Back in June, the New York Times reported that state and federal regulators are starting to scrutinize a new industry: selling genetic test results directly to consumers:
“Regulators are cracking down on companies that sell genetic tests directly to consumers, threatening to crimp the growth of one of the hottest sectors of the biotechnology industry.”
Many of us might like to know if we’re genetically predisposed to developing diabetes, cancer, or maybe Alzheimer’s down the road, or whether our children or future offspring might be more at risk. An emerging group of companies can take saliva samples or other tissues and scan our genomes, looking for certain clues that we might be at risk to develop certain diseases.
But consumers and regulators have flagged several questions about this budding industry:
What are the standards for proving a genetic test is valid? Must a doctor always be involved in ordering such tests to protect patients, or is that an attempt by doctors to protect their turf?
Of course, the companies retort that
people have a right to know the information in their genes and to guide their own health care.
The major question seems to be who has jurisdiction to regulate this new field. As we discussed in our first two classes, this can be a tricky question. If these tests somehow constitute medical advice, state medical boards would likely have jurisdiction.
So far, the state Departments of Health in New York and California have sent cease-and-desist letters to gene testing companies, saying they need to be licensed. A federal advisory committee said these companies need to be regulated because they can do harm to patients. The FTC is investigating, and the U.S. Senate is investigating. The labs themselves are regulated by the Centers for Medicare and Medicaid Services (CMS), a federal agency. What about the FDA?
So, should the government regulate this new industry? If so, what should it do? And should responsibility for this new industry lay with the federal government or states? Which agency?
If we shouldn’t regulate yet, why not?
UPDATE: Google founder announces that he has a gene that gives him a greater chance of developing Parkinson’s. His wife founded one of these gene testing companies, 23andMe.com.