New U.S. Legislation Introduced to Address COVID-19-related Pharmaceutical Manufacturing

U.S. Senator Warren, has introduced legislation titled, “COVID-19 Emergency Manufacturing Act” (Act).  The Act gives the federal government the power to manufacture certain goods, including pharmaceuticals needed to address the Covid-19 issue.  The Press Release states: 

Washington, DC - Today, United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Committee on Health, Education, Labor, and Pensions, and Representative Jan Schakowsky (D-Ill.), Chair of the Energy and Commerce Consumer Protection and Commerce Subcommittee, introduced the COVID-19 Emergency Manufacturing Act to publicly manufacture personal protective equipment, prescription drugs, and other medical supplies necessary to combat the COVID-19 pandemic. The legislation authorizes the federal government to manufacture medical products, including by contracting with existing manufacturers, to ensure the nation has an adequate supply of critical materials to avoid rationing during this unprecedented crisis. It will also help the nation begin to prepare for the approval of a COVID-19 vaccine by dramatically increasing our capacity for development and distribution 

In 2018, Senator Warren and Representative Schakowsky introduced the Affordable Drug Manufacturing Act to radically reduce drug prices through public manufacturing of prescription drugs and re-introduced it in 2019. The COVID-19 Emergency Manufacturing Act of 2020 builds off of the lawmakers' original public manufacturing bill to ensure that the federal government harnesses its full manufacturing, contracting, and coordinating capacity during the pandemic. 

The legislation builds on an existing model in which the federal government contracts with private manufacturers to produce drugs critical to national security, and for which there is often a limited or non-existent commercial market. 

. . . The COVID-19 Emergency Manufacturing Act will:  

• Establish an Emergency Office of Manufacturing for Public Health to ensure an adequate supply of drugs, devices, biological products, active pharmaceutical ingredients, and other supplies necessary to diagnose, mitigate, and treat COVID-19 and to address shortages in products used to treat non-COVID conditions and illnesses.
• Require the Office to manufacture, or enter into contracts to manufacture, COVID-19 products and other critical drugs and medical devices in shortage. The Office will be required to provide COVID-19 products at no cost to federal, state, local, and tribal health programs and to sell COVID-19 products at cost to international and other commercial entities. The Office will be required to sell the additional products it manufactures at a transparent and reasonable price to domestic and international entities.
• Direct the Office to begin manufacturing, or enter into contracts to manufacture, PPE, diagnostic test materials, COVID-19 treatment drugs within one month of the Act's passage. The Office will prioritize production of items that have most impact on public health and the economy, that address shortages, and that alleviate demographic disparities in COVID-19.

• Direct the Office to begin constructing, or enter into contracts to construct, vaccine and therapeutic manufacturing facilities to ensure the immediate production, at-scale, of COVID-19 vaccines when such vaccines become available.
• Provide transparency into the Office's activities by mandating Inspector General reviews of all of the Office's contracts, requiring periodic reports to Congress, and forcing the Office to publicly post its prices for COVID-19 and other products as well as any licensing agreements.