How Big Pharma Weaponized the FDA to Kill Your Access to Personalized Medicine

0:00 Big Pharma is using the FDA to shut down

0:02 compoundingarmacies and prevent you from getting the medication you need.

0:06 Buckle up, y'all, because you're going to want to hear this one.

0:08 This is the story of how big pharma is systematically dismantling access to TRT,

0:12 essential fertility meds, and personalized care across America.

0:16 How they've weaponized the FDA,

0:17 bought state legislatores, deployed armies of lawyers,

0:20 and manipulated drug shortage lists,

0:22 all to protect their record high profit margins.

0:25 And before this video is over,

0:26 I'm going to tell you why I believe this is happening now.

0:29 and involves a dinner at Mara Lago, Trump RX,

0:32 and an alleged deal that I believe traded

0:34 your access to affordable medication for a political win.

0:37 But I'm not here to complain.

0:38 I'm a surgeon and I fix things.

0:40 So, I'm also going to lay out a solution and what

0:42 the people in power need to do to fix this for patients.

0:45 Now, if you are a legislator, a regulator,

0:47 or an adviser to anyone who can influence this fight,

0:50 and you only have 5 minutes, click the timestamp in the description down below

0:53 that says a message to people who can stop this.

0:55 I have a personal message for Secretary Kennedy,

0:58 Commissioner Mackery, Deputy Secretary O'Neal, Dr.

1:00 Brener, and Admiral Christine.

1:02 And I mean every word of it.

1:04 My name is Dr.

1:05 Alex Tatum.

1:05 I'm a board-certified urologist fellowship trained

1:08 in men's health in practice in Indianapolis, Indiana.

1:10 I prescribe compounded medications every single day.

1:13 I've seen what they can do for patients and I've

1:15 seen what happens when that access gets taken away.

1:18 Let's dig in.

1:19 Now, before we get into this war, you have to understand the battle lines.

1:22 Starting off with this.

1:24 What are compoundingies?

1:26 What you're probably familiar with are commercialies like CVS or Walgreens.

1:29 Thesearmacies are responsible for distributing prepackaged

1:32 medicine that they receive from drug manufacturers.

1:35 They don't actually make any of the medication themselves.

1:38 Compoundingarmacies, on the other hand,

1:39 actually make the medications they provide to patients,

1:42 which allows for custom formulations when the cookie

1:44 cutter options from CVS just won't cut it.

1:47 And this isn't some fringe practice.

1:48 It's one of the oldest traditions in medicine.

1:50 Before big pharma, all pharmacy was compounding.

1:53 Your local pharmacist mix your medications by hand,

1:56 tailored to your specific needs.

1:57 And in the modern era, most compounders have evolved into complex industrial

2:01 outfits that still allow for custom medications,

2:03 but at quality levels that meet or exceed what's available commercially.

2:07 Today, compoundingies exist under two federal frameworks.

2:11 503A operate under individual prescriptions.

2:14 A doctor writes a script, the pharmacist compounds it for that specific patient.

2:18 503b outsourcing facilities can produce larger batches

2:21 for hospitals and healthcare organizations without individual prescriptions,

2:24 but they operate under stricter FDA oversight.

2:27 Both are legal.

2:28 Both are highly regulated, and both exist because Congress recognized

2:31 that oneizefits-all drugs don't work for every patient.

2:35 Think about it this way.

2:36 You've got a patient who's allergic to a dye in a commercial medication,

2:39 or a child who can't swallow a pill and needs a liquid formulation,

2:42 or a man on testosterone replacement who needs his meds mixed in grape

2:45 seed oil instead of the commercially available

2:47 cotton seed oil due to injection sensitivity.

2:50 That's compounding.

2:51 It's personalized medicine, the thing that every big pharma marketer

2:54 loves to put in their mission statement, but doesn't actually want you to have.

2:58 Oh, and did I mention that compounded meds usually

3:00 cost a fraction of what their commercial counterparts do?

3:03 And that's where things start to go very very wrong.

3:06 As compounding has become more and more sophisticated and more and more

3:09 providers start to realize that personalized medicine is the way of the future,

3:13 big pharma started to view compounders as a threat to their bottom line.

