Emergency Response

HHS’ new $6.5 million investment in two commercial diagnostic laboratories aims to expand the U.S. testing capacity by 1 million tests per week by utilizing excess supply and expanding the lab workforce, according to Brett Giroir, HHS assistant secretary.

President Donald Trump will sign a “buy American” executive order Thursday afternoon (Aug. 6) that directs FDA to work closely with the Environmental Protection Agency (EPA) to speed domestic approvals of essential medical products, loosen continuous manufacturing regulations, identify supply chain vulnerability, and target dangerous counterfeit drug and medical product imports.

As lawmakers and industry experts criticize lack of federal coordination and slow turnaround times on COVID-19 diagnostic tests, HHS Assistant Secretary for Health Brett Giroir asserted that reports of widespread delays in receiving test results are largely inaccurate and that there are no significant problems with securing testing supplies.

Doctors from Detroit’s Henry Ford Health System have yet to hear back from FDA about their emergency use authorization request for the anti-malarial drug hydroxychloroquine, as President Donald Trump continues to tout the drug as a treatment for COVID-19.

Senate Judiciary Committee Chair Lindsey Graham (R-SC) and Senate health committee Chair Lamar Alexander (R-TN) introduced bills Monday (July 27) that aim to ramp up domestic procurement and manufacturing of medical products, and provide tax credits to qualifying personal protective equipment manufacturers.

Over the weekend, FDA granted the first emergency use authorization (EUA) for a COVID-19 pooling test to Quest Diagnostics.

A Massachusetts-based nurses union is pushing back on the Trump administration’s calls for health care workers on the frontlines of COVID-19 response to reuse personal protective equipment, including N95 respirators.

The National Institute of Allergy and Infectious Diseases has merged four NIAID-funded clinical trial networks to create a new trial network that will recruit thousands of patients into large-scale clinical trials for investigational COVID-19 vaccines and monoclonal antibody therapies.

FDA last week told labs they could combine and test multiple patient COVID-19 diagnostic test samples using a new “pooling” technique laid out by the agency in a set of updated testing templates, coming just days before National Institute of Allergy and Infectious Diseases Director Anthony Fauci told The Washington Post that health officials were having “intense discussions” about pivoting to the new testing approach.