FDA Takes Action to Regulate Lab Tests It Says Put Patients ‘At Risk’ | ET REALITY


The Food and Drug Administration said Friday that it was taking steps to close what has been widely seen as a loophole that allows certain laboratory tests, such as those that determine the profile of a tumor or the genetic health of a fetus, evade review with virtually no problem. monitoring or supervision.

The agency proposed a rule that would place the tests under its regulatory authority, requiring the laboratories that perform them to provide data on the accuracy of the tests. Hundreds of tests on the market have very little oversight and can be misleading to the public and patients seeking to know if they have Lyme disease, Alzheimer’s, or will develop cancer.

The proliferation of these tests “leaves Americans vulnerable to making important health care decisions based on potentially flawed or inaccurate test results,” FDA Commissioner Dr. Robert Califf said at a news conference on Friday.

The tests, which included the first to detect Covid-19, have been the subject of agency concern for 30 years and have been a perennial, if essentially untouchable, goal of lawmakers. back to former senators Edward Kennedy and Barack Obama and as recently as this year.

Academic medical centers that include labs that operate the tests have opposed the changes, citing the importance of being agile in the face of a rapidly changing, pandemic-prone world.

Although the renewed attention on the tests’ accuracy may be unsettling for patients, there have been few clues available to them (or even their doctors) about whether the tests were vetted or received extensive oversight from the FDA, according to Jeff Allen, president of Friends. of Cancer Research, a nonprofit organization funded in part by pharmaceutical companies.

“A rule like this is about reaching out from the beginning to make sure each test meets reliable accuracy standards, so you don’t need to ask those questions,” he said.

Allen said a hospital pathology lab may know the origins of a test, but that information is rarely conveyed to doctors and patients. He said his organization was concerned about the accuracy of tests administered to obtain the genetic profile of a tumor that led to treatment decisions.

An investigation by The New York Times found that prenatal genetic screening tests were frequently erroneous, with many false positive results.

Other similar tests have also been criticized by academic researchers, doctors and the FDA. Those include tests that are intended to calculate a person’s so-called genetic propensity to develop diabetes or become an elite athlete.

Doctors have also raised concerns about tests aimed at predicting the chances of developing Alzheimer’s disease. In 2015, the FDA issued a report about 20 concerning tests, including one to screen for ovarian cancer and another for Lyme disease. A long-standing concern about the tests is whether they have misled patients facing decisions about aborting a fetus with a possible genetic abnormality or undergoing a mastectomy or hysterectomy based on cancer screenings.

Opponents of additional FDA oversight say the agency does not have the resources to review and monitor testing for emerging health problems.

Susan Van Meter, president of the American Association of Clinical Laboratories, which represents laboratory companies and test manufacturers, said in a statement that billions of tests are performed each year, influencing most decisions made by health care providers.

The association noted that the only test now available to detect fentanyl mixed with a dangerous animal tranquilizer, xylazine, a combination known as “tranq dope,” would be subject to the new layer of oversight.

“The FDA is at serious risk of falling behind on its current public health priorities,” according to the association’s report. statement released on Friday. The association said it planned to ask the agency to withdraw the proposed rule and said it would continue to work with Congress on the matter.

An attempt to update oversight of laboratory testing failed late last year in Congress after advocacy groups spent countless hours reaching a compromise. Called the Valid Law, the measure was expected to be approved in a general budget bill, but was ultimately not included. Was reintroduced at the beginning of this year.

Regulatory pathways for laboratory tests generally depend on who analyzes the test. Tests manufactured by a company and performed by a consumer or healthcare provider tend to be regulated by the FDA, which requires the test manufacturer to evaluate and report on its accuracy.

Less regulated tests, known as “lab-developed” tests, tend to be processed at a central location and results transmitted to consumers or healthcare providers. Those tests may be overseen by Medicare laboratory experts and may also be accredited by the College of American Pathologists.

The FDA isn’t even sure how many lab-developed tests exist.

“No one really knows how many of these tests exist, or who makes which ones, much less which tests have a history of poor results and problems and which don’t,” said Dr. Jeffrey Shuren, director of the Division of Diagnostics and Medical Devices at the FDA, during Friday’s briefing.

The proposed rule will be open to public comment and will likely be challenged in court, said Jeffrey Shapiro, a King & Spalding attorney who represents some labs that have developed tests.

He said lab-developed tests are services or procedures that are already regulated by Medicare officials.

“This proposed rule is nothing new, it is the same dispute the FDA has been having with industry for 30 years,” Mr. Shapiro said. “Important economic issues like this that affect the health of millions of people should be decided by Congress, not the FDA.”

The agency also noted how long the debate over these unregulated tests has dragged on, with Dr. Califf acknowledging on Friday that the agency had to grapple with how prolific the testing had become.

“Laboratory-developed tests play a central role in U.S. healthcare, and many are similar to other tests that come to the FDA for review,” Dr. Califf said. “This approach no longer makes sense and puts American patients at risk.”

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