FDA Wants To Regulate Genetic Testing

Randall Parker's FuturePundit is a great blog, and he recently posted that the FDA Wants To Regulate Genetic Testing:

The FDA wants to get more involved in controlling the genetic testing industry.

In a prelude to overhauling its regulatory oversight of genetic diagnostic testing, the U.S. Food and Drug Administration will convene a public meeting next week to gather input from test makers and others.

The event reflects a turning point in genetic testing, a cornerstone of personalized medicine. Once mainly the domain of rare diseases, scientists have discovered a growing number of genetic variations linked to both the risk of more common disease and patients' response to drugs. The number of genetic diagnostic tests has expanded rapidly, and tests have become increasingly complex, making it more challenging to interpret and act on the results.

Randall notes: "I would prefer the FDA and like regulatory agencies stay out of genetic testing except perhaps to test for error rates and publish the results. The rate of innovation will be faster with less regulatory involvement."

What do you think?  Please post a comment...

Comments

[Dennis (Investigator/Negotiator) at Medical BillDog]

Regulation, yes. FDA regulation, no.

Genetic testing offers too many opportunities for abuse and bunco. We need an official agency to ensure they're doing what they're supposed to do. That shouldn't prevent honest companies from providing honest results, including clear explanations of what the testing really can and can't tell you.

Why not FDA? First, genetic testing is not a consumable--it's neither food nor drug. Second, they're too damned ponderous and slow. FDA processes are bloated and in desperate need of streamlining and revision. Let's not add yet another branch of biomed to their purview (and slow them down just that much more). I suggest that we have enough genetic manipulation and genetic testing concerns to warrant a new organization, perhaps a subsidiary of HHS.