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WayneBGood's avatar

They are not legally notified unless you send them the email printed, certified and return receipt requested.

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A Midwestern Doctor's avatar

I am presently working on compiling a summary of all the FDA's major regulatory failures with the COVID vaccines (largely from Peter Doshi's work), and in the process I discovered that the exact same thing happened with the antidepressants (they have minimal efficacy, they often caused people to turn psychotic which at times results in suicides and homicides), and the FDA nonetheless approved these drugs because the president at the time, George HW Bush was in bed with Prozac's manufacturer.

As a result, the FDA ignored numerous serious data integrity concerns and clear signs of significant harm from the drugs. Instead of addressing this, they did everything they could to conceal and suppress safety concerns of the SSRIs, and it took over 20 years for them to have a basic admission of some of the basic issues with these drugs, all of which only occurred due to numerous court cases forcing the manufacturers to reveal incriminating private company documents, leaks of internal FDA documents showing the FDA was deliberately concealing the harm from these drugs, congressional and Senate hearings on the topic and the media being willing to discuss these issues. As I am sure you know, none of this has happened for the Covid vaccines.

It has now been over three decades of these drugs being on the market, many people have been severely harmed by them (including many of your readers and my own), and nothing has really been done besides give the drug's a black box warning most prescribers ignore.

If anyone is interested, I tried to summarize what happened here. As far as I know it's the best prototype for understanding the FDA is atrocious behavior with the Covid vaccines:

https://amidwesterndoctor.substack.com/p/how-the-fda-buried-the-dangers-of?s=w

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