanders, Executive Director of Securing America’s Medicine and Supply (SAMS). “They’re leading by example in a bipartisan fashion to address real concerns our country is currently facing regarding domestic drug shortages. With rising international conflicts, and shortages of critical medicines such as standard of care cancer treatments, it’s absolutely crucial that our nation is prepared to serve the healthcare needs of all Americans, and this bill does just that by rewarding companies which produce and manufacture quality medicines here at home.”

Specifically, The American Made Pharmaceuticals Act would:

  • Establish a demonstration program at CMS to test providing preferential treatment for U.S. manufactured generics, biosimilars, and critical medicines under the Medicare, Medicaid, and CHIP programs in at least 8 states for at least 7 years.
  • Require the Department of Health and Human Services (HHS) to consider mechanisms to give U.S. manufactured drugs and biosimilars preference, including preferential treatment on a formulary, lower cost-sharing, rebate waivers under the Medicaid program, utilization of the Medicare Star Rating system, or bonus payments to providers of services and suppliers.
  • Require eligible pharmaceutical companies to provide transparency on manufacturing locations, maintain appropriate inventory and emergency reserves, and have an action plan for when links in the supply chain break down.
  • Direct the Secretary of Health and Human Services to submit an annual report to Congress on activities under the program as well as recommendations for any legislative and administrative actions deemed appropriate.