The FDA has decided that allowing people to spit on swab and put it in the mail is a danger to society. The company 23andMe, which allows customers to send samples of their saliva to have their genome sequenced, has been sent a warning letter by FDA and has now been banned from processing anymore of these home genetics tests. Because 23andMe hasn’t gone through the testing required by the Food, Drug, and Cosmetic Act of 1938, the FDA sees fit to stop the company’s operations, even though no one has been harmed by participating these home tests.
In fact, in their letter the FDA doesn’t seem to find an example of anyone getting so much as a papercut off of these home testing kits. However, because it’s a device intended for the “diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease” and has not officially been given a seal of approval by FDA, 23andMe is no longer allowed to operate.
While 23andMe’s genetic test don’t seem to fall under the traditional definition for medical testing, the FDA is still afraid that customers who receive the results of this home test will attempt to treat this diagnosis without seeking more medical advice. The FDA seems to think that the type of person who would seek out the makeup of their own genome is the type of person who would try to self-medicate for a slim chance they might be genetically predisposed to it. In fact, the type of person who is concerned about their genetic predispositions and makeup seems to be the type of responsible person who is more likely to seek more tests and medical advice.
The example the FDA uses that they seem to be so terrified of people trying to self-medicate and cure is the fact that 23andMe’s genetic sequencing can pick out if particular women carry BRCA, the gene that determines predisposition to ovarian or breast cancer. Considering that some of the best ways of cutting your risk of breast cancer are simple everyday things such as getting regular exercise and not smoking, what exactly is the FDA afraid of? Yes, celebrities who have been diagnosed with this gene such as Angelina Jolie have taken somewhat extreme steps and have had double mastectomies performed, but is the FDA really afraid of women performing self-mastectomies?
Or maybe instead, most rational women concerned about their health would make sure to mitigate their risk by living a healthy lifestyle and seeing a doctor on a regular basis. When comes to health, the more reliable the knowledge the better. And the more information a patient is able to provide to a doctor, the more likely a successful, individual treatment plan can be devised. Publicly accessible genetic testing (23andMe testing kits sell for only $99) would, if anything, allow patients to live healthy lives and be able to seek treatments that work for them individually.
This warning letter merely shows business owners and consumers that the FDA needs to modernize and quickly. The FDA’s rules and regulations have started to show their age and it isn’t pretty. The Food, Drug, and Cosmetic Act, signed into law in 1938, needs to be updated to account for new technologies such as home genetic testing.
When this particular bill had been signed into law, the DNA molecule wouldn’t be officially discovered for another 21 years when Watson and Crick discovered the double helix. The full human genome wasn’t even fully sequenced until 2003, a full 70 years after this act was passed. Through this warning letter, the FDA is stopping major progress in genetic technology becoming easily and cheaply accessible to the public.The FDA needs update their rules and regulations for a new century and new technology, or be guilty of holding back medical and scientific progress and endangering people’s lives.
