Just the News No Noise with John Solomon and Amanada Head, January 1st, 2025

Summary

Podcast Summary: Real America’s Voice – "Just the News No Noise"

Hosts: John Solomon & Amanda Head

Airdate: January 1, 2026

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Episode Overview

The episode launches the new year with an in-depth investigation into America’s pharmaceutical supply chain vulnerability, the push to restore domestic drug manufacturing, and the intertwined issues of national security, foreign dependency, and legislative bottlenecks. Featuring interviews with Senator Tommy Tuberville, retired Army Colonel Vic Suarez, Oxford Pharmaceuticals’ Tom Neely, and Argentum’s David Shook, the episode dissects obstacles, proposed solutions, and the urgent national necessity of securing drug supply for both civilians and service members.

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Key Discussion Points & Insights

1. The National Security Risk of Pharmaceutical Dependency

• Amanda kicks off by framing drug supply vulnerability as a critical national security issue, particularly concerning essential generics (antibiotics, medications for chronic/acute illness). (00:55)
• John & Amanda emphasize the COVID-era revelation: the U.S. is “too reliant on China and India” for the ingredients and finished forms of most generic drugs. (11:47)

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2. Interview with Senator Tommy Tuberville (Alabama)

Topics: Fentanyl, Drug Boat Policy, Islamic Terror Threats, Health Care Reform, Reshoring Pharmaceutical Manufacturing

a. Border Security & Drug Boat Policy

• Sen. Tuberville highlights a shift in federal policy: “They’ve been blowing these boats out of the water in the Caribbean and on the eastern side of the Pacific…” referring to drug trafficking vessels.
  Quote: “We’ve heard there’s a war on drugs. There’s not a war on drugs until the President of the United States said, this is going to stop. And he...told the Secretary of War, ‘I want this over with.’” (02:33)
• He links these interdictions not only to drug supply reduction, but as counter-terrorism, alleging Venezuela is the “capital of Central America for terrorism.”
• Predicts Democratic legislation would pivot toward impeachment if the House majority shifts.
  Quote: “If they were to win the House next year, it will be a full two years of impeachment processes. The American people will be the ones that suffered.” (04:02)

b. Domestic Security & Islamism

• Cites Europe’s struggles, warning of similar infiltration in the U.S.
  Quote: “London has fallen to...Islamic terrorists. Well, you know who else has fallen is France.” (05:35)
• Calls for Muslim Americans who “believe in our Constitution” to join in denouncing extremist ideology.
  Quote: “I need you to step up and speak with me to the radical Muslims saying enough’s enough; if you don’t believe in this country, go home.” (05:35)

c. Campus Safety

• Discusses the killing of Ella Cook (Brown University), decrying an uptick in violence against young conservatives. (08:17)

d. Health Care & Pharmaceutical Supply

• On Obamacare: Calls it a “disaster”; blames unaffordability, rural hospital closures, and provider attrition on the law.
  Quote: “If we can’t come up with a plan to fix Obamacare, it’s not the Democrats’ fault...it is the Republicans’ fault.” (10:32)
• On Reshoring Drugs: Touts an Eli Lilly facility in Huntsville, Alabama, as a positive sign. Laments four years of inaction under Biden; says Trump is “pushing the narrative” for domestic manufacturing.
  Quote: “We cannot live off Chinese and India pharmaceuticals. We have to be self-sufficient.” (12:14)

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3. Interview with Vic Suarez (Blue Zone Bioscience)

Topics: Military Drug Supply, Government Procurement, Policy Loopholes

a. Military Drug Safety Risks

• Suarez warns: U.S. military and V.A. depend on “repackager” companies exploiting loopholes to import low-cost, lower-quality drugs under the guise of “made in America.” (17:11, 20:45) Quote: “They found a way to disproportionately gain market share selling it to the federal government...dependent on these repackager companies.” (20:45)

b. Regulatory Loopholes

• Explains 2020 court ruling allows drugs with Chinese/Indian ingredients to be classified as U.S.-made if “substantially transformed” in the U.S.—mainly via packaging, not actual manufacturing. (20:45)
• Urges move from “lowest price, technically acceptable” procurement to “best value,” factoring resiliency and domestic quality. (23:22–24:35)

c. Barriers to U.S. Drug Manufacturing

• U.S. companies struggle to compete; even the few domestic manufacturers can’t gain market share against undercut foreign ingredients, despite congressional testimony. (25:00)

d. Timeline for Change

• Cautiously optimistic: achieving “irreversible momentum” in reshoring supply will be a 3–5 year process; “about a decade” for full reversal of dependency. (46:05)

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4. Interview with Tom Neely (Oxford Pharmaceuticals)

Topics: Generic Drug Market, Ingredient Sourcing, Regulatory Barriers

a. Market Realities

• “90% of the prescriptions...are generic drugs.” Drugs sold at “a penny and a half” per dose, creating little margin for domestic manufacturers. (30:43)
• Points out quality gaps: China controls 90% of the world’s API (active pharmaceutical ingredient) market; India makes 55% of the world’s generics—with “no checks and balances” after export. (30:43–33:26)

b. Regulatory/Permitting Challenge

• Notes changes: Alabama gets $6B Eli Lilly API plant—“we need more Oxfords” (American generics). Calls for Commerce Department “section 232” national security investigation for faster executive action. (33:26–36:36)
• Welcomes competition from other domestic manufacturers for national security reasons.