3:16 One that had to be eliminated at all cost

3:18 regardless of how many patients got hurt along the way.

3:21 The first major blow came on March 23rd, 2020.

3:24 Under pressure from the Pharma lobby,

3:26 the FDA introduced their Biologics Price Competition and Innovation Act.

3:30 This reclassified dozens of medications that have

3:32 been available for decades from drugs into biologics.

3:36 Overnight, compoundingies lost the ability to produce

3:39 them unless they obtained a biologics licensed application,

3:42 a BLA, which costs them millions of dollars and takes years to obtain.

3:46 Among the casualties, human corionic gonadotropen, hCG.

3:50 This is a medication that I prescribe every

3:52 single day to fertility patients and men on TRT.

3:54 Before the ban, a vial of compounded hCG cost 50

3:58 bucks and I could provide precise dosing that matched the patient.

4:01 Afterwards, the only FDA alternatives, Pregnil and Noval,

4:04 often cost over $1,000 for the same meds.

4:07 Oh, and insulin was on that list, too.

4:09 And so were other critical medications that millions of Americans depend on.

4:14 And here's the kicker.

4:15 To date, the FDA has approved

4:16 exactly zero biologics license applications from compoundingies.

4:21 Not one.

4:21 They created a pathway that is functionally impossible to navigate.

4:25 And then they use the absence of approvals

4:27 as evidence that compounders can't meet standards.

4:29 It's circular logic with no way out dressed up as regulation by design.

4:34 While the biologics reclassification was the opening salvo, the FDA wasn't done.

4:38 They turned their attention to the largest 503b outsourcing facilities,

4:42 particularly Strive and Empower Pharmacy,

4:44 the largest compounders in the United States.

4:46 They were put under relentless regulatory pressure.

4:49 We're talking FDA inspections, warning letters, and legal challenges,

4:52 all while continuing to serve millions

4:54 of patients who depend on affordable compounded medications.

4:57 And every time the FDA finds a documentation issue or procedural technicality,

5:01 it gets amplified into a narrative about patient safety risk,

5:04 despite the total absence of any significant

5:07 adverse event data tied to those products.

5:09 Let me be clear, I'm not saying compounding shouldn't be regulated.

5:13 They absolutely should, and they are.

5:15 Quality matters, sterility matters, and dosing matters.

5:18 But there is a difference between legitimate oversight and a coordinated

5:22 campaign to regulate an entire industry out of existence.

5:25 And guess which one we're seeing right now.

5:27 And then came the GLP-1s.

5:29 And the Cold War went thermonuclear.

5:31 For those of you that are new to this, GLP-1 receptor agonist.

5:34 Drugs like Osimpic, WGO, Mjaro,

5:36 and Zeppbound are the biggest pharmaceutical blockbusters since Viagra.

5:40 We're talking about medications that help

5:41 people lose significant amounts of weight,

5:43 improve diabetes, and reduce cardiovascular risk.

5:46 These are genuinely transformative drugs.

5:48 And I'm not here to bash the science.

5:50 The science is incredible.

5:52 But here's the problem.

5:53 These drugs cost $1,000 to 1350 or more per month without insurance.

5:58 And many insurance plans don't cover them for weight loss.

6:00 And the demand was so overwhelming that it created a nationwide drug shortage.

6:05 Shortages that the FDA officially acknowledged.

6:07 In 2024, Eli Lilly's GLP1 drugs, Mangaro and Zepbound,

6:11 generated over $36 billion in revenue with a B.

6:16 Novo Nortis Oimpic alone pulled in 16.7 billion.

6:19 Combined, these companies are on track to generate $69 billion

6:23 in GLP-1 revenue in 2025 with projections reaching 91 billion by 2035.

6:28 The GOP1 market is projected to exceed a hundred billion by 2030.

6:32 We're talking about a market so massive that it makes

6:34 the GDP of some countries look like a lemonade stand.

6:38 And under federal law, section 503 of the Food, Drug, and Cosmetic Act,

6:42 when a drug is in shortage, compounding are legally permitted to compound it.

