Tag: FDA approval

The illusions of “right to try” laws

[Ed. Note: For additional commentary on why “right-to-try” laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.] There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside...

/ March 6, 2014

Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

Electrodermal testing is a bogus procedure where measurements of skin conductance with a biofeedback device are entered into a computer to diagnose nonexistent health problems and “energy imbalances” and to recommend treatments for them, often involving the sale of homeopathic remedies and other useless products. It falls under the general category of EAV (Electro Acupuncture of Voll). The history and variants of...

/ March 5, 2013

Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things. Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require...

/ July 12, 2011