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5. Interview with David Shook (Argentum Pharmaceuticals)

Topics: True Domestic Manufacturing, Supply Chain Risk, Procurement Reform

a. Hollowing Out U.S. Generic Drug Industry

• Praises “major announcements” by Trump administration, but cautions that big brand pharma is unconnected to generic supply crisis. APIs, key starting materials, and finished generics overwhelmingly come from China and India. (37:57)
• U.S.-“made” forms are often just repackaged imports. (41:37)

b. Risk of Supply Disruption

• “Many of these drugs...effectively 16 week supply”—a few months at best—leaving the U.S. highly vulnerable to foreign supply shocks, quality recalls, or political disputes. (43:22)

c. The Procurement Problem

• Industry is dictated by absolute lowest cost, stifling domestic competition under current rules. (39:37–41:20)

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6. Final Recap with Vic Suarez

• Predicts positive momentum but not full resolution within one year; 3–5 years for significant irreversible change. (46:05)
• Main obstacle is “uneven playing field”—American firms face much higher regulatory scrutiny, increasing costs. Calls for government procurement reform to favor truly domestic manufacturers and correct loopholes. (47:34–49:40)

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Notable Quotes & Moments

• Sen. Tuberville:
  “We’ve heard there’s a war on drugs. There’s not a war on drugs until the President of the United States said, this is going to stop.” (02:33)
• Vic Suarez:
  “[China and India] found a way to disproportionately gain market share selling it to the federal government...dependent on these repackager companies.” (20:45)
• Tom Neely:
  “We sell 100 doses for $1.50...when it goes through the system and Medicare reimburses..., they reimburse to the insurance company, on average, $13.25. There should be a lot of reform...” (30:43–31:35)
• David Shook:
  “At best, we might have a few...repackaging companies that take ingredients or finished dose forms from China and India and repackage them to be sold as...U.S. product. They’re really not U.S. products, though.” (37:57–39:14)
• Amanda Head:
  “If anybody deserves the best quality and the best supply of this stuff, it’s our service members.” (24:35)

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Timestamps for Key Segments

• (00:55) – Amanda frames the pharmaceutical supply chain as a critical national security issue
• (02:11–13:37) – Interview with Sen. Tuberville: Fentanyl, terror threats, health care, domestic manufacturing
• (16:41) – Vic Suarez on vulnerabilities in the military drug supply
• (20:45) – Suarez explains regulation loopholes and procurement failures
• (25:00) – Suarez on American manufacturers losing market share
• (28:41) – Tom Neely testifies on generic drug market/sourcing crisis
• (33:26) – Neely: new onshore API facilities, calls for Commerce investigation
• (37:28) – David Shook: industry dominated by China/India APIs and the hollowing out of American manufacturing
• (43:22) – Shook: Danger of supply shock, insufficient reserves
• (46:05) – Suarez: expects multi-year turnaround, procurement reform needed

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Conclusion & Tone

The episode is urgent and combative, rallying for American self-sufficiency and diagnosing a bipartisan Washington consensus on the dangers of foreign pharmaceutical reliance—even as meaningful progress remains slow. Guests maintain a patriotic, no-nonsense tone, peppered with warnings, policy specifics, and calls for immediate executive action. The discussion unites manufacturers, policymakers, and veterans around the mantra that medicine is a national security asset—and America must act quickly to protect it.

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This summary is intended as a comprehensive guide for listeners seeking key takeaways, major arguments, and actionable insights from the January 1, 2026 episode of “Just the News No Noise.”

Transcript

[Amanda]

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[Amanda]

Hello America. Happy New Year to all of you. 2026. I can't think of a better way to kick things off than with a topic that we've, we've spoken about a few times in 2025. But it is something that is so pressing and the reason that we talk about it a lot is because it is a critical issue when it comes to national security. I, of course, am talking about the precursors and those initial ingredients that feed our pharmaceutical industry and not the vanity drugs. I'm talking about the generic drugs, the antibiotics that treat diseases just in case, you know, another pandemic shows up on our shores or the things that treat kidney disease or heart disease. These are crit issues in our country. And we've had a lot of these great guests on before, but we've got updates from them. So I am delighted to have these conversations starting out the new year. But before we get into the larger discussion about drug drug manufacturing, we got the chance to sit down with Alabama senator and gubernatorial candidate Tommy Tuberville. Now, he spoke about what his office is doing to reshore American pharmaceutical manufacturing as well as a number of other issues, including the president's drug boat policy, protecting the nation from Islamic terror. So take a look at this from Senator Tommy Tuberville.

[John]

I want to talk a little bit about an issue that gets so distorted in both the Democratic talking points and in the media, and that is the military's action to protect America from fentanyl, particularly these drug boats. You have some pretty clear vision on this. You know exactly what was happening. Americans want this right and there's nothing legally wrong with it.

[Senator Tommy Tuberville]

Well, we had a big hearing yesterday. We've had several in the, in the past month, and Pete Hegseth and President Trump are doing exactly what needs to be done. You know, since all of, all three of us have been alive, we've heard there's a war on drugs. There's not a war on drugs. To the president, United States said, this is going to stop. And he, he put his finger on it. He told the Secretary of War, I want this over with. And so they've done the right thing. They've been blowing these boats out of the water in the Caribbean and on the eastern side of the Pacific over around Mexico. And, you know, they're making a lot of progress. But it's not, John and Amanda, it's not just about drugs. This is about cutting off the supply line to the basically the capital of Central America for terrorism, and that's Venezuela. I mean, we have got to put our finger on these people. Maduro's got to go. And President Trump is bound and determined to squeeze him so hard that he will not be in leadership in a few months. And I think President Trump's got a great idea, great plan, and I'm looking forward to it working.

[Amanda]

Coach. There has been controversy surrounding this. I think for a lot of Americans, they don't even. They don't see the controversy in blowing up drug boats that, if they came to our shores, would kill Americans. But I do wonder if another aspect of this is that Democrats will use this if they win back the majority in the House next year, if they will use this as one of the first impeachment endeavors. Do you get that sense as well?

