Monday, September 25, 2023

Regulatory Capture and the Pharmaceutical Industry


I was leafing through a book and discovered an article from 2008 that I had cut out and saved in its pages. The article is salient to the problem of regulatory capture, which I've written about extensively - e.g., see here

In the article excerpted below, FDA employees were challenging their organization's stance that agency drug labels pre-empt state laws, thereby blocking consumer lawsuits against hazardous drugs:

Mundy, Alicia (2008, October 30). FDA Memos Undercut Stance on Pre-Empting Drug Suits. The Wall Street Journal, p. A3.

Career officials at the Food and Drug Administration objected to the FDA blocking consumer lawsuits against drug makers in the past few years, according to agency documents released Wednesday in a congressional investigation.

...The FDA wants the high court to pre-empt lawsuits in state court over problems with federally regulated drugs.

Two officials said in the memos it is wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

'Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approving labeling is fully accurate and up-to-date in a real time base,' wrote John Jenkins, the top official in the drug approval section, in 2003. At that time, the FDA was debating a rule, later adopted, that enshrined the concept of pre-empting state suits....  

The current debacle with the mRNA vaccine hazards illustrates regulatory capture by corporate interests at an unprecedented scale, as I discuss here. For example, a recent article provides evidence that the FDA accelerated mRNA vaccine approval in order to enable vaccine mandates. 

Whistleblowers within FDA and other organizations involved in testing and approval processes spoke up but they were steamrolled, marginalized, expelled and dismissed. See here:

The machine that is the FDA/CDC complex tolerates no dissent under conditions of regulatory capture.

Furthermore, as illustrated by the unethical mandates, we have entered a new era where regulatory capture not only greases approval of products with undetermined safety issues, but also requires populations to be subjected to them, regardless of their need or willingness.

As I posted recently, we have entered an era of Pay to Play on Pharmed Humans.

People are waking up to this travesty of justice but institutional change demands (peaceful) institutional accountability starting with full transparency.


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