A person in Cambridge, Mass., filed a petition on Nov. 25 with the White House to “overrule” the FDA’s warning letter to 23andMe, which demands the company halt sales of its genetic testing spit kits.
Registered under healthcare, space and science policy and regulatory reform, the petition reads:
WE PETITION THE OBAMA ADMINISTRATION TO:
overrule the FDA’s decision to bar 23andMe from selling their potentially life-saving diagnostic kits.
We, the healthcare consumers of America, demand that we maintain access to genomics testing services like 23andMe’s, which serve as a 100% privately purchased complement to government-regulated healthcare.
The FDA grossly overstates the risks associated with 23andMe’s assessments. Statements such as those suggesting that dangers like false positives may “lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions” are outrageous and patently false.
Risks associated with services like 23andMe’s are understood by private consumers, while the benefits of these services (such as early diagnoses for chronic diseases) are significant. The price of over-regulation is lengthy delays in potentially life-saving medical innovations.
Reducing Clinical and Staff Burnout with AI Automation
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
At the time of this posting, the petition has 1,828 of the necessary 100,000. That number must be reached by Dec. 25 to receive some sort of official response from the Obama administration.
To view or sign the petition, click here.
To read about the controversy in the science community, click here.
Follow MedCity News on Facebook and Twitter for more updates.