6:46 And this is a purposeful safety net that Congress

6:48 built into the system for exactly this type of situation.

6:52 So compounders stepped up.

6:54 They began producing compounded simaglutide and trespathide

6:57 at a fraction of the cost,

6:59 $100 to $300 per month compared to over $1,000 for the commercial product.

7:04 Patients who had been priced out of treatment finally had access.

7:07 Clinics like mine could actually help people.

7:09 And big pharma lost its mind.

7:12 What happened next was one of the most

7:13 aggressive corporate lawfare campaigns in modern pharmaceutical history.

7:17 In April 2025, Eli Liy filed federal

7:20 lawsuits against Empower Pharmacy and Strive Pharmacy,

7:23 calling their compounded trespatide products knockoffs.

7:26 They sent cease and desist

7:27 letters to approximately 50 additional compoundingies.

7:30 By July, they were back in court,

7:32 filing again in the Southern District of Texas.

7:35 Not to be outdone, Nova Nordis followed suit in August of 2025,

7:39 filing against 12 defendants.

7:41 These lawsuits didn't allege patient harm.

7:43 They didn't point to contaminated products or adverse events.

7:46 They alleged trademark infringement and patent violations after

7:49 these veryarmacies bailed them out of a drug shortage.

7:52 This was corporate litigation strategy, not patient safety advocacy.

7:56 And then it escalated again on February 9th, 2026.

8:00 Literally the day that I'm recording this, Nova Nortis

8:02 filed a patent infringement lawsuit against him and hers.

8:05 Not a trademark claim, not a false advertising suit, a patent suit,

8:09 US patent 8129343, the most aggressive legal weapon in their arsenal.

8:14 They're seeking a permanent ban

8:15 on him selling any compounded simaglutide product

8:18 and damages that their general counsel says

8:20 could be in the hundreds of millions.

8:22 Him stock tanked over 19% in pre-market trading.

8:25 But here's where Novo Nordis general counsel

8:27 John Kuckleman said the quiet part out loud.

8:30 In an interview with CNBC, Kuckleman stated, and I quote,

8:33 "We do want an end to mass compounding." Let me say that again.

8:37 The general counsel of a pharmaceutical company that generated $16.7 billion

8:42 from a single drug openly stated that they want to end compounding.

8:46 He then claimed that compounded medications

8:48 are untested and putting patients at risk.

8:50 But here's what he didn't provide evidence.

8:53 No adverse event data, no contamination reports,

8:56 no clinical outcomes showing patient harm from compounded simaglutide.

8:59 Just the assertion from a lawyer, not a doctor,

9:02 who never took the hypocratic oath that patients are at risk.

9:05 That's not a safety argument.

9:07 That's a legal talking point dressed up as concern.

9:10 Cuckleman went even further,

9:11 warning that teleahalth companies and compounders should be very,

9:14 very much on notice and that Novo has filed around 130 lawsuits so far.

9:19 He praised companies like Row for doing the right

9:22 things by transition to sell Novo's FDA approved products.

9:25 Translation: The good companies are the one funneling revenue back to us.

9:28 Everyone else gets sued.

9:30 Now, let's talk about the timeline that brought us here.

9:32 Last Thursday, his and hers launched a compounded

9:35 oral simiglutide tablet for 49 bucks a month.

9:37 By Friday, the FDA announced enforcement action.

9:40 Commissioner Mackery threatened seizures and injunctions,

9:43 and the HHS general counsel referred HIMS to the Department of Justice.

9:47 By Saturday, HIMS had pulled the product and today,

9:50 Monday, Nova filed the patent lawsuit.

9:53 Four days from product launch to DOJ referral to patent suit.

9:57 Meanwhile, it takes the FDA six years to not

9:59 approve a single BLA from a compounding pharmacy.

10:02 Now, I want to be fair here, and I mean that.

10:05 I'm going to steal man the other side for a second.

10:08 On the surface, HIMS launching a compounded oral semiglutai

10:11 pill just one month after the FDA approved oral WGOi.

10:14 Yeah, I can see how that looks aggressive

10:16 and I can see why regulators raised an eyebrow.

