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Nov. 10 — The FDA targeted direct-to-consumer genetic tests in three letters sent to companies in the first week of November.
The Food and Drug Administration sent the “untitled” letters to DNA CardioCheck and DNA4Life on Nov. 2 and Interleukin Genetics Inc. on Nov. 4, stating that their tests appeared to meet the definition of a medical device under Section 201 of the Federal Food, Drug, and Cosmetic Act and that the agency had no record of the companies being cleared to market the tests.
The letters aren't warning letters. Untitled letters, according to the FDA's regulatory procedures manual, cite violations that don't meet the threshold of regulatory significance for a warning letter.
In September, the FDA sent a letter to Pathway Genomics for direct-to-consumer (DTC) marketing of its liquid biopsy DNA tests. The Pathway letter also stated that the company appeared to be offering a “high risk test that has not received adequate clinical validation” and that could harm the public health.
There was no such statement about risk and harm in the three November letters.
None of the three companies immediately responded to Bloomberg BNA's requests for comments.
The three companies may have been encouraged in their endeavors by the example of 23andMe, which received clearance in February to DTC market its genetic test for Bloom syndrome, a condition associated with short stature and higher cancer risks.
In October, 23andMe reinstituted over 60 health, ancestry, wellness and personal genetic trait reports, selling them DTC for $199.
But 23andMe was itself the subject of an FDA warning letter in December 2013, which forced the company to cancel its television and internet advertising and spend a year finding its way back into the FDA's good graces.
The FDA letters came during a period when the agency is expressing concern about the potential negative effect of unregulated or under-regulated tests on the public.
The agency is proposing to increase its oversight of laboratory-developed tests (LDTs), for which it has previously exercised “enforcement discretion.” The FDA's plan for more LDT oversight was prompted by a concern that these tests, which were once confined to a single laboratory, are now being more widely used in patients at multiple sites and without FDA review. A House hearing on diagnostic tests is set for Nov. 17.
But the emphasis in the three FDA letters was on direct-to-consumer marketing of tests without approval. The FDA noted in its letter to Interleukin that the company had written in response to a 2010 FDA communication in defense of its lack of marketing clearance for an Interleukin test that the test was an LDT. “It appears that at the present time your firm is offering these tests under a Direct-to-Consumer model,” the agency wrote.
Waltham, Mass.-based Interleukin sells tests to identify people with a genetic predisposition for increased risk of heart attack, diabetes, obesity or weight problems. The FDA specifically cited the company's PerioPredict Genetic Test, Osteoarthritis Genetic Test and Weight Management Genetic Test.
DNA4Life, which is based in Fairhope, Ala., sells the Pharmacogenetic Report, which is designed to predict how patients will respond to more than 120 of the most commonly prescribed medications. The test marketed by Lisle, Ill.-based DNA CardioCheck screens for DNA genetic markers associated with heart disease and stroke.
All three letters were similarly worded and signed by James L. Woods, deputy director for patient safety and product quality for the Office of In Vitro Diagnostics and Radiological Health, at the FDA's Center for Devices and Radiological Health. The letters asked the companies to either send the FDA evidence of FDA clearance or an explanation as to why they felt such clearance wasn't required.
To contact the reporter on this story: John T. Aquino in Washington at email@example.com
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The letter to DNA CardioCheck is at http://src.bna.com/0g.
The letter to DNA4Life is at http://src.bna.com/0h.
The letter to Interleukin is at http://src.bna.com/0f.
Additional FDA letters can be found at http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm.
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