[Senator Tommy Tuberville]

Yeah, I think that they'll use it against President Trump and I think they'll use it against Marco Rubio, and I think they'll use against Secretary Hexag. That is their plan. They're not for anything that that is good for this country. Anybody that stands up and tries to protect drug, these narco terrorists bringing drugs into our country, which they've done for years now, we finally got somebody that's going to do something about it. And they're taking the side of the terrorists, and it just shows. They're showing their cards right and left. The mainstream media is on their side. If they were to win the House next year, it will be a full two years of impeachment processes. The American people will be the ones that suffered, won't get anything done. And that's the reason after this first of the year, the big beautiful bill is going to kick in, the tariffs are going to kick in. We're going to have a great year. Our economy is going to skyrocket. That's the entire plan. The Democrats have their fingers crossed. It doesn't work. But I am betting on Donald Trump.

[John]

Yeah, I think a Lot of Americans are. So I want to turn to the threat within our homeland. We can put a looking glass up to London and see what the left, the Islamists, the radical anarchists want to do to our country because they've already done much of it to Europe. We have so many threats on our soil. We just had a New Year's Eve attack preempted by some good work by the FBI. But do most Americans understand just how determined our internal enemies are right now?

[Senator Tommy Tuberville]

I don't think they do yet, John. They will. I'm going to be screaming from the rooftop. I've been telling my colleagues on the Republican side in the Senate, you've got to start saying something about this. Lindsey Graham did a great job Sunday on television. He and I talked about it today. We have got to. We got to inform people. It's absolutely amazing that if you just look at what's happened in Europe, as you said, London has fallen to the. To these Islamic terrorists. Well, you know who else has fallen is France. France had to cancel all of their Christmas celebrations this year because the Muslims put so much pressure on them. Now, listen, we have Muslims in this country that are good people. And I'm asking them today, if you are believe in our Constitution and you want to assimilate and make America greater by your work ethic and by paying taxes and doing things right, I need you to step up and speak with me to the radical Muslims saying nuff's enough if you don't believe in this country, but go home. Go back to where you came from. I think it's going to take a lot of people on their side even to step up and say something other than just politicians like myself and people here. But we are going to keep informing people across the country. This is a danger to the 250 years that we've had had on this great earth.

[Amanda]

Senator, there was a Muslim community center planned for production in the state of Alabama. It did get shut down at the first hurdle, as I understand that they can go back in, adjust their plans and reapply. But you were recently placed on a hate list, I believe, for care. And I know that you probably consider that a badge of honor, because it seems to me that in the state of Alabama, much like Florida and Texas, Sharia law and those types of beliefs and ideologies, they don't have a home.

[Senator Tommy Tuberville]

Yeah, well, man, as I said earlier, if you're a Muslim group and you're in this country and you teach things in the schools that are. You teach English, you teach Math, history, all the things good about our country, our constitution, I'm fine with that. I've got no problem. But the problem is I looked at their website. They teach Sharia law, they go by the Quran, who by the way teaches to kill the infidels. Which an infidel, by the way folks, is everybody that doesn't believe in Muhammad and Islam. And so at the end of the day, they didn't need to have a bigger stage which they wanted, a bigger area, a bigger school to continue to grow. And that's not going to happen again. If you're teaching hate in our country.

[John]

Yeah. So important to say it every day, not let that go unsaid every day. And I know you do, sir. I want to turn to the attack at Brown. A brave, young conservative woman, Ellen Knox, was killed there. We don't know either whether that was a target or just a victim. But the hatred, the, the case has raised a lot of concerns about what's been fomenting on campuses for a long time. Just want to get your thoughts first on Ella and also what we've learned thus far about the Brown case.

[Senator Tommy Tuberville]

Yeah, Ella Cook was a young 19 year old girl that in the summertime worked in an ice cream shop in Mountain Brook, Alabama. And she didn't have a worry in the world. She loved God, she was a Christian, she went to Brown to work on French history. She was an economic major along with mathematics, a very bright student. She was also vice president of the Republican Party at the school, the Young, Young group. And so we don't know, as you said, whether it was a target or not. But I'm going to tell you, these things like Charlie Kirk and the two young National Guard people here in Washington D.C. that lost their lives, there's a lot of things are adding up here. It's very seldom do you see anything happen to anybody on the left. It's usually somebody on the right, some Christians, some people, some person that's a patriot, that loves America. Ella Cook was that. I gave a speech about her today on the floor of the Senate. It brings tears to your eyes. I cannot believe, you know, we have kids. I've got two boys. I don't know what, you know, how I'd make it through life if I lost one of them through something like this. It's a, it's a grave tragedy and it's just, it's sad to see something like this continue to happen across this great country.

[Amanda]

Yeah, it seems like Mountain Brook has also gotten so much of a dose of their Young women enduring tragedy. I want to ask you before we let you go, because this ongoing health care debate percolating on the House side as well as the Senate side, a lot of people say that we're too far in with Obamacare. It can't be overturned, but we can patch it up. We can find fixes to it. What's your idea of fixing it?

