The Agency prefers a risk-adverse approach that typically places patient safety above innovation...
The FDA order against 23andMe to stop genetic testing shows that in the balance between regulation and innovation the FDA occasionally must address an age old debate.
The Warning Letter should be no surprise to anyone familiar with the FDA’s history on medical devices or genetic testing. The Agency prefers a risk-adverse approach that typically places patient safety above innovation. Critics will point to the advancements made in Europe through the easier CE marking process as evidence of innovation leading regulation. The FDA will, as it did in the wake of the PIP breast implant scandal and others, point to instances where a CE cleared devices was later recalled because of safety concerns raised after approval.
Yet, in the 23andMe instance we are talking about something entirely different. It’s not a matter of innovation hampered by regulation, but a company entering the market before they cleared the mundane regulatory hurdles common to all medical device companies. 23andMe failed to gain pre-market clearance by demonstrating their product was effective for its intended use. The FDA’s reluctance to green-light genetic tests is well known and debated and requires delicate maneuvering. Genetic testing has been a subject of heated debate for the past three years. The FDA began reexamining its approach to laboratory developed genetic tests (LDTs) in 2010 issuing several warning letters but taking no action. Its prior position was that LDTs were medical devices, not a medical service, but it chose to exercise enforcement discretion. The Agency separately addressed at home genetic tests ultimately deciding the interpretation of the results was better left in the hands of doctors rather than patients.
In the end this is not as much about innovation versus regulation, but about a company, not unlike most, seeking to enter the market quickly. In doing so it ignored the basic definition of a medical device and was caught off guard by the pre-market approval process.
[Marc C. Sanchez represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. He also teaches as part-time adjunct professor at Northeastern University on regulatory topics including US and international food law and regulation.
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