Congress should rein in the FDA
Fewer than 500 — that’s the approximate number of coronavirus diagnostic tests that reportedly were conducted in the United States by late February. These tests are needed to stop the virus—to discover how far it’s spread, to accurately calculate its mortality rate, to determine who needs to be quarantined versus who can carry on with their everyday routines.
The primary reason the U.S. was behind the curve when it came to screening for the coronavirus is the bottleneck created by Obama-era Food and Drug Administration (FDA) policies that limited diagnostic testing to the purview of the Centers for Disease Control and Prevention (CDC).
Diagnostic laboratories are subject to extensive federal and state regulations and rigorous accreditation requirements, but FDA has for years sought to regulate diagnostic laboratories as medical device manufacturers. The agency was warned that the need for FDA approval risked impairing the ability of diagnostic laboratories to respond during infectious disease-related public health emergencies. Nevertheless, during the Obama years, the FDA took important steps to regulate diagnostic laboratories.
In March 2016, during an outbreak of Zika virus, FDA sent warning letters to licensed laboratories at Texas Children’s Hospital and Houston Methodist Hospital, demanding that the doctors consult with the agency. “Based on our review of your promotional materials, we believe you are offering a high risk test that has not been the subject of premarket clearance, approval, or Emergency Use Authorization review by the Food and Drug Administration,” FDA officials wrote. “The FDA would like to better understand the test’s design, validation and performance characteristics, and in addition, CDC and CMS have asked us to review the science behind your test.”
As a result of these assertions of authority, during the outbreak of coronavirus, CDC effectively had a monopoly on the coronavirus diagnostic-testing market, as its test was initially the only one FDA authorized to detect SARS-CoV-2 infections. Private laboratories — both hospital and commercial — found themselves needing FDA permission to deploy diagnostic tests.
Yet the FDA-authorized coronavirus diagnostic test kits developed and sent by the CDC to public health laboratories in early February were defective and unusable. “As a result of the CDC’s faulty test kits, local clinicians had to send individual samples into public health labs [which forward them to CDC] or directly to the CDC in Atlanta to perform the test, delaying testing and results for Americans who thought they were infected,” reports CNBC.
Although the FDA asserts its regulatory actions didn’t impede U.S. efforts to curb the spread of the coronavirus, the agency’s policies deterred some private laboratories from setting up tests for the virus and directly prevented others from using tests that were ready for implementation. In Washington state, the site of the first identified case of community spread of coronavirus, the University of Washington Medicine’s virology laboratory was ready to implement a coronavirus test, but FDA prevented it from doing so. Had this laboratory been allowed to begin testing its patients, we likely would have learned of the community spread of coronavirus weeks earlier, gaining valuable time in combatting the epidemic. As one professor with that laboratory said, “This virus is faster than the FDA.”
It’s important to enforce quality standards, but the policy shouldn’t hinder competent, talented private laboratories across the country from developing diagnostic tests that can preserve and even enhance public health. That’s exactly what happened here.
In response to this regulatory failure, Sen. Rand Paul (R-Ky.), who contracted and recovered from COVID-19, on March 17 introduced Senate Bill S.3512, entitled the “Verified Innovative Testing in American Laboratories Act of 2020,” also known as the VITAL Act. Congress and the president should support the VITAL Act and its principles to ensure that government regulatory approval never again gets in the way of saving lives from pandemics.
The VITAL Act would be a good start, but it is insufficient to rein in the overzealous FDA. FDA regulation continues to impede the U.S. coronavirus response in other ways. It is time for the Trump administration to take a closer look at how FDA’s overzealous regulation is hampering the U.S response to coronavirus.
C. Boyden Gray was counsel to Vice President George H.W. Bush, 1981-1989, and White House counsel, 1989-1993. He was U.S. ambassador to the European Union in 2006 and a special envoy for European and Eurasia affairs during the George W. Bush administration. He is now in private law practice in Washington.
Roger D. Klein, M.D., J.D., is a faculty fellow at the Center for Law, Science and Innovation at the Sandra Day O’Connor College of Law at Arizona State University and a policy adviser to the Heartland Institute.