[Senator Tommy Tuberville]

Well, it's a disaster. It's unaffordable health care. They've ruined our hospitals. They've run doctors out of the business. They run nurses to other jobs. Our rural hospitals are going under. It is a disaster. It needs to be fixed. And the problem is now the Democrats know that it's a disaster. So what do they need? They need $50 billion more a year to keep it going from the American taxpayers. And so we have to find a way to make this work. Now, I'm all for, for doing something in the short term to get us by till we can fix this absolute mess. But we've got to be willing to do it. We've got to be. As Republicans, we have the House, the Senate and White House. If we can't come up with a plan to fix Obamacare, it's not the Democrats fault. Who could care less about the American people or health care? They just believe in power. It is the Republicans fault. And we have to do something. And we, you know, it's. It's something that needs to been fixed five, six, ten years ago, but is completely in a tailspin now. And our health care is unaffordable and it's getting worse and worse. So we have to do something. Republicans, we can't count on the socialist communist Democratic Party to do anything to help make it better for the American people.

[John]

Time for Republicans to go on offense on this issue. They've been on defense too long. It's so easy to fix this. There's good ideas in the caucus to do so. Before we let you go, sir, another thing that we've learned about is how vulnerable our pharmaceutical supply chain is. I know this is something close to your heart. We're too reliant on India and too reliant on China, who's definitely not our friend.

[Amanda]

How.

[John]

How are we doing and starting to fix it? Looks like the Trump administration has taken this on, but a lot more work to be done.

[Senator Tommy Tuberville]

Yeah, we found out during the beginning of COVID which basically was the start of the Biden administration disaster. And of course they lied to us the whole time about COVID Fauci. He should be in jail today. I don't know what we're doing about that. He's a definite crook. Now I'm on the help committee, Health, Education, labor and Pension. I went through all those hearings and he spoke out of both sides of his mouth. Disaster. But we found out that we do not get any drugs from our country. They're all made overseas. President Trump has pushing the buttons to try to make it happen, to move back. We, for instance, in the state of Alabama in Huntsville, Eli Lilly just built a new plant or building a new plant in Huntsville with 600 to 1,000 employees making drugs. So they're moving back. We're giving tax incentives. We're pushing the narrative to get people to understand that we cannot live off Chinese and India pharmaceuticals. We have to be self sufficient. A lot of other things we need to do, but we can't live without that. And of course, the Biden four years, they did nothing about it. So we're four years behind. But President Trump's trying to catch up as he is in the economy and farming and health care, everything. President Trump's trying to dig himself out of water now. I hope that, you know, people will understand where he was and where we're at today. We're making lots of progress of bringing manufacturing back to this country.

[John]

Yeah, it's an exciting moment. People are going to wake up in 26 and feel an entirely different America just by the changes that were made this year. We're going to take a quick commercial break. More ahead right after these messages.

[Senator Tommy Tuberville]

The radical left knows exactly what they're doing. They want to steal the election.

[Tom Neely]

We're going to walk down Pennsylvania Avenue to peacefully and patriotically make your voices heard.

[Senator Tommy Tuberville]

Events in Washington have taken a violent and tumultuous.

[January 6th Patriot Narrator]

January 6th wasn't just a moment in history. For thousands of Americans, it was the moment their voices were taken.

[Vic Suarez]

It's insurrection.

[January 6th Patriot Narrator]

They were persecuted, hunted, seditious, conspiracy. But behind prison walls, something unexpected happened. They found their voice again, started singing the national anthem.

[Vic Suarez]

We took it up to him at Mar a Lago.

[David Shook]

I'll put my voice on it. Our supporters made this go real.

[January 6th Patriot Narrator]

America's voice is telling the real story of January 6th like you've never seen it before.

[Vic Suarez]

Everybody, this must be peaceful.

[January 6th Patriot Narrator]

This is not the story you were shown. I take responsibility. This is the story they lived Government.

[Vic Suarez]

Entrapment scheme that this actually was.

[January 6th Patriot Narrator]

The J6 Patriots are no longer staying silent. They are speaking. They are standing and they are telling the truth.

[Tom Neely]

You can't kill us. You can't beat us.

[January 6th Patriot Narrator]

They tried to silence them. Instead, they woke up an entire nation. The sleeping giant coming soon.

[Amanda]

Welcome back, everybody. Tonight we are talking all about America's pharmaceutical industry and the steps that we need to take so that we are not dependent on foreign countries for some of our crucial medications. And the Trump administration has made some positive progress on policy, but there are loopholes that our next guest says need to be addressed very quickly. So joining us now, he's a retired army colonel and now is the founder and principal growth partner at Blue Zone Bioscience and Supply Chain Solutions. Now back on April 30th of last year, he appeared before the Senate Armed Services Committee on Personnel. And his focus was holding the Pentagon accountable for making sure our service members get safe and high quality medications. Vic Suarez, welcome back to the show. Happy New Year to you.

[Vic Suarez]

Happy New Year, Amanda. It's great to be back on.

[Amanda]

Great to have you here. And as you and I were just lamenting over the break, you know, it kind of feels like we are screaming into the ether about this. It is a national security issue. And if anyone, if, if there is anyone who we should make sure have the drugs and the medications that they need at the quality that they need, it's our first responders and our first responders overseas, AKA our service members who protect us. But that has not always been the case, has it?

[Senator Tommy Tuberville]

Right.

[Vic Suarez]

This is a, you know, it's a multi year process. You know, we identified these risks several years ago. We obviously got some attention on this in the past year or so. And what we saw in the last maybe 45, 65 days is really the administration's been really focused on working with big pharma, big industry, the Health and Human Services, CMS, the FDA and HHS's ASPR team to really put in some strategic fixes in place, whether it's to lower drug prices or really motivate some of the big pharma companies to invest in reshoring their manufacturing. I think really that the next logical step right now is to take a bold action to fix the super majority of the medicines that everyday Americans take. And that's our essential generic pharmaceuticals, which is over 90% of the prescriptions dispensed every day to Americans.

[Amanda]

Yeah. And these aren't vanity drugs. These are things for chronic conditions, life threatening critical conditions, right?

