FDA Fired Device Whistleblowers
The Food and Drug Administration fired six device division reviewers after they complained to Congressional staffers that the agency was approving unsafe or inadequate medical devices. The charge? Leaking confidential business information. The evidence?
The Food and Drug Administration fired six device division reviewers after they complained to Congressional staffers that the agency was approving unsafe or inadequate medical devices. The charge? Leaking confidential business information. The evidence? Personal gmail-account emails viewed on government computers that the agency monitored without employee knowledge, the Washington Post reported this morning.
The six have filed suit for wrongful discharge, as well they should. While there were probably crucial details left out of a short newspaper story and probably unknown to the reporters, there seems little doubt that the actions and comments of the six scientists were driven by differing interpretation of scientific evidence behind the approval of new devices, several of which involved detecting cancer. Firing someone for bringing that to the attention of Capitol Hill staffers after the agency has moved in what they believed was the wrong direction would seem to be a direct violation of the nation’s whistleblower protection laws.
It’s doubly disturbing that the firings occurred in mid-2010 when the debates swirling around the agency involved the inadequacy of the scientific standards being applied to medical devices through its 510(k) process, where new devices can be approved without clinical trials because they are deemed almost the same as the device they are replacing in the marketplace. One has to wonder if these firings were connected to that debate, which remains unresolved.
You may be interested
7 Super Foods that Boost ImmunityAmy Trotter - Jun 22, 2017
If you are looking to shake the pesky colds and flus that make the colder months unbearable, look no further…
Causes and Consequences of Skin IrritationRehan Ijaz - Jun 21, 2017
Skin ailments are the most common health problem that Americans face. Unfortunately, even seemingly benign skin problems such as acne…
A Changing World: 4 Things that will Change Healthcare in the next 10 YearsKara Masterson - Jun 20, 2017
Obamacare and the possibility of significant repeal-and-replace plans have made the future of healthcare highly controversial subjects for many Americans.…