Is FDA’s Crackdown on Direct-to-Consumer Genetic Testing a Violation of the First Amendment?

Newswise — WASHINGTON – In November 2013, the U.S. Food and Drug Administration (FDA) ordered the company 23andMe to stop offering its direct-to-consumer DNA testing service, which provided individuals with $99 assessments of their genetic risk for almost 200 disorders. A thought-stimulating opinion piece published in Clinical Chemistry, the journal of AACC, now examines whether this move by FDA is a violation of the First Amendment, or a necessary step to protect consumers.

23andMe seemingly made it easy for individuals to decode their own genome without having to go through a physician. Using a kit the company provided, an interested individual mailed in a saliva sample that got analyzed by 23andMe for a broad spectrum of genes and mutations. Many initially hailed this Personal Genome Service (PGS), as 23andMe called it, as a medical revolution. It gave people direct access to critical information about their health risks while allowing them to contribute to a genetic database that could serve as a valuable resource for medical researchers. When the company failed to provide FDA with evidence of the PGS test’s validity, though, the agency shut down the operation in order to protect consumers from receiving invalid test results that could lead people to seek unnecessary—or not seek necessary—medical treatment.

Some critics of this decision are arguing that the agency is disallowing advertising (“commercial speech”) as well as interfering with an individual’s right to receive information, both of which are protected under the First Amendment. In this opinion piece, Linnea M. Baudhuin, PhD, of the Mayo Clinic, Rochester, Minn., takes a closer look at the shortcomings of the PGS test and why the information it provides might be more aptly considered misinformation.

One of Baudhuin’s main critiques of 23andMe’s test is that it is not a comprehensive genetic analysis, a limitation about which many consumers are not aware. Though many medical conditions might be associated with a long list of pathogenic mutations, sometimes numbering in the thousands, the PGS test only detects a small percentage of these. This means the test could determine that a woman is at low risk for breast cancer, for example, even though she carries one of the cancer-causing variants of the BRCA1 and BRCA2 genes.

Furthermore, even if a patient were to ask his doctor for advice regarding his PGS test results, because of the rapid explosion of genetic testing, an alarming 85% of primary care physicians do not feel prepared to interpret genetic risk data and would be of little help.

“Direct-to-consumer companies should have a sense of responsibility to provide tests that are only clinically valid and can be used in ways to provide information about diagnosis, treatment, management, or prevention of a disorder,” said Baudhuin. “Including a large group of incomplete and/or meaningless tests with unvalidated risk calculations confuses the consumer, demeans the overall test, and contributes to wasted healthcare time and money.”

________________________________________About AACCDedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

Clinical Chemistry is the leading international journal of clinical laboratory science, providing 2,000 pages per year of peer-reviewed papers that advance the science of the field. With an impact factor of 7.1, Clinical Chemistry covers everything from molecular diagnostics to laboratory management.