[Vic Suarez]

Yeah, for sure. These are for people that have chronic diseases, such as if they have some type of kidney failure or they have some type of diabetes or heart disease. These are legacy drugs that have been on the market for well over 2025 years. And these are medicines that American manufacturers are making, but they're struggling, as your previous guests had pointed out, competing against either Chinese or Indian firms who found these loopholes to get their medicines to undercut American made drugs. And I think that's an area we really need to have, really, folks, policymakers, decision makers, administration officials, really tackle as we get into 2026.

[Senator Tommy Tuberville]

Yeah.

[Amanda]

And Vic, you know, we've had a couple, we're having a couple guests on the show tonight who have testified up on Capitol Hill, you being one of them. Who, who are the change makers up there? Do you feel like we have enough of the trailblazers in Congress to actually fix this? Because I hear a lot of rhetoric, I hear a lot of people talking about it on both the House and the Senate side. And yet frankly, for me, considering this is a national security issue, they're not moving fast enough.

[Vic Suarez]

Yeah, I mean, we can always want to see more people take some bold action. I think it's a matter of timing, right? This first phase was really to try to get some very large strategic fixes in place. Most favored nation pricing agreements. They're trying to fix health care. I think some emerging leaders that we're seeing pop up, at least on the Senate side is Rick Scott. Rick Scott has had now three hearings on this topic over the summer and into the fall. And I think that he's really emerging as one of the senior Senate leaders in this. He's really rallied up kind of a bipartisan effort, working across the aisle with Senator Gillibrand and others on Senate Aging Committee. And also I think there's some leaders like Senator Tuberville that are standing up and saying, hey, this is not tolerable anymore. This is not only affecting our national security, our war fighters, but small town America as far as, you know, citizens of his state and the access to the medicines that they need to have, preferably coming from American pharmaceutical companies.

[Amanda]

Yeah, Vick and I flicked at this at the top of this segment. These loopholes that are really, really dangerous and hindering what we can do to onshore, all of this manufacturing, one of which is so. So Chinese and Indian manufacturers can't sell directly to the US but they do something with respect to pharmaceutical packaging to get it here. Talk to us about that.

[Vic Suarez]

Yeah, I can clarify that a little bit. So with the Trade Agreement act backed in 1973, it's a federal law that basically prevents, let's say non Trade Agreement act nations, notably China and India, the two major ones in the pharmaceutical industry, from making A final dosage form medicine and then selling it to the federal supply schedule. Now they've always had the ability to sell it on the normal commercial marketplace if they wanted to sell it to a health system or through a distributor that was going to sell it to the civilian health care system. That's fair and open competition. The problem that we've seen is that they found a way to disproportionately gain market share selling it to the federal government, specifically to the Defense Department, to the VA and Health and Human Services through a loophole called the CS loophole, which was a court case that was settled in federal court In February of 2020, a month before the COVID lockdowns. And what that essentially did, that that court case did, was it allowed these companies, the complainants, to sell API or active pharmaceutical ingredients to suppliers and finished dose manufacturers in the United States and claim that the drug was substantially transformed in the United States, qualifying it as made in America. Prior to that ruling In February of 2020, what had been long since really ruled as an American manufactured drug is where the active pharmaceutical ingredient or API was actually produced. And there are several chemical synthesis steps to make an API. And that seems to be, or at least prior to the court ruling in February 2020, where the substantial transformation really is done is the active pharmaceutical ingredient. But due to that court case, the loophole has really been repackager companies, companies that are American companies, but they instead of buying their API or their finished dose medicine from a US manufacturer, they will source to somebody that can actually undercut and dump lower cost and oftentimes lower quality product coming in from normally TAA non compliant countries like India and China. And then they will get contracts specifically with the Defense Logistics Agency and sell directly to the military. And we've seen that over the last couple of years, as more information has come out, as more people have investigated this, that the military is dependent on these repackager companies.

[Amanda]

Oh, that's terrifying. How did that happen? How did it happen that they are dependent on those?

[Vic Suarez]

Well, part of it is, it's just really our federal procurement processes that favor lowest price, technically acceptable. And when we're dealing with things that are of low technical complexity, that contracting strategy is fine. If you, if you were going to have a lawn care service contract, you know, the complexity of that and the effect on a human or on a, on a system is very negligible. But when you start talking about a pharmaceutical that goes into the health of an individual, now we're talking about a contracting strategy, strategy that should be closer to what we call best value, which basically factors in not only the quality of the product, the resiliency of that supply chain, but also looks at things like the location of where the manufacturing is, is being done so that you can look at a total best value of the product. Is it in the long run, in the best interest for the fit, for purpose of what it's intended to do. And when we, we talk about pharmaceuticals, we should go to a best value standard which takes in quality, location of manufacturing and the resiliency of that supply chain.

[Amanda]

Yeah. I mean, if anybody deserves the best quality and the best supply of this stuff, it's, it's our service members. I know that the Trump administration, President Trump, this, this is something that is very much on his radar. He is taking steps to ameliorate the issue. However, I've still seen some news blurbs here and there that there are some American manufacturing, pharmaceutical manufacturing companies that have gone out of business. Why is that?

