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The Food and Drug Administration issued a rule on Monday that brings new scrutiny to a vast array of critical lab tests, including some popular prenatal genetic screenings, that reach patients without any federal agency checking to ensure they work the way their makers claim.
“This is a significant step forward,” said Peter Lurie, president and executive director of the Center for Science in the Public Interest and a former FDA associate commissioner. These tests have “always been one of the remaining gaping holes in the FDA regulatory structure. And it’s great to see that the agency has taken concrete steps to close it.”
The new rule cites coverage of the issues with lab-developed tests by multiple media outlets and researchers, including ProPublica articles: one that revealed problems with prenatal genetic screenings, popularly known as NIPTs or NIPS and the other on faulty lab-testing for COVID-19 overseen by one company.
The move comes after decades of debate and stalled legislation on LDTs, which also include certain cancer screenings as well as some tests for rare diseases. Because these tests are designed, manufactured and used in a single lab, they escape most federal oversight over marketing and accuracy.
A large coalition of labs, associations and academic medical centers have long pushed back on the prospect of increased FDA involvement in these tests. It would be too onerous, they’ve argued, and it jeopardizes patient access to health services.
One of nearly 7,000 comments submitted in response to the draft rule came from the Association for Molecular Pathology, representing a wide-ranging group of professionals associated with laboratory testing. The FDA’s proposed changes “would result in laboratory professionals being treated as product manufacturers instead of board-certified healthcare providers,” the association’s president wrote, and it would “unequivocally hinder and harm patient care.”
The agency’s hands-off approach dates back to an era when these tests were a relatively small, low-risk sector of the health care system. Now, they are a much bigger player and include high-stakes tests made by commercial companies. While the Centers for Medicare and Medicaid Services reviews lab operations, it doesn’t check whether the tests themselves are clinically valid. The tests aren’t registered with the federal government, so nobody knows how many exist. In 2021, Pew Charitable Trusts estimated that 12,000 labs are likely to deploy them, many of which process thousands a day.
The ProPublica story on prenatal genetic screenings referenced by the FDA revealed how the agency didn’t check the tests before they reached patients or evaluate marketing claims made by the companies that sell them. Companies aren’t required to publicly report when a test gets it wrong, the investigation found, and no federal agency can recall faulty screenings. The story detailed how false positives, false negatives and indeterminate results can have painful consequences for expecting parents. (We also published a guide to the prenatal tests to help families with their questions.)
Our coronavirus investigation showed how a Chicago-based company with state and local contracts in Nevada sold testing services that were unreliable from the start. As it became clear that the lab was telling infected people that they had tested negative for the virus, company officials nonetheless expanded the reach of the lab’s testing. The company declined to comment for ProPublica’s previous stories on these problems.
The rule will go into effect over a four-year period. Within two years, test-makers will be expected to meet registration and listing requirements, among others, which is “a critical part of this rule,” according to Cara Tenenbaum, a former FDA policy adviser whose consultancy has advocated for more active oversight.
“At least knowing what is out there will be huge,” she said in an email.
High-risk tests will need to meet new FDA review requirements before reaching the marketplace starting in November 2027. Moderate-risk and low-risk tests will need to do the same starting in May 2028. It’s unclear how prenatal screening tests would be categorized.
The agency generally will not enforce some or all requirements for certain LDTs, including tests that were first marketed before the rule was issued and have not since been modified or have been modified in certain limited ways.
The agency will also generally not enforce some or all requirements for tests used within the Veterans Health Administration or the Department of Defense, as well as certain tests that meet other narrow conditions.
Nonetheless, the rule marks a massive shift in the FDA’s approach to a sector that touches millions. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” FDA commissioner Robert Califf said in an agency news release.
The final rule, he added, aims to “help ensure that important health care decisions are made based on test results that patients and health care providers can trust.”
The FDA tried to rein in the lab tests a decade ago, issuing a draft guidance in 2014. That prompted a two-year backlash from opponents. The agency ultimately dropped it.
Some critics have argued that regulation of LDTs should happen through legislation rather than rulemaking. But many also largely opposed a bipartisan bill in 2022 that came the closest to passing before ultimately being dropped at the end of the year. Later efforts to move a similar bill forward have not gained traction in Congress.
Laurie Menser, chief executive of the Association for Molecular Pathology, said in an emailed statement that the association is “very disappointed” in the new rule.
