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Mullin, Smith, Cotton, Craig Introduce Bipartisan Legislation to Boost U.S. Pharmaceutical Manufacturing

Congressman Markwayne Mullin (OK-02), along with U.S. Senators Tina Smith (D-MN), Tom Cotton (R-AR), and Rep. Angie Craig (MN-02), recently introduced bipartisan legislation to reduce dependence on foreign pharmaceutical manufacturing and boost production in the U.S.    

The pandemic has exposed our nation’s dependence on other countries for essential prescription drugs.  Seventy-two percent of key pharmaceutical ingredients come from overseas, threatening the security of the supply chain and leading to shortages of essential prescription drugs. In fact, 29 of the 40 critical drugs for COVID-19 patients were in shortage at the start of the pandemic.  

The American Made Pharmaceuticals Act would reduce our dependence on foreign countries for these 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. 

“This is commonsense legislation,” said Rep. Mullin. “There is no reason the United States should continue their reliance on foreign countries when we’re capable of boosting production here at home. This bill will create more opportunities in America for good paying jobs, and it will lessen the chance of drug shortages due to supply chain issues like the ones we have experienced over the past year.”

“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.”

“The United States cannot solely rely on overseas manufacturers for our lifesaving drugs and critical medical supplies.” said Rep. Craig. “It’s long past time we invested in our own manufacturing capabilities, which will help to create good-paying jobs and lessen our dependence on foreign competitors. I’m proud to  help introduce this bipartisan legislation with my colleagues and look forward to supporting future efforts to shore up our pharmaceutical supply chain and incentivize domestic manufacturing.”

“CPA has long supported a comprehensive, legislative solution to bring generic drug manufacturing back to the United States,” said Michael Stumo, CEO of CPA. “Our report provides clear evidence that foreign manufacturers used a race to the bottom in price scheme that triggered offshoring of America’s domestic production of essential generic medicines, widespread illegal price manipulation, shortages of life-saving medicines, and poor quality, unsafe generic drugs. CMS spends more than $300 billion each year in drug procurement—the largest market in the world—and Congress should require those taxpayer dollars are spent buying American-made medicine. On behalf of CPA and our members, we applaud Senators Tina Smith (D-MN), Tom Cotton (R-AR), and Representatives Angie Craig (D-MN) and Markwayne Mullin (R-OK) for introducing this critical bill. The American Made Pharmaceuticals Act is exactly the kind of industrial strategy legislation that our nation needs to protect patients from foreign price gouging and shortages, protect us in times of crisis, and achieve the domestic manufacturing innovation and capacity that is necessary to ensure American patients get the drugs they need at a reasonable cost.”

“Coherus is proud to have our manufacturing here with American workers and we aim to continue American manufacturing with our future products, which is why we fully support U.S. Senators Tina Smith and Tom Cotton introducing the American Made Pharmaceuticals Act,” said Denny Lanfear, CEO and President, Coherus BioSciences. “The passage of The American Made Pharmaceuticals Act will help create manufacturing jobs and ensure surety of supply in the United States so that we can continue to bring safe, high quality, and lifesaving medicines to millions of Americans.” 

“Global conflicts expose that we are overly reliant on foreign sources for life-saving drugs and treatments,” said David Sanders, Executive Director, Securing America’s Medicine and Supply (SAMS) “We fully support The American Made Pharmaceuticals Act. Our country needs more U.S. and ally-based capacity, from vaccines and generics to complex biologics and biosimilars. Senators Tina Smith and Tom Cotton are leading their colleagues by recognizing and rewarding pharmaceutical manufacturing here. Medicare, and other government programs, should recognize and reward high quality products made here.” 

“Amneal applauds Senators Smith and Cotton and Representatives Craig and Mullin on their strong efforts to support pharmaceutical manufacturing here in the United States,” said Chirag Patel, President & Co-CEO of Amneal Pharmaceuticals.  “U.S.-based manufacturing has been a core focus for Amneal, and we support fully Congressional action that encourages domestic manufacturing and re-shoring of production for these critical medicines, which will create security of supply for America’s citizens and the businesses that have invested in the U.S.”  

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.

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