[Vic Suarez]

Yeah, so some of these American companies are really struggling. I know of one particular company that makes antibiotics in the United States. It's all, it's like one of the few, if not the only, antibiotic manufacturer in the country. They testified in the Senate this past summer that even though they're one of the few manufacturers that can make a very common drug, amoxicillin, they can make it end to end 100% United States. They only make up about 5% of the sales to, let's say the Defense Logistics Agency and sell to the military and other foreign players can actually get a higher market share through either these loopholes through repackager relabeler companies or an ability to negotiate better contractual terms with selling it to the Federal Supply schedule. And so one of the things we can do to remedy this is to really look at these American manufacturers and say why aren't they getting the proper market share and why aren't we bolstering their demand, selling it to the Federal Supply schedule as kind of an initial guaranteed way to have them supply our service members, their families, veterans like myself, those high quality medicines here. And, and then secondly, as they build up those sales from 5% to let's say, 20 or 30 or 40% of the market share, they could then more easily sell into the civilian marketplace as well because they will be able to lower their cost of goods over the long run once they can scale their manufacturing demands.

[Amanda]

Yeah, Vic, you have such an incredible periscope into all of these issues. We appreciate you being here with us and shouting this from the rooftops because it is an issue that needs to get solved. Like yesterday. Vixoir, as founder and principal growth partner at Blue Zone Bioscience and Supply chain Solutions, thanks for being with us tonight and happy New Year.

[Vic Suarez]

Thank you. You too, Amanda.

[Amanda]

Oh, actually, Vic, you're gonna stick around because he's gonna be back with us, I think, at the end of the show to wrap this up and put a pretty little bow on it for all of you. All right, everybody, we're gonna take a break. We'll be back.

[Vic Suarez]

This holiday season.

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[Amanda]

Be one of the first 50 people to sign up and win a hat automatically. Hurry while there's still time.

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[Amanda]

Welcome back, everybody. We want to continue our conversation now on the crisis of pharmaceuticals that are being manufactured overseas because it still presents a major vulnerability here in our country. The government has taken initial steps to help American drug manufacturers onshore. All of that. And the Senate actually also hosted a hearing back in November titled Made in America Restoring Trust in our Medicines. And our next guest, Tom Neely, testified in that special hearing. Here is just a part of what he said.

[Tom Neely]

Unfortunately, in today's domestic market, offshore manufacturing of these generic medications has dangerously weakened our supply chain. With China and India controlling the market, these foreign competitors are heavily subsidized by their governments, and studies repeatedly have shown quality of their finished products is inferior to domestic produced generics. In addition, the three big distributors, PBMs and insurance companies, care nothing about quality but focus on price.

[Amanda]

Joining us now is the man that you just saw in that video, the chairman of the board at Oxford Pharmaceuticals, Tom Neely. Tom, thanks so much for being back with us.

[Tom Neely]

Thank you, Amanda. I appreciate it.

[Amanda]

Absolutely. I know you've been sounding the alarm on this for a very long time. Take us back to that Senate special hearing because, you know, when, when a witness goes in to testify before these committees, you can typically tell how receptive the ears and the minds are of the people who are in that hearing. Did it seem like your concern over this translated and resonated with them too?

[Tom Neely]

Absolutely, 100%. On both sides of the aisle, too. Both the chairman and ranking member, I think, are directly in path with each other on this situation that we face.

[Amanda]

Yeah. Tom, the nature of generic medications, these, these are items that are used daily. They obviously, because they are outside of what's often a seven year patent period, there are multiple versions of it, but we are, when it comes to generic medications, these are often highly used medications in this country. And yet so much of the, of the initial pharmaceutical ingredients, they, they're manufactured in countries that are. Either it's China, which is adversarial, or it's India, where quality control, frankly, is close to being in the gutter.

[Tom Neely]

It is terrible. So you're exactly right. 90% of the prescriptions that doctors prescribe, patients domestically are generic drugs. So it's the drugs that I make every day, people that my neighbors, my family, we take on a daily basis, their maintenance medications like high blood pressure and various other ailments. These drugs, this is not big pharma. These drugs per dose, we sell a dose for a penny and a half. So we sell 100 doses for A$50. And we have to depend on a lot of the raw materials coming from China. They have 90% of the active pharmaceutical ingredient market in the world now. Also, who manufactures these generic drugs is India. Again, they're heavily subsidized and they really don't care anything about quality. And quality is expensive, as I tried to mention. But it's a moral obligation that we have as a domestic manufacturer. And when I'm selling 100 doses for $1.50 and yet when it goes through the system and Medicare reimburses that $1.50, they reimburse to the insurance company, on average $13.25. There should be a lot of reform on both sides of this equation. On the manufacturing side, we need to. Onshore, we need more Oxfords in this country. On the reimbursement side, we need to really reform PBMs, the distributors, as well as insurance companies.

[Amanda]

Absolutely. All right, Tom, this is getting into kind of the nitty gritty and the nuances of what happens in the manufacturing process. But I feel like, like you're probably the perfect person to dig into this. Obviously, China, a producer of these precursors that then come to you for you to compile this drug, China's ingredients, whether they are, whether they come from the earth, whether they are created in a lab. Is it just not possible for us to get those things here? Why don't we have those things here so that companies like yours can produce.

[Tom Neely]

The precursors too now and in the past, it's been a problem. We used to, but the permitting to build an API facility in the last several years was overbearing. That's beginning to change. And I don't know if you're familiar with it, but the state of Alabama just was awarded a huge API facility that Eli Lilly is building an hour away from US. There's a 6 billion dollar investment they're making for the US and for the state of Alabama. That's huge. We don't compete with Eli Lilly. They're branded drugs, as you, you're familiar with. We're in generics, but we've got to begin to bring API facilities onshore. In addition, you're exactly right. When it comes to India, 55% of all generic drugs are made in India. And the quality that they're providing in the United States, there's no checks and balances there. If I purchase an API or raw material from China, my quality starts from the day it hits the dot, meaning I have chemists, I have documentation that I review. So I know that that raw material is, is meets the standards that the FDA has put out for us. Now, on the flip side, in India, when they send a completed tablet to the US there's no checking after they send it and they ship it to the distributorship.