10:18 That's fair.

10:23 But here's what nobody is saying.

10:25 Oral simaglutide is not new.

10:27 Novon Nordisk, the same company suing HIMS right now,

10:30 has sold Ribbelis, an oral simaglutide tablet, since September 2019.

10:35 That's over 6 years.

10:36 Ribbelis is approved for type 2 diabetes.

10:38 And yes, WGO is approved for weight loss,

10:40 but they're the same molecule, semiglutide.

10:43 The only differences are the indication on the label and the available doses.

10:46 Oral GOP1 receptor agonist have been a thing for over half a decade.

10:50 So, let's stop pretending that compounded oral

10:52 semiglutide is some sort of reckless experiment.

10:55 The science of oral simaglutide delivery has been established since 2019.

10:58 And here's where the dosing problem gets real.

11:01 Let's say a patient is approved for oral WGOi.

11:03 The available tablet strengths are 1.5 millig,

11:06 4 millig, 9 millig, and 25 millig.

11:09 But what if a patient does best at 7 milligs?

11:11 That dose exists, but it's a ribbelis dose.

11:14 But because ribbelis is a different brand with a different FDA indication,

11:17 you can't just switch between them

11:18 the way you could with a compounded formulation.

11:21 Your insurance won't cover a diabetes drug for a weight loss indication.

11:24 And if you're paying cash,

11:25 you're now juggling two different brandame medications from the same company

11:29 instead of getting a single compounded

11:31 prescription tailored to your custom dose.

11:33 That's not personalized medicine.

11:35 It's the problem that compounding was designed to solve.

11:38 Let me get a little nerdy for a second because this matters.

11:41 Both ribbs and oral wobbi rely on something called snack.

11:45 That stands for sodium N82 hydroxybenzoil aminoap,

11:49 also known as saloproate sodium.

11:51 I know it's a mouthful and I probably didn't say it right,

11:54 but here's what it does.

11:55 Simaglutide is a peptide and peptides get destroyed in your stomach.

11:58 Acid breaks them down.

11:59 Your gut wall won't absorb them.

12:01 Snack is an absorption enhancer, a co-formulated exipient that creates a local

12:06 pH buffer around the simaglutide molecule, protects it from gastric enzymes,

12:10 and facilitates its transport across

12:12 the gastric epithelium into your bloodstream.

12:14 Without snack, oral simaglutide doesn't work.

12:16 The bioavailability is less than 1% even with snack.

12:20 But that's enough because simaglutide is incredibly potent.

12:23 So here's the question that Nova Nortis lawyers don't want you to ask.

12:26 What if a patient has a hyper sensitivity or an allergy to snack?

12:29 What if they can't tolerate the exipient that makes oral simaglutide work?

12:33 Well, for that patient, a compounded formulation of simaglutide,

12:36 one that uses a different delivery mechanism

12:38 or a different absorption enhancer could be the answer.

12:41 That is textbook compounding.

12:43 That is literally why compounding exists to serve

12:45 patients who can't use the commercial product as is.

12:48 But if Novo Nortis lawyers have their way, that patient is out of luck.

12:51 They get nothing because John Cuckleman wants to end mass compounding.

12:55 And here's the beautiful irony.

12:57 In that very same CNBC article,

12:59 Cuckleman acknowledged that compounding has to be based on legitimate grounds,

13:02 including when a patient is allergic to a specific ingredient in a branded drug.

13:07 His own words.

13:08 So, when NOVA admits that allergies to drug ingredients are a legitimate basis

13:11 for compounding while simultaneously suing to eliminate

13:14 the companies that would provide those alternatives,

13:16 you can't have it both ways.

13:18 Either compounding serves a medical purpose or it doesn't.

13:21 Pick one.

13:21 Think about that timeline again.

13:23 The FDA has taken six years, six years,

13:26 and still hasn't granted a single BLA to a compounding pharmacy.

13:29 But a company launches a $49 product that threatens a 100

13:33 billion revenue stream and there's a DOJ referral in 24 hours.

13:36 Patent lawsuit in 4 days.