“It’s unfortunate the agency continues to overstep its authority and bypass the country’s legislative process,” Menser said. “AMP is currently reviewing the different aspects of the rule and assessing the many implications for our members and patient care.”
Lurie, who was closely involved with the FDA effort to address the tests a decade ago, said the rule has been a long time coming. “People had identified this problem a very long time ago, and wanted to take action, but found themselves stymied by opposition,” he said.
“I think that it shows real courage on the part of the agency, as well as commitment to the public health, to take this step,” he added.
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After years of legal battles, Philips has agreed to pay more than $1 billion to settle lawsuits waged by thousands of people who say they were injured by breathing machines capable of releasing toxic particles and fumes into their noses, mouths and lungs.
The proposed settlement unveiled Monday between the global manufacturer and plaintiffs’ lawyers will effectively end more than 700 lawsuits filed after the 2021 recall of millions of the company’s widely used sleep apnea devices and ventilators.
More than 50,000 people are involved in the litigation. It has yet to be determined how many will have claims that fall under the terms of the settlement, which will be filed in federal court in Pittsburgh.
Philips also agreed to provide $25 million to cover the cost of medical monitoring for users who are fearful that hazardous chemicals emitted from the machines could lead to long-term harm, including cancer. Since 2021, the Food and Drug Administration has received more than 500 reports of deaths reportedly associated with the machines since 2021.
Plaintiffs have said that Philips, which built the devices at two factories near Pittsburgh, should be held accountable for failing to pull the machines off the shelves years ago.
“I still don’t have my husband,” said Shawne Thomas of Louisiana, whose 51-year-old husband, Rodney, died from a rare form of nose and throat cancer in 2021 after using one of the recalled machines for months. “But it sounds like a good amount of money coming out of their pocket, so it makes me feel a little bit happier.”
An investigation by ProPublica and the Pittsburgh Post-Gazette last year revealed that Philips suppressed thousands of complaints about an industrial foam fitted inside the machines that could break down and send potentially dangerous material into the masks worn by users. Federal law requires medical device makers to turn over such reports to the FDA within 30 days.
Under the terms of the settlement, Philips did not admit fault or liability. In the company’s first quarter financial report on Monday, CEO Roy Jakobs said the settlement provides the company with a “clear path forward for sustainable value creation.”
He also cited what he called “reassuring test results” for the recalled machines.
In launching the recall, Philips said the degrading foam inside the machines could cause serious harm and carried cancer-causing materials. The company has since walked back those findings, saying further testing did not indicate using the devices could result in “appreciable harm to health.”
ProPublica and the Post-Gazette found that the FDA repeatedly questioned the safety claims by Philips, saying the tests were not adequate and further evaluation was needed. The news organizations obtained several reports detailing the results of tests on the foam. Those tests found that the material tested positive for genotoxicity, the ability of chemicals to cause cells to mutate, which can cause cancer.
This month, under the terms of a consent decree with the federal government, the company agreed to hire an independent safety monitor and submit to regular inspections for five years. Philips also agreed to stop selling its sleep apnea devices in the United States until the conditions in the agreement were met. The agreement does not restrict Philips from selling its breathing machines in other countries.
Last year, Philips also agreed to pay more than $479 million to compensate customers for the cost of the defective machines — an amount that plaintiffs’ lawyers say is now expected to top $600 million.
Several medical experts interviewed by ProPublica and the Post-Gazette say that it could take years to determine whether links exist between the machines and certain diseases, but that they believe the company should have warned the public about the health risks years earlier.
“I’m glad they’re taking responsibility for what they did because they knew,” said Louisiana Sheriff Brett Stassi, who was diagnosed with kidney cancer and rushed into surgery in 2021 after using one of the recalled devices for four years. “They put dollars over lives in my book.”
A criminal probe by the U.S. Department of Justice is ongoing, and the Government Accountability Office, the investigative arm of Congress, is launching an inquiry of the FDA’s oversight of medical device recalls for the first time in years.
Philips has said it is cooperating with authorities.
The FDA has defended its handling of the crisis, saying it acted as soon as it learned of the safety concerns in April 2021, just weeks before Philips launched the recall.
“The FDA welcomes the opportunity for GAO review of the agency’s oversight of medical device recalls,” the agency said in a statement early this year.
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