[Amanda]

Incredible. Tom, what I love about your message is that most companies out there, most CEOs out there, would not be asking for competition. But you are saying there need to be more Oxford Pharmaceuticals. So for you, it seems like this is a patriot mission because you recognize the national security aspect of it.

[Tom Neely]

That's right. And I fully support an ongoing Commerce department investigation of 232 that would allow the government to act faster. The government, you know, it takes a long time to pass a bill, but since everybody's in agreement, if the Commerce department affirms that 232, it gives a whole lot of it clears up a lot of the red tape, let me put it that way. And the administration can pursue some of these initiatives through va, through Medicare, through the Dow, that absolutely has to occur. And when you bring on the volume and that you say buy USA made product, that will attract competition on shore, which I welcome.

[Amanda]

Absolutely. Tom, we love what you're doing. Thank you so much for spreading the word on Capitol Hill and also here on our show. Hope you have a very happy new year. Tom Neely, chairman of the board at Oxford Pharmaceuticals, thank you so much, sir.

[Tom Neely]

Thank you, Amanda. I appreciate it.

[Amanda]

All right, everybody, coming up on the other side of this break, we have much more in this very, very critical issue. We'll be right back. Foreign. Welcome back to Just the news. No noise. We have another American pharmaceutical manufacturer to get to now to explain what more needs to be done to revitalize the industry here in the United States and shore up our national security when it comes to this issue. So joining us now, David Shook. He is the co founder of Argentum. David, welcome back. Happy New Year.

[David Shook]

Happy New Year to you as well, Amanda. And thank you for having me on the show.

[Amanda]

Absolutely. Thanks so much for being here. And from, from the manufacturer side of things, if you, if you had to send out a memo to every single person on Capitol Hill, every advisor over at eeob, everybody in the White House talking to President Trump about this, what would be the top two or three things that you would say, boom, boom, boom, this needs to be done to fix it all. And maybe there's more than three, but what are the top three?

[David Shook]

Sure. So first of all, I would want to thank President Trump for all of the work that I've seen from the administration so far on just being aware of this issue and being interested in addressing it. What we've seen so far are a number of major announcements between the administration and the branded drug industry, also known as big Pharma. But really big Pharma has nothing to do with this issue that we're talking about today. What we have today is basically almost no US truly US generic drug industry, meaning that the APIs come from China. The key ingredients that go into making generic drugs come from China and India. The finished dose forms come from China and India. At best, we might have a few what your previous guest Vic referred to as repackaging companies that take ingredients or finished dose forms from China and India and repackage them to be sold as, quote, unquote, US Products. They're really not US Products, though. So this is the problem that companies like ours and a few others are looking to address and looking to sort of raise awareness on this issue.

[Amanda]

How on earth did that become the thing? Because this also Happens by the way, in the food industry, everybody knows I think at this point now that if you buy beef that was manufactured elsewhere, as long as it's packaged here in the United States, they slap that label on there and they are legally able to say product of the usa. Is that kind of what we're talking about here with pharmaceuticals?

[David Shook]

I, I actually can't speak to food. I don't, I am not an expert on food. That's really interesting and I'd love to learn more about that. But I'm guessing you may be right that this is, but what this really comes down to is price. And you know, I look, pricing and cost in the healthcare industry is a hot button issue for everybody, you know, and pharmaceuticals is no different in. But really that issue with price has a lot to do with, has everything to do with branded drugs, generic drugs, sort of. There's an entirely different set of economic rules that dictate generic drugs. It is all about how can we get this at the cheapest cost possible. And it is then sold through an intermediary marketplace, ultimately to pharmacies. And these are drugs that really nothing has mattered in the industry more than how can you sell me the absolute lowest cost version of this drug? And what I'm talking about when I say this drug, I mean the vast majority, meaning 90% plus of critical essential medicines in this country are generic. Big pharma has nothing to do with making or selling those medicines. And so because it's so dictated by how can the industry, the buying industry in this country just simply get the cheapest version of that drug so long as it's approved by the fda? That has been the reason why the US manufacturing of generic drugs has become so hollowed out.

[Amanda]

Yeah, talk to us about Argentum because you, you like another guest we had on the show, it seems like you are one of those folks who you care about having this here in the United States so we can check on quality control. It can be right here under our thumb. Because all of your operations are here, right?

[David Shook]

Correct, Correct.

[Amanda]

Was that hard to do? Is that hard to have all of that here?

[David Shook]

Well, we are a effectively a startup company. We're a new business. We're private, privately held, US based, American owned generic pharmaceutical company. And we have been for a number of years now investing in bringing new generic drugs to the market. And what we're now investing in a little bit of a nuance here is investing in bringing old generics to the market, meaning existing generics, meaning that we want to create generics that are already available in the US Coming from China and India. But manufacture some of those critical medicines right here in the US to the extent possible, using active pharmaceutical ingredients and key source materials also manufactured in the US or derived from US Sources. That's, that's the role that Argentum is looking to play in this, in, in correcting this issue.

[Amanda]

I love that. So, David, help me look at a hypothetical scenario just so our audience can get an idea of the direness of this situation. Now, obviously, supply would not be cut off from India and China for the same reasons. For China, it would probably something. Be something having to do with the trade dispute or, or something involving our technology sector. And it would be a deliberate cut when it comes to India. Maybe it's a quality control thing. Maybe they have to recall medications and we have to stop importing drugs from them. If that happened from either country or both, how long would our current supply that we have here in the United States last? For some, for some pretty critical conditions like liver disease, heart disease, I mean, these are chronic issues that can be life threatening if medication is deprived for days.

