New Yorker magazine carries an article (full text available to all) about a young self-made billionaire whose success was partly due to having put in the effort to learn Mandarin while in high school.
Separately, the article covers the question of whether people will benefit from being able to get blood tests more easily and cheaply, e.g., without having to first visit a physician and without having a vein opened up. A doctor friend says “Never order a test unless you know what you’re going to do with the answer.” If he is correct then generally we will not be healthier if we get more numbers more frequently. The article also covers the question of the extent to which the FDA will regulate vertically integrated blood testing labs differently than labs who buy their machines from third-party vendors.
Regarding the second question, I queried a friend in the pharma industry. Here’s what she had to say…
A couple of things struck me, the first being the powerful friends/supporters that she has on her Board. I really do believe that this has insulated her from some rather obvious scrutiny. The second was the FDA representatives who appear to not have a clue regarding their own regulations.
If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls.
A device is:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
This part of the CFR details the Quality System Requirements for all Medical Devices. In the scope section it states: “(a) Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” (Theranos is utilizing these devices for the diagnoses of human ailments, so this should be applicable.)
This section of the Code of Federal Regulations discusses exemptions for diagnostic devices, and specifically states: “…must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device…” and goes on to list circumstances and applications which appear to fit the description of this application.
I think the crux of the argument here is the interstate commerce clause, however the argument could certainly be made, and I think effectively, that because this device is being utilized as a diagnostic tool in multiple states, Theranos has definitely crossed the line into interstate commerce.