The Trump administration this week ordered the Food and Drug Administration to allow the use of a certain class of laboratory tests, including some for the coronavirus, without first confirming that they work.
For months some F.D.A. officials have worried that the pandemic would provide an opening for clinics, academic institutions and commercial labs to get what they had long been lobbying for: the leeway to develop their own laboratory tests for various diseases without F.D.A. oversight. On Wednesday that became a reality.
Some lawmakers are also troubled by the change, particularly during a public health emergency when the need for accurate coronavirus tests is high. The F.D.A. has required that it provide emergency authorizations for lab-developed tests during other outbreaks.
The announcement “is deeply concerning and suggests that the Trump Administration is once again interfering with F.D.A.’s regulation of medical products,” Representative Frank Pallone, Jr., of New Jersey, chairman of the House Energy and Commerce Committee, said in a statement.
“I do not believe that now is the time to reduce oversight of COVID-19 tests,” he said.
While most common laboratory tests are commercial tests, manufactured and marketed to multiple labs, other tests are developed and validated within one particular laboratory. These tests, called “laboratory-developed tests” or LDTs are used solely within that laboratory and generally are not distributed or sold to any other labs or health care facilities, although some work with mail-in samples.
The new policy states that lab-developed tests will no longer require F.D.A. authorization.
“This deregulatory action will better prepare us for future pandemics while maintaining regulatory safeguards for quality and accuracy,” said Brian Harrison, the chief of staff of the Department of Health and Human Services.
The administration faced widespread criticism for failing to make coronavirus tests available earlier in the outbreak, and for ongoing shortages and delays. But critics say that freeing all lab-developed tests from F.D.A. scrutiny — including those for cancer, Alzheimer’s disease, and genetic conditions — will pose new problems.
“I think it’s quite alarming,” said Jeff Allen, president and chief executive of Friends of Cancer Research. He noted that a growing number of tests are in development to help determine whether cancer patients are responsive to certain drugs. “It’s really important for the performance of those tests to be assured.”
Mr. Allen and other critics also note that the new plan appears to leave the F.D.A. with no knowledge of what lab-developed tests are being devised, much less how they are performing.
“Suppose you get a Covid test and you actually have the infection and it comes back negative,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “You may believe you’re OK and that may leave you in your home, exposing family and friends to the virus when you should quarantine.”
Earlier this year, the F.D.A. noted just that problem. In response to an inquiry, agency spokeswoman Emma Spaulding said in a statement in May that there were problems with some of the laboratory coronavirus tests whose developers had applied for emergency authorization.
The Coronavirus Outbreak ›
Frequently Asked Questions
Updated August 17, 2020
Why does standing six feet away from others help?
- The coronavirus spreads primarily through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using that measure, bases its recommendation of six feet on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete protection. Sneezes, for instance, can launch droplets a lot farther than six feet, according to a recent study. It’s a rule of thumb: You should be safest standing six feet apart outside, especially when it’s windy. But keep a mask on at all times, even when you think you’re far enough apart.
I have antibodies. Am I now immune?
- As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.
I’m a small-business owner. Can I get relief?
- The stimulus bills enacted in March offer help for the millions of American small businesses. Those eligible for aid are businesses and nonprofit organizations with fewer than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The help being offered, which is being managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan program. But lots of folks have not yet seen payouts. Even those who have received help are confused: The rules are draconian, and some are stuck sitting on money they don’t know how to use. Many small-business owners are getting less than they expected or not hearing anything at all.
What are my rights if I am worried about going back to work?
- Employers have to provide a safe workplace with policies that protect everyone equally. And if one of your co-workers tests positive for the coronavirus, the C.D.C. has said that employers should tell their employees — without giving you the sick employee’s name — that they may have been exposed to the virus.
What is school going to look like in September?
- It is unlikely that many schools will return to a normal schedule this fall, requiring the grind of online learning, makeshift child care and stunted workdays to continue. California’s two largest public school districts — Los Angeles and San Diego — said on July 13, that instruction will be remote-only in the fall, citing concerns that surging coronavirus infections in their areas pose too dire a risk for students and teachers. Together, the two districts enroll some 825,000 students. They are the largest in the country so far to abandon plans for even a partial physical return to classrooms when they reopen in August. For other districts, the solution won’t be an all-or-nothing approach. Many systems, including the nation’s largest, New York City, are devising hybrid plans that involve spending some days in classrooms and other days online. There’s no national policy on this yet, so check with your municipal school system regularly to see what is happening in your community.
“Some of the laboratories didn’t do their validation properly, making it impossible to tell if they had a good test or not,” Ms. Spaulding said. “Others included data that suggested the test did not perform well, likely missing far more positive cases than authorized tests.”
Other laboratories, she added, had manufacturing problems such as contamination. And several made unsupported claims in their labels for home testing.
With the new change, the agency would not find out about these problems. Under the policy, the F.D.A. retains the power to give emergency authorizations to companies that voluntary apply for them. The agency may also attempt to institute new rules for these tests, but would have to go through a cumbersome formal review process first. Such rules are subject to White House approval.
The new policy covers tests developed by laboratories certified under the Clinical Laboratory Improvement Amendments program, which is part of the Centers for Medicare and Medicaid Services. It does not change the requirements for tests that are made and marketed by companies to be sold off site, such as the rapid point-of-care tests for the coronavirus.
Susan Van Meter, executive director of AdvaMedDx, the diagnostic division of AdvaMed, the medical device trade group, said her organization was still trying to assess the implications of the policy. Ms. Van Meter also said her organization would like to see the F.D.A.’s entire policy on lab-developed tests updated.
“We really think a new, overarching, modernized regulatory framework for all diagnostic tests” is important, she said.