[David Shook]

Many of these drugs are. There is effectively 16 week supply on. And this varies by drug. It could be less than that, it could be more than that. But there is, you know, you're talking about just a period of a few months of supply that we have on hand in this country for most of these drugs. And these are, I'm talking about everyday antibiotics for kids, everyday antibiotics for hospitals, tabs and caps for dozens of different chronic diseases such as rheumatoid arthritis or osteoporosis or certain cardiac conditions. All of these drugs we just don't really think about. We take them for granted.

[Senator Tommy Tuberville]

Right.

[David Shook]

And, and they have always been there. Sometimes there's an issue with supply that gets corrected after some period of time. Sometimes there's a safety issue that gets corrected over some period of time. But I think that the underlying issue is just if, if 100% of this is coming from, from outside the U.S. is that a strategic concern? Should that be a strategic, strategic concern? We think it, it should be and we think there should be more attention paid to this.

[Amanda]

Yeah, I mean, look at it like a financial advisor would. Diversify your portfolio. You never want everything coming from one source. David Shook, co founder of Argentum Pharmaceuticals, thanks so much for your perspective on this tonight.

[David Shook]

Thank you for having me on, Amanda.

[Amanda]

Absolutely. All right, everybody, we've got more on this coming up after the break. Welcome back, everybody. Let's pull this all together and put a Pretty little bow on it. And the perfect person from this show tonight to bring back on to help me do that is Vic Suarez. He is the founder and principal growth partner at Blue Zone Biosciences and Supply Chain Solutions. Vic, thank you so much for coming back. I promised my audience that you would come back on with me to help me dissect all of this one more time before we head out. So I think the first thing I want to ask you is timeline. All right. So, so if history, and when I say history, I mean this past year since President Trump has been back in office, so very recent history, if history has shown us what the future is going to look like as as far as implementing a lot of the solutions that you spoke about on Capitol Hill, a lot of the solutions that you've spoken to us about on the show, do you anticipate that this time next year if we do another special like this with you, that we'll be saying this is 100% fixed, this is 50% of the way, what do you expect for that timeline?

[Vic Suarez]

Yeah, so I don't think we can say it's going to be 100% fixed by next year. This is a multi year effort, somewhere in the range of three to five years to kind of put in irreversible momentum in about a decade to completely reverse our over reliance on overseas supply chains for essential generics. I do think though that if we revisit this topic again by next summer 2026, one of the great things to maybe put as a milestone marker of success is do we have all the programs in place to start to ignite more companies like your guests that you had on there to get into the game of making quality medicines here in the United States or existing companies like Oxford that you had on earlier where they are able to get market share or grow growth in market share because they're manufacturing drugs in the United States and selling them to either civilian hospitals, distributors or even the military health system. And I think that's kind of going to be really the telltale marker is next summer. Are we really seeing an uptick in this area? Back to you.

[Amanda]

What is the reason, Vic, that we don't have more Oxford Pharmaceuticals or Argentums? Is it a profit, profit thing? Because obviously you're not going to make as much money, I would think, on, on pharmaceuticals just because the price of it is so much lower than it is. Some of these retail, you know, these, these brand name drugs. What is, what is the obstacle that's stopping there from being more of those Types of companies here in the U.S. yeah.

[Vic Suarez]

The biggest thing is, is really the, the, the competitors that, that they're competing against are not playing by the same rules. Right. So these companies typically will ensure that the quality of these medicines are adhered to. They're not going to cut corners when it comes to those things also because the regulatory agency is really right in their backyard. And so part of this has been now decades in the works of really an uneven playing field where the regulatory agency was, you know, holding to the standards with these American companies and therefore they had their cost of goods sold were at a higher margin and as a result they weren't as profitable. And so when they're competing against companies that are playing by these loopholes or where the regulatory agency isn't able to monitor them as closely, then there's a distinct advantage of moving those supply chains and those manufacturing overseas. And that's really been due to just out of the 80s and 90s, this globalization movement in all the sectors. And so one of the things that is really keeping a lot of these companies from able to really compete on an even playing field is something as simple as how we do procurement policy. So this is really a message to those that are in the procurement business, whether they're in the federal government at the va, the military health system or HHS is we really need to follow some of the guidance we've seen from the executive orders about preferring true procurement practices towards true American made products and really decipher that away from those that have used these loopholes and say that they're American made products. That's something you can do without legislation. You might deal with it in court like you did in, like the federal government did in February of 2020. But I think we, we are now more informed about the ramifications of not doing this. And so I would just encourage policymakers, those that lead these agency procurement offices to really re look their procurement methods in favor of American made medicines.

[Amanda]

Yeah, absolutely. I hope this time next year we are saying that it's at least 50% better. I would be happy with that, Vic. I think you probably would be too. But like you said, this is multi years. This is, this is going to take a bit but once we get there it's going to be incredible and I think it will happen by the end of this term under President Trump. Vic Suarez, thanks so much for being with us. Thank you for everything you do over at Blue Zone bioscience and we'll talk to you in the New year.

[Vic Suarez]

Happy New Year.

[Tom Neely]

To you.

[Vic Suarez]

Thank you.

[Amanda]

Thanks so much. All right, everybody, that's going to do it for us tonight. We appreciate you being with us, and thanks for being keen on, on hearing about these issues. It's very important. You know, there have been a lot of hearings like Vic participated in up on Capitol Hill. But I think enough hearings have happened. They've heard everything they need to hear and they just need to act on it. So we'll be all looking forward to those types of actions in the new year. Everybody, have a great evening. And we will be back tomorrow. Regular time, 6pm Eastern. See you then. This is an iHeart podcast, Guaranteed Human.