13:38 Makes you wonder whose safety they're really protecting.

13:40 Now, if you think this fight is

13:42 just happening in federal courtrooms, you're wrong.

13:44 It's happening in your state legislature.

13:46 Maybe right now.

13:47 It isn't mine.

13:48 Right here in Indiana.

13:49 as Senate Bill 282 was introduced in January 2026 and its original version would

13:54 have effectively banned all compounded medications.

13:56 A bill in my state legislature would have prohibited

13:59 the compounding medication that I prescribed to almost all

14:02 my patients and it passed the Indiana Senate

14:04 on January 29th and is now headed to the House.

14:07 Now, yes, it's been amended from its original version.

14:09 The scope has been narrowed supposedly to focus

14:11 on GOP1 medications and adding oversight requirements,

14:14 but make no mistake, this is a test case,

14:17 and this is how the dominoes start falling.

14:18 You restrict compounding for one class of drugs.

14:21 You set the precedent and then you come back for everything else.

14:24 And who introduced this bill?

14:25 State legislators from Indiana, aka the home of Eli Liy's global headquarters.

14:30 The same Eli Liy that spent 6.7 million on federal lobbying in 2024 alone.

14:35 The same Lily whose pack contributed

14:37 1.86 million to political candidates that cycle.

14:41 And the same Lily that provided $233,000 in corporate

14:44 political contributions to Indiana state candidates and committees in 2024.

14:48 You don't have to be a conspiracy theorist to connect those dots.

14:51 You just have to be literate.

14:52 On December 9th, 2025, two Indiana congressmen,

14:56 Rudy Yake and Andre Carson, introduced HR6509,

14:59 the so-called safeguarding Americans from fraudulent and experimental

15:02 drugs act or the Safe Drugs Act.

15:05 Sounds noble, right?

15:06 It's not.

15:07 The Alliance for Pharmacy Compounding described it as a mess

15:10 and said it was straight out of drug makers playbook.

15:12 It would impose severe restrictions on compoundingarmacies,

15:15 cap the number of compounds they can produce,

15:17 and dramatically expand FDA oversight and fees.

15:20 You think Rudy and Andre introduced that to help patients?

15:23 Let's recap some campaign contribution numbers.

15:26 In 2024, the pharmaceutical industry spent $391 million on federal lobbying.

15:32 In the first half of 2025 alone,

15:34 they dropped 227 million on pace to shatter the all-time record.

15:38 The Alliance for Pharmacy Compounding, the people that recognize compounders,

15:42 their entire lobbying budget, 200 grand.

15:45 It's not a fair fight.

15:46 It's a massacre.

15:48 Florida, California, and other states are passing similar legislation.

15:51 This is a coordinated nationwide campaign.

15:54 And if you think it's about your safety,

15:55 I have a bridge in Brooklyn to sell you.

15:57 But I haven't told you about the worst part yet.

16:00 Because this isn't just about numbers and legislation.

16:02 It's about real people.

16:04 People that I know, patients in my clinic.

16:07 I want to tell you why this fight is personal for me and why I care so much.

16:11 Because it's not abstract.

16:12 It's not just a policy debate.

16:14 These are my patients.

16:16 The wall above my desk is covered with birth announcements and baby pictures

16:20 of couples who are only able

16:21 to conceive due to compounded fertility medications.

16:24 The majority of whom, funnily enough,

16:26 voted to put this current administration into power.

16:29 If I didn't have access to compounded medications,

16:32 those children wouldn't exist.

16:34 Donald Trump described himself as the fertilization president.

16:37 So why is his administration decreasing

16:39 access to fertility medications that men need?

16:42 Because guess what?

16:43 There are no commercial fertility medications for men.

16:46 If this war continues, what do I tell the next man who walks through my door?

16:50 Sorry, the FDA has decided your family isn't worth protecting.

16:54 And I'll make it even more personal.

16:56 My wife and I went through IVF.

16:58 We know what it's like to need medications that cost thousands of dollars.

17:01 And we know what it's like when commercial options won't cut it.

17:04 Compoundingarmacies gave families like ours a chance.

