Public health experts on Friday raised alarm over a new policy unveiled by the Health and Human Services Department blocking the Food and Drug Administration from regulating a number of laboratory tests including those that test for Covid-19.
The administration announced on the HHS website that it wants many tests for the coronavirus and other diseases to reach the market without the regulatory process which ensures the tests are accurate and not fraudulent.
Erick Turner, a former FDA employee who reviewed psychiatric drugs, wondered whether the administration's next step would be to allow vaccines and treatments to reach the market without proper review.
What?! HHS directing FDA not to review lab tests before they are marketed?
What’s next, HHS directing FDA not to review drugs or vaccines so they can go straight onto the market? https://t.co/ojLtLdfPiL
— Erick Turner (@eturnermd1) August 20, 2020
As it has during other public health crises like the H1N1 pandemic of 2009 and the Zika outbreak of 2015 and 2016, the FDA is requiring emergency use authorizations (EUA) for coronavirus tests. The administration claims the FDA lacks the legal authority to regulate such tests—a claim vehemently denied by FDA commissioner Steven Hahn.
The decision comes seven months into the crisis, as the U.S. faces a shortage of chemicals and other supplies needed to test people for Covid-19 with the prompt and accurate results needed to mitigate the spread of the virus.
Supporters of the administration's move, including some lab experts, say it will allow more "innovative" tests to reach the market, but Dr. Joshua Sharfstein of Johns Hopkins University is among the critics saying the FDA's regulatory review process during public health emergencies is in place to protect the public.
Those cheering the heavy handed move by @HHSGov to stop @US_FDA from protecting Americans from false #COVID19 tests don’t realize how much can go wrong. A far better approach would be to let the FDA keep using the flexibility in the law to separate good tests from bad.
— Joshua Sharfstein (@drJoshS) August 21, 2020
Trump critics deny that EUAs for coronavirus tests are to blame for testing delays, pointing instead to the administration's failure to heed warnings about Covid-19 that came as early as January from public health experts including federal scientist Rick Bright.
The president has claimed numerous times throughout the crisis, including in March when the coronavirus spread was classified as a worldwide pandemic, that the disease would simply disappear. In June, as experts pushed for an increase in testing capacity, Trump countered that "slowing the testing down" would result in fewer positive tests and would improve the United States' coronavirus numbers.
Trump also has suggested the FDA's regulatory process for treatments is politically driven, complaining about the agency's refusal to approve untested treatments like convalescent plasma without first proving they are effective.
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"You have lot of people over there that don't want to rush things," Trump said this week. "They want to do it after November 3rd."
The president has spent much of his term working to dismantle regulatory processes to help quickly push through projects that are aligned with his policy agenda; last month, he finalized a rule gutting the National Environmental Policy Act (NEPA), which for decades has implemented a regulatory review process for infrastructure projects to ensure they won't harm the environment. The rollback was aimed at pushing projects through more quickly.
In the case of a deadly pandemic in which Americans are relying on accurate tests to determine whether they could be spreading Covid-19, former FDA official Alberto Gutierrez told the Washington Post, weakening the FDA's regulatory process is akin to "letting the Wild West be the Wild West" to the detriment of public health.
"That doesn't actually help," Gutierrez said. "In the end, it harms more than it helps."
Critics within and outside the FDA say HHS's regulatory rollback may be the administration's way of deflecting blame for the delays people are still facing as they wait for coronavirus test results. As the Post reported:
In February, the administration was relying almost entirely on a test developed by the Centers for Disease Control and Prevention—which is standard practice during public health crises—but the test was faulty. It took three weeks for the FDA to loosen restrictions that allowed other tests—at that time, mostly laboratory-developed tests—to come to market. Azar was head of the coronavirus task force at the time. The move, FDA backers say, may be an effort to allow Azar to argue he took action, albeit belatedly, to improve testing.
Throughout February, academic medical centers and others became increasingly vocal that the FDA was too slow and bureaucratic in reviewing laboratory-developed coronavirus tests. On Feb. 29, the agency responded by making changes that allowed the labs to start using their tests after validating them—but still required them to apply for emergency use authorizations. The FDA has since approved scores of such tests for the coronavirus and even more tests that are not laboratory-developed.
Scott Becker, CEO of the Association of Public Health Laboratories, wondered "why this reversal by HHS was done now, given the oversight process seemed to be working."
Farzad Mostashari, former national coordinator for health information technology at HHS, compared the department's move to "closing the barn door six months after the horse left the barn."
"We wasted WEEKS in a critical phase of the outbreak, overly reliant on the flawed CDC tests, but by March the EUAs were rolling out finally," Mostashari tweeted. "By May, FDA had issued a new policy making it pretty darn easy for new lab-developed tests to get the EUAs. In fact, they have had to revoke some EUAs when we learned the tests didn't perform well, with lots of false positives or false negatives."
"That's why you need oversight," he wrote.