FDA and DEA Opioid Crisis Defenses Under Fire: A Review

Added: 2026-05-31

[00:00:00]Hey everybody, Dr. Doug Smith here. We have now finished our initial review of the three rules that were in place to protect the citizens from an opioid crisis ever happening and how each of those were breached. We started with the 80/20 rule, we then went to the annual production quota, and then we finished up with the standard of care issued by the FDA in its product information.

[00:00:18]Before we move on further, let's take a look exactly where we are. The breaching of the DEA 80/20 rule, okay, we now have in this country what looks like to be about 3 million pounds medically unnecessary narcotic raw material. to exactly estimate it because on page 6,846 of the Federal Register, all of a sudden they stop talking about the weight of narcotic raw material and they start talking about the weight of thebaine and I have a hard time believing that's by accident. And we're talking about this massive inflow of narcotic raw material coming into the country from Australia, from the island of Tasmania. Let's look at a couple of quotes coming out of Australia. We begin with this saver right here written by Anthony J. Fisk.

[00:00:54]Now, who in the world is Anthony J.

[00:00:56]Fisk? That's the person that did the patent on the genetically modified poppy plant that made no morphine and only made thebaine. In fact, for his work, Fisk received the Johnson Medal, the highest honor given out by Johnson & Johnson in the year 2000. Let's read exactly what he had to say about this.

[00:01:11]And we see right here, it says, "Imports are not restricted." Now, he's referring to the 80/20 rule. Now, remember, the 80/20 rule was there to prevent medically unnecessary narcotic raw material from ever entering the country and for Anthony J. Fisk there on the island of Tasmania to say "Imports are not restricted." Where was that said?

[00:01:26]Who said that? I cannot find a counterpart here in the United States where any such words were ever said or issued, okay? And then remember the newspaper article that we saw there on the island of Tasmania. It said, and I quote, "Tasmania's $200 million poppy industry has been given unlimited access to the United States." Who told them that? And again, I can't find a comparable quote here in the United States. I can't find anything like that in the Federal Register other than footnote five. And before we leave this subject, let's look at one last quote.

[00:01:53]This one again in the Washington Post and it's from Sabrina Frome, who is an attorney speaking on behalf of Johnson & Johnson. And let me read this quote.

[00:01:59]"Thebaine is not subject to the rule and for good reason. Unlike morphine, codeine, and some other alkaloids, thebaine is not abusable in its raw form because it's poisonous." End of quote.

[00:02:08]Okay, we're talking about the 80/20 rule here, okay? And there was nothing about the 80/20 rule that had anything to do with whether or not narcotic raw material was poisonous or could be diverted. The whole point of the 80/20 rule was to prevent medically unnecessary narcotic raw material from ever entering the country. But Johnson & Johnson's another one on the book with their position that thebaine is not subject to the rule. And their reasoning for it is very shaky. Thebaine is not abusable. That had nothing to do with the 80/20 rule. And quite frankly, I'm not sure that quote actually helps Johnson & Johnson. But it's interesting.

[00:02:38]Okay, so that covers where we are on the 80/20 rule. Let's move on now to the second of the DEA rules that was breached. And that was the APQ, the annual production quota. And metaphorically speaking now, we now have 3 million pounds of medically unnecessary narcotic raw material which turned into 1 million kilos of medically unnecessary, mostly oxycodone here in this country. And now, as we saw, the FDA has reached the standard of care with the product information that took the daily maximum of oxycodone from a very reasonable 60 mg a day to an unreasonable 320 mg a day. Let's put that in perspective. Now, a bottle with 60 tablets in it contains the same amount of oxycodone that was in 1,000 tablets of the Percocet 10. And remember the letter that we reviewed from Dr. Janet Woodcock to Senator Grassley and there on page three it said, "Additional novel efficacy studies were not necessary." End of quote. You went from giving people 60 mg a day maximum of oxycodone to 320 mg a day. You're now giving them the equivalent of a bottle of 1,000 Percocet 10s a month. And you're saying that additional novel efficacy studies were not necessary.

[00:03:34]That's the definition of bureaucratic incompetence, okay? And physicians were fooled by it. They trusted the FDA. The FDA betrayed us by leveraging the trust.

[00:03:41]We trusted that the FDA fully tested anything that went into the package insert. But what we're seeing here now is that in essence what the FDA did was made guinea pigs out of the US citizens.

[00:03:50]When the FDA made guinea pigs out of the US citizens, they ran into Mother Nature. It's known as the rule of toxicology. And yes, it's a very complex looking equation, but let me make it real simple for you. When exposure to a toxin becomes continuous, 24/7, really bad things happen. When the FDA took the maximum daily dosage of oxycodone from a reasonable 60 mg a day to an unreasonable 320 mg a day, what they did was make the exposure to the toxic substance now 24/7. All right, everybody, we're going to hold here for today. Everybody have a wonderful afternoon. Don't forget to like and subscribe to us. Don't forget to post this podcast on your social media, everybody else's social media, and we will see y'all back. Bye-bye.