17:07 One that big pharma is actively trying to rob from other couples.

17:11 Hey Merc, how many dollars is my son worth?

17:13 To you, the viewer, how many dollars is your family worth?

17:16 Because right now, the pharmaceutical industry has

17:19 put a price tag on your health, your well-being, and your reproductive future.

17:22 And they're lobbying to make sure that you

17:24 have no alternative but to pay their price.

17:27 The FDA's own mission statement says it is responsible

17:30 for protecting the public health by ensuring the safety, efficacy,

17:34 and security of human drugs and helping the public get the accurate

17:38 science-based information they need to use

17:41 medicines that maintain and improve their health.

17:44 How does referring HIMS to the DOJ for offering a $49

17:47 weight loss medication when the commercial

17:49 alternative cost $1350 advance affordability?

17:52 And how does banning compounded hCG,

17:54 forcing patients from a $50 vial to a thousand

17:57 plus commercial product anyone other than shareholders?

18:00 And how does suing the pharmacies that stepped up during a drug

18:03 shortage that pharmaceutical companies themselves caused

18:06 through insufficient manufacturing capacity advance public health?

18:09 The answer is it doesn't because the FDA

18:11 in this arena is not acting as a public health agency.

18:14 It's acting as an enforcement arm of the pharmaceutical lobby.

18:17 It's acting as a mob enforcer for Nova Nordisk and Eli Liy.

18:20 is using your tax dollars to protect

18:22 companies that generated over a hundred billion dollars

18:24 in combined GLP revenue while millions of Americans

18:27 went without medication because they couldn't afford it.

18:30 But why?

18:30 Why is this happening now?

18:32 And why would the FDA pursue policy that's diametrically opposed

18:36 to everything that was promised by leadership during their campaign?

18:39 I think something changed.

18:40 I think something tipped the scale and I think I figured out what it was.

18:44 Now, this is just a theory.

18:46 I'm talking conjecture based on circumstantial evidence and a timeline

18:49 that seems to line up a little too perfectly.

18:52 Now, I'm a scientist.

18:53 I deal in evidence.

18:54 So, let me just lay out the facts and you can decide for yourself.

18:57 December 4th, 2024, Mara Lago.

19:00 President-elect Trump hosts a three-hour dinner with Fiser CEO Albert Borla,

19:04 Eli Liy CEO David Ricks, Pharma head Steven U,

19:07 incoming chief of staff Susie Wilds, Dr.

19:09 Oz, and RFK Jr., the man who

19:11 once called pharmaceutical companies a criminal enterprise,

19:14 breaking bread with the CEOs of the two largest drug companies on Earth.

19:18 At Donald Trump's house, February 2025,

19:21 Pharma hosts a lavish summit in Washington.

19:23 Borla publicly says that the Trump administration

19:26 offers more opportunities than risk for drug makers.

19:28 And by September 30th, Trump is in the Oval Office shaking Borla's hand,

19:32 announcing the first Trump RX deal.

19:34 and Kennedy is standing behind them with a look on his face that I

19:37 can only describe as a man watching

19:39 his principles get auctioned off in real time.

19:41 Now, I want to be fair.

19:43 The price reductions that Trump RX has made possible are real.

19:46 It launched February 5th, 2026 with 43 drugs from 16 companies.

19:50 Ozimpic dropped from $1,28 to 350 a month.

19:53 WGOI from 1349 to as low as 199.

19:56 EMD Sereno cut IVF drugs up to 84%.

20:00 And these are meaningful numbers.

20:01 I'm not going to pretend otherwise,

20:02 but they're still exponentially more expensive than what compounding can offer.

20:06 Now, look at that timeline.

20:07 September 2025, the Fiser deal drops.

20:10 October through December,

20:11 enforcement against compounders escalates dramatically.

20:14 And in January 2026, the FDA finalizes its interim policy,

20:18 effectively banning ingredients under review.

20:20 And finally, in February, Trump RX goes live the same week Novo sues him

20:25 and the DOJ gets sicked on a company for selling a $49 pill.

20:29 I believe, and it's just a theory,

20:31 that the [snorts] Trump administration traded compoundingies for Trump RX.

