Gardner Harris
๐ค SpeakerAppearances Over Time
Podcast Appearances
So there was something called the drug lag.
And these new drugs were coming out in Europe before the United States, which was causing FDA all kinds of political problems.
And Republicans in Congress were starting to say, we should...
get private contractors to do these approvals because FDA can't get it done.
So FDA in 1992 struck a deal with drug makers in which drug makers basically started paying the FDA for its reviews.
And at this point, the vast majority of FDA's budget is paid for through these industry fees.
And as payback, basically FDA put its criminal investigators
in a lockbox and wouldn't let them out.
And so FDA, from 1992 onward, basically never launches another criminal investigation of drug makers ever again.
Basically, they leave the policing of the industry alone.
And even though the FDA knows exactly what's going on, because they still have people looking at
the marketing materials of many of these companies and realizing that many of these marketing materials are completely misleading and are frank lies.
And they often send warning letters to Johnson & Johnson like,
You're saying things that are not true, but they never let their own police officers out.
And so this is the story of the opioid crisis, which is that the FDA basically let it happen on its watch.
And the opioid crisis ballooned because companies like Johnson & Johnson and Purdue Pharma sold opioids as safe and non-addictive when they knew that that was not true.
And the FDA did nothing about it because by then the FDA had been bought and paid for.
So Johnson & Johnson has agreed to a settlement.
The opioid litigation continues on.
There's been an enormous back and forth between cities, counties, and others in trying to put together a sort of global settlement amongst Purdue Pharma, which of course, as you know, has declared bankruptcy, Malincrot, another maker of opioids, and Johnson & Johnson.