Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed urges administration to communicate on DPA; FDA posts third-party report for Q1, FY 2021.
The U.S. Senate Finance Committee met for a second time in three days to address the supply of personal protective equipment (PPE) for the COVID-19 pandemic. While a witness said the Defense Production Act (DPA) is no panacea for production, one message emerging from the hearing is that producers need to hear from end users about demand just as much as users need to know about available inventories.
The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak.