- Under FDA,countless products used to cull/convey clinical info are "medical devices" that may not be sold w/o advance approval.
- FDA attempts to protect us from the perils of scrutinizing ourselves may also be unconstitutional.
- FDA typically takes mos./yrs to review license apps, so licensing will keep us well behind up-to-date medical science.
Some years ago, the Food and Drug Administration launched a secretive project to review and approve medical journals.
FDA doesn't have authority to control the journals, but asserts that its authority to regulate the label that accompanies medical products extends to any information that manufacturers distribute to doctors or consumers. FDA planned to develop criteria for rating journals based on the rigor of their peer review process, and use these standards to decide which articles would be eligible for distribution.
FDA has always had trouble reconciling the free flow of truthful, non-misleading scientific information with the agency's impulse to tightly control how clinical information is presented to, and interpreted by, patients and providers.
That conflict was on display recently in the unprecedented letter that FDA sent to the gene testing firm 23andMe. Invoking FDA's statutory authority to regulate diagnostic "devices" the letter ordered the company to stop marketing a genetic test kit that's sold directly to consumers.
23andme has since been hit with a class action lawsuit.
Users of the 23andMe test mail a sample of spit to the company's lab in Southern California. The lab is federally and state certified to reliably perform "high complexity" tests. It extracts DNA from cells in the saliva and analyzes it for genes that have been associated with about 250 different disorders.
23andMe doesn't diagnose current health or recommend treatments. Instead, it links customers to information derived from published, peer reviewed, scientific studies of how those genes correlate with certain health risks, and uses those same sources to provide estimates of the customer's risk of developing various disorders.
That's the part that bothers FDA - not the test's accuracy, but what FDA views as "unsupported" clinical interpretations of the data by providers or medically unwise responses to the information by consumers. If 23andMe provided only the genetic data and left it you and Google to interpret the results all would apparently be fine.
This posture puts FDA on a collision course with a rapidly growing array of search engines, I-Phone apps, and social media. These tools help connect patients with sources of reliable clinical information and hold great promise for improving health.
Under FDA's evolving constructs, countless products that are used to cull or convey clinical information are "medical devices" that may not be sold without the agency's advance approval. Seeing this, people developing these tools are actively trying to dodge FDA by deliberately dumbing down their products.
With 23andMe, as with similar medical apps, software, and even web sites, FDA says its main concern is improper patient responses to the information supplied.
"Doctors do a lot of double mastectomies because of fear" patients have about their genetic risk of breast cancer. So says the head of the FDA group that regulates these tests, in defending his action against 23andMe. On the margins, some patients may indeed overreact to information that's not well understood. But extrapolating from anecdotal impressions to prescribe sweeping regulatory rules is careless.
It's also unscientific. How patients and doctors react to diagnostic information depends on everything else that shapes their thoughts about disease, medicine, and life, including nonmedical interests in cost, convenience, privacy, and autonomy.
FDA can't objectively weigh and balance these factors even in the short term, and can't possibly anticipate how that balance will shift as the convergence of the biochemical and digital revolutions democratizes access to floods of new biochemical data. New science linking molecular causes to clinical effects emerges daily. FDA typically takes months or years to review license applications, so licensing will keep us well behind the most up-to-date medical science.
FDA attempts to protect us from the perils of scrutinizing ourselves may also be unconstitutional. The agency is trying to regulate mental responses to the data supplied by the tests - how others interpret or decide to act on accurate science.
The Supreme Court has repeatedly concluded that freedom of speech includes a private right to listen, read, and study that's even broader than the right to speak, write, and teach. Enabling tools and technology-the printing press and ink that produce the newspaper, for example-enjoy the same constitutional protection. Dodging the First Amendment requires more than loose speculation about the possibility that the molecular scripts of life are too subtle and important to be read with impunity by the masses.
Licensing schemes like FDA's are ordinarily reserved for high-risk products. Most other products in commerce are regulated, if at all, by government rules addressing reliability and self-testing. These require only that products be built to meet specifications for how they perform. Congress should consider a similar method when it comes to new tech medical information tools like consumer gene tests, medical apps, and clinical decision software.
Software for managing electronic health records is already being regulated this way. Policy makers were persuaded to adopt a more modest regulatory scheme to save these promising tools from paralytic FDA oversight. Congress should do the same for the burgeoning array of novel tools that help individuals interpret information about their own health and make personal decisions about how to act on it.