US Pandemic Emergency Manufacturing Act Submitted Again By Warren, Schakowsky

Pandemic Emergency Manufacturing Act authorizes federal government and its contractors to make personal protective equipment, Rx drugs, ventilators, respirators and vaccines as well tests for coronavirus, including OTC products, to address the public health emergency.

The US government would use its own facilities or contract with manufacturers to make “critical medical products,” including OTC at-home diagnostic kits, needed to combat COVID-19 under legislation introduced by Sen. Elizabeth Warren and Rep. Jan Schakowsky.

The Pandemic Emergency Manufacturing Act of 2021, S.187, authorizes the federal government and its contractors to make personal protective equipment, prescription drugs, tests for SARS-CoV-2 — the virus that causes COVID-19, ventilators, respirators, and vaccines to address the public health emergency. 

The job would be carried out by an agency the bill introduced on 2 February would establish, Emergency Office of Manufacturing for Public Health. The office would ensure an adequate supply of devices, diagnostics, drugs, biological products, supplies and equipment necessary to diagnose, mitigate and treat COVID-19 and to address product shortages.

“Our bill enables the federal government to rapidly produce the equipment, supplies, vaccines and prescription drugs Americans need, when they need it the most,” said Warren. She also noted that as a new member of the Finance Committee with jurisdiction over Medicare and Medicaid services, she would keep a sharp lookout at uses of the products required by the bill that would be directed to Medicare/Medicaid beneficiaries.

Warren, D-MA, and Schakowsky, D-IL, initially introduced the bill in 2020 as the “COVID-19 Emergency Manufacturing Act,” but it didn't move in either chamber before the end of the 116th Congress.

The text of their latest bill was made available by Warren's office. The text wasn't available from the Congressional Record and Schakowsky's bill had not been assigned a number through 11 February. 

The legislation might have a better chance currently as an amendment to the the next COVID-19 relief and economic stimulus package that passed the Senate through a budget reconciliation process and is being discussed this week by the House Energy & Commerce Committee. (Also see "CBD Regulation Bill Filed In US House Again; VMS In Pre-Tax Savings Accounts In First Senate Vote" - HBW Insight, 5 Feb, 2021.)

The Biden administration didn't wait for Congress to provide funding for supplying OTC COVID-19 tests for US consumers.

The White House on 1 February announced the US is paying Australian digital diagnostics firm Ellume Ltd.'s US business $231.8m to to build a factory to boost production of its COVID-19 at-home diagnostic test that provides results in 15 minutes and is available nonprescription. Until the facility is built for Ellume USA LLC based in Valencia, CA, the US will receive half the tests Ellume manufactures at its headquarters in East Brisbane, Australia. (Also see "US Supply Of OTC COVID-19 Tests Gets Boost Through $231.8M Contract For Australian Firm" - HBW Insight, 1 Feb, 2021.)

Consumer demand for home-use COVID-19 tests points to a growing market for OTC diagnostic products. Regulatory approval for direct-to-consumer sales of sample-collection kits can be as complicated as the technology behind their products – the first at-home test for SARS-CoV-2 allowed for OTC distribution was cleared in the US nearly a year after a national health emergency was declared due to the pandemic. (Also see "OTC Diagnostics Forecast: Growing With Pandemic But High Bar For Approval Could Slow Spread" - HBW Insight, 13 Dec, 2020.)

Federal Agencies Would Deliver Supplies, Tests At No Cost

In addition to the Emergency Office of Manufacturing, the legislation would:

• Require the office to manufacture, or enter into contracts to manufacture, COVID-19 products and other critical medical devices and drugs in short supply, at no costto federal, state, local and tribal health programs, and to sell COVID-19 products at cost to international and other commercial entities.

• Direct the office to begin manufacturing, or entering into contracts to manufacture, personal protective equipment, diagnostic test materials, and COVID-19 treatment drugs within one month of the act’s passage.

• Provide transparency into the office’s activities by mandating Health and Human Services Inspector General reviews of all the office’s contracts and requiring periodic reports to Congress on those activities, as well as mandating that the office publicly post its prices for the COVID-19 products.

A different version of this article previously was published by Informa Pharma's Medtech Insight newsletter.