“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Dr. Margaret A. Hamburg in a written statement. “Inaccurate test results could cause patients to seek unnecessary treatment, or delay and sometimes forgo treatment altogether.” Currently the FDA does not oversee the sale of laboratory-developed tests that are designed, manufactured and used in a single lab. The move to regulate comes out of growing concerns that some tests may provide inaccurate results. Under the current rules, makers do not have to prove whether such tests actually identify illnesses.
Additional regulation for laboratory-developed tests has been sought since 2006, but has been met with opposition by product makers and labs that deem FDA rules unnecessary, since labs already go through a regulatory process overseen by the CMS under the Clinical Laboratory Improvement Amendments of 1988.
“It's very duplicative of the regulation that we're already under with CLIA,” said Alan Mertz, president of the American Clinical Laboratory Association, an industry trade group based in Washington, D.C. “It doesn't really eliminate and replace many of the requirements that we already go through.”
Mertz said he felt the added FDA regulation would be a cumbersome process for those labs that develop tests, since they would be required under the proposed rule to register as a device maker with the FDA, while also adhering to regulatory requirements set forth by CLIA.
“It could really stifle innovation,” Mertz said. “The prospect of putting these tests through this process might chill innovation if labs make the decision to either not create the test in the first place, or not to continue to offer it.”
Some companies do voluntarily seek FDA approval for their tests, and thereby compete with products that have not undergone the same types of review and study to support their claims for use, according to the agency.
The proposed guidance would be for higher-risk tests that have the same intended use as those that have already received FDA approval. Lower-risk tests, those for rare diseases, and ones for which there are no comparable FDA-approved tests would be excluded from oversight.
Those who support FDA regulations for such laboratory-developed tests say claims that FDA oversight would negatively impact innovation have been overblown, arguing that such oversight is needed to lessen the risk of providing unnecessary treatments to patients because a test gave a false positive result.
“What we all struggle with is the balance between innovation and knowing that that innovation is clinically valid,” said Elissa Passiment, executive vice president for the American Society for Clinical Science, a Virginia-based group that advocates for safe and cost-effective laboratory services. “That is difficult when a laboratory develops a test and starts to market it and there's no data that tell you whether or not that test does what it says it does.”
The letter sent to Congress Thursday provided lawmakers with 60 days notice before the FDA publishes its proposed guidance for public comment.
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