This bill, S.2388, introduced in the U.S. Senate by Senators Ted Cruz (R-TX) and Mike Lee (R-UT) on 12/10/2015, has been referred to the Committee on Health, Education, Labor, and Pensions (HELP).
Its stated purpose is “To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.”
Essentially what this Act would provide is that if a drug, biological product, or device is approved for use in another country, then the U.S. Food and Drug Administration (FDA) would approve it for use in the United States without it having to go through the entire FDA approval process.
While we applaud the Senators for desiring to reduce the inherent bureaucracy of the FDA, we cannot help but notice that this would open the door for marketing various harmful psychiatric drugs and devices without satisfying the usual FDA requirements for safety and effectiveness.
The Act also authorizes an outreach campaign to encourage the sponsors of such products that are potentially eligible for reciprocal marketing approval to request such approval.
We think this Act deserves to be amended to explicitly exclude psychiatric drugs, and devices such as transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation, or any other electric shock or magnetic wave device designed to interfere with the brain.
Please contact your U.S. Senator and the members of HELP to express your viewpoint regarding S.2388.