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FDA Highlights Importance of Advanced Medical Manufacturing to Support Health

August 04, 2020

Key takeaway: FDA officials have declared that advanced medical manufacturing, central to a recent proposal by Ways and Means Republicans, is key to supporting public health and preventing future pandemics.

  • A bill put forward by Ways and Means Rep. Brad Wenstrup (R-OHIO) supports advanced medical manufacturing by encouraging businesses to upgrade their production technology – a goal shared by the FDA.
  • The FDA’s new blog post was written by Dr. Stephen M. Hahn, Commissioner of Food and Drugs, and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs.

Top scientists from the Food and Drug Administration said modernizing manufacturing is essential to support public health and prevent future pandemics in a blog post on Monday, paralleling the objectives of legislation released by Republicans on the House Ways and Means Committee recently as part of Republicans’ agenda for economic growth and increasing American innovation in U.S. medicines and cures.

In the post, authored by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, the FDA argues that “advanced manufacturing” – which means to utilize new and emerging approaches to enhance the making of cures and treatments – will help increase the production and invention of new medical breakthroughs. Whether through 3D printing for medical devices or advancing new gene therapies, advanced manufacturing “enables innovation,” boosts efficiency, and improves “supply chain resiliency for medical products that provide wide-ranging public health benefits,” according to the FDA.

The FDA is also stated in their blog that America needs to focus on “medical countermeasures.”

“Potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures,” the FDA said.

The FDA is right: There are tremendous benefits to advanced manufacturing for all Americans. Which is why House Republicans are working to advance legislation that would help deploy these new medical throughs, benefiting patients, medical providers, and the economy.

Ways and Means Republicans, led by Rep. Brad Wenstrup (R-OH), introduced the Domestic Medical and Drug Manufacturing Tax Credit. This legislation lowers the tax rate on the income from the domestic manufacturing and sales of active pharmaceutical ingredients and medical countermeasures – giving manufacturers more immediate capital to invest in advanced manufacturing.

By providing a credit of 10.5 percent of the net income from the sale of these important medical products, this effectively cuts the corporate tax rate of 21 percent in half on these domestically manufactured products.

The bill also creates a 30 percent tax credit for new investments in advanced manufacturing equipment or machinery used in the U.S. to manufacture drugs, medical devices, or biological products. The credit phases down to 20 percent in 2028, 10 percent in 2029, and phases out in 2030.

Republicans argue that investments in advanced manufacturing will help the United States regain its status as a global leader in manufacturing. Additionally, doing so will help retain and create high paying jobs, support domestic innovation, and enhance national security and public health.

Investing in advanced manufacturing has long been touted as crucial for public health by the FDA. In 2019, the agency said that advanced manufacturing enables U.S.-based pharmaceutical manufacturing to regain its competitiveness with China and other foreign countries. FDA also stated that advanced manufacturing increases the resilience of our domestic manufacturing base and reduces quality issues that trigger drug shortages or recalls.

“America can be the world leader in innovation if we focus on economic growth and making the U.S. medically independent,” Ways and Means GOP Leader Kevin Brady (R-TX) said when Rep. Wenstrup introduced this legislation. “America is going to harness innovation to cure coronavirus, return drug manufacturing to the United States, and make America healthy again.”

Want to read more on the fight against Coronavirus? Read our Coronavirus Bulletin here which contains our extensive FAQ about recent federal actions.

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