View Full Version : FDA's problem with testing cos

03-09-10, 18:26
Now that the FDA has expressed suspicion towards genetic testing companies, does it make you more skeptical about your results or the prospect of testing?

I know many here are not in the US, but it seems relevant either way to have any govt agency take this stance. Personally, I'm now rethinking getting the full test with 23andme. If MDs don't count it as useful, then how reassuring can it be? The FDA claims to have found: inaccurate and fraudulent testing, exaggerated medical claims, etc etc. And 23andme is included in their list of problem companies. This is quite disappointing, as I was really excited about getting this information. Then again, the FDA is not the sole or ultimate authority, so I'm not even sure how seriously to take their position here.

Now that they are supposedly working on regulation, how long will it be? As a US govt agency, FDA isn't exactly the fastest thing in the world. :/

03-09-10, 22:20
Interesting. How come FDA has a jurisdiction over testing companies? They don't produce drugs, medical equipment to cure people, they don't advise people how to medicate themselves. It's just reading of persons DNA.
FDA should be more concerned about palm readings, supplement industry etc, advising people or medicating them, without any proof that it works. Now that's harmful.
On other hand I wouldn't mind sending few inspectors from time to time, checking if testing companies or supplement producers are honest, and their products contain what's on the label. Otherwise what's left is the law, lawsuits, class action, and free market weeding out bad business. Eve though it works it takes way too long and it's more costly for both parties. Inspections and government overseeing is not a bad idea, but it creates big inefficient bureaucracy and it's open to corruption too.
Ah, that's life, never a perfect solution available. lol

04-09-10, 06:13
Well as much as I hate to agree with LeBrok (since lynx will think I am in collusion with you) I would like to see some sort of inspecting body that oversaw the testing procedures and insured that there was some validity to the results.
I agree on another issue I'm not sure I want the FDA to get involved in this process, I have a basic distrust of the FDA and their nonsensical policies.

04-09-10, 08:57
The FDA claims they have authority over this because the companies advertise results as a medical tool. Not all genetic tests are "medical tools" of course. It's just that many include health information, which may "falsely scare or falsely reassure" people about their health risks. This means that people may make decisions about their health with that information in mind, which makes the test a medical tool, which comes back to the FDA.

They've given me a lot of doubt about testing. I guess it's better to know than get misleading results and not know it. I agree that regulation is a good idea. I'm just concerned about a) the quality of said regulation and b) the time it would take to get any concrete results from the FDA