The FDA has been trying to decide how to regulate direct-to-consumer genetic tests in America. These tests, sold by companies like Ancestry and 23andMe sequence the customer’s DNA and provide detailed reports on ancestry and health traits.
In 2011, one of these FDA meetings appeared to agree that health-related genomic tests needed to be conducted through a licensed physician. They also seemed to agree that the results needed to be communicated by a physician.
It is important to remember that the FDA has not legislated on DTC genetic tests. They only review tests if they claim to provide information about moderate to high-risk medical conditions.
These tests are reviewed to ascertain whether they can reliably do what they claim to do and whether their measurements can indicate a medical condition.
The FDA also checks what the company says about its tests to ensure it lines up with what they can deliver.
Undeniably, there needs to be some sort of regulation of DTC genetic tests. However, this is a complex issue and there is a wide range of opinions about how best to regulate fairly.
There are a few points that people within the genomic community seem to agree on:
- People have a right to access information, including genetic information, about themselves - This is a fundamental right that should guide any and all policy decisions. It doesn’t deny the importance of accurate communication, interpretation, and test validity, but it does supersede it.
- DTC tests don’t put customers at risk - The physical risks of DTC tests are non-existent. The biggest risk is getting a paper cut when opening the box. The psychological risks are what we are concerned about. However, a study of 2000 participants established that testing didn’t create short term psychological damage. With this in mind, it is hard to justify restrictions that would prevent individual customers from accessing their genetic information.
- DNA shouldn’t be treated differently just because it’s DNA - The idea that genetics have to be treated differently by law is a bias that has no place in policymaking. Instead, tests should be judged based on their utility, potential, and relative harms.
- DNA sequencing is becoming cheaper and as it does so, medical and non-medical testing will become increasingly blurred - regulating health-related genetic tests will cause problems for people who are trying to use genome sequencing for things like genealogy.
- Most physicians don’t have the training to read and interpret genomic tests - While we appreciate that the FDA wants to make sure that professionals read and communicate important health information to consumers, physicians are not the people to do this. A genetic counselor would be a more appropriate choice.
- Informed individuals are able to interpret results - underestimating the individual consumers is a mistake and an insult. It does not need to happen.
The FDA, as we said, have not created legislation or regulations for DTC tests. Presumably, if they do, they will be met with a lot of lobbying and protest if the legislation is excessive.
The worst outcome of any legislation will be the extermination of DTC testing companies and the genomic market as a whole.
We’re not saying that there should be no legislation. We argue for a measured approach that focuses on enforcing accuracy, punishing unsubstantiated claims, and encouraging consumer information.