I am not the only one sounding the alarm about the need to rid ourselves of a regulatory apparatus that poses a threat to public health. Dr. Jeffrey Singer of the Cato Institute and a surgeon of 35 years said it best, “As in the early days of the COVID pandemic, tests were initially only done at the CDC and some of its 67 designated federal laboratories in 48 states. … Several days can go by before confirming a patient has monkeypox. … Hopefully the FDA will not repeat the mistakes of March 2020 by throwing regulatory sand in the gears of academic and commercial laboratories that are responding to the demand for rapid monkeypox tests.”

Recently, the Stanford University School of Medicine announced its Clinical Virology Laboratory developed an in‐house PCR test for monkeypox that bypasses the CDC confirmation system and provides a result in 24 to 48 hours. But because of FDA rules, the lab has to wait for an emergency use authorization before it can assist in the effort to roll out mass testing.

This is the kind of red tape Congress should keep in mind when deciding how lab tests should be regulated and how disease outbreaks should be handled.

After watching the CDC fumble the COVID-19 outbreak, one would think both sides of the aisle would join hands and return the freedom to develop diagnostic testing to the universities instead. Yet the Senate Health, Education, Labor, and Pensions Committee recently passed a bill that takes the freedom of university labs to innovate and places them under the thumb of the FDA.