20:34 Pharma lowered some prices.

20:36 They gave the president political win.

20:38 They helped him fulfill a campaign promise,

20:40 and we got a flashy government website with his name on it.

20:42 And in return, the administration delivered the regulatory

20:45 crackdown that big pharma has been lobbying

20:47 for since the day compounded simagludide started eating

20:50 into their revenue when they couldn't meet production capacity.

20:54 But here's the thing.

20:55 Even if Trump RX is real and the savings are real, it's not enough.

20:58 Ozimpic at 350 a month is still $4,200 a year.

21:02 Compounded simaglutide was $50 to $150 a month, $600 to $1,800 a year.

21:07 Even with Trump RX, patients pay $2 to7 times more.

21:10 And Trump RX doesn't count towards your deductible.

21:13 So Pharma gave Trump his headline.

21:14 And Trump, whether he meant to or not, gave Pharma its monopoly.

21:18 The compounders got squeezed out.

21:20 And the whole thing is being wrapped in a bow of patient safety.

21:23 But I didn't make this video just to tell you about the problem.

21:26 I made this video because I think I have the solution and I

21:29 want to deliver it directly to the people who can make it happen.

21:32 I want to speak directly to five people.

21:34 Secretary Kennedy, Commissioner Macker, Deputy Secretary O'Neal, Dr.

21:38 Brener, and Admiral Christine.

21:40 And through them to the president himself.

21:43 I'm not here to attack you.

21:44 I'm here to talk to you, doctor to public servants,

21:47 because I believe that you have the power to do something historic.

21:51 And I truly believe that you might actually want to.

21:54 I understand the pressure you're under.

21:55 Every decision you make has a dozen

21:57 stakeholders pulling you in different directions.

22:00 The pharmaceutical industry has more lawyers in your lobby

22:03 than you have staff in your offices.

22:04 And it probably seems like there's no way

22:06 to challenge a hundred billion dollar industry without political consequences.

22:11 I get it.

22:12 That's real.

22:13 But I'm going to ask you something and I want you to sit with it.

22:16 How can you make America healthy again while simultaneously allowing

22:20 the regulatory elimination of the affordable medications that make it possible?

22:24 And here's the good news.

22:25 You don't have to choose between Trump RX and compounding.

22:29 You can have both.

22:30 And if you do it right, you won't just lower drug prices.

22:33 You will fundamentally transform American healthcare.

22:36 So, let me tell you how.

22:38 Step one, let compounders compete.

22:41 Don't crush them.

22:42 Unleash them.

22:43 the free market that President Trump champions every single day.

22:47 Apply it to health care.

22:48 Compoundingarmacies are small businesses.

22:50 They employ American workers.

22:52 They pay American taxes and they serve American patients.

22:56 Destroying them to protect Fizer's profit margins is

22:58 the opposite of everything this administration says it stands for.

23:02 Step two, start with 503A compoundingies that have

23:06 a direct relationship with 503b outsourcing facilities.

23:09 And let me tell you why this matters.

23:12 [music] 503AIES are your traditional compoundingies,

23:14 state regulated patientspecific prescriptions.

23:17 503b outsourcing facilities are federally registered and subject

23:21 to FDA inspection under current good manufacturing practices.

23:24 A 503A pharmacy partnered with Inspectable 503b

23:27 facility gives you the best of both worlds.

23:30 Personalized medicine with federal quality oversight.

23:32 You want safety, there's your safety.

23:35 Step three, and this is a big one.

23:37 Add the drugs from those compoundingarmacies to Trump RX.

23:40 You already built the website.

23:42 You already built the infrastructure.

23:44 You're already directing patients to manufacturers direct to consumer platforms.

23:48 Why not add a tab for FDA inspected compounding facilities?

23:51 Let patients compare.

23:52 Brand name will go for $349 or compounded simlutide

23:56 from a 503A coupled with a federally inspected 503b for $120.

24:01 Let the patient decide.

24:02 That's not dangerous.

24:04 That's competition and that's capitalism.

24:07 Step four, reverse the biologics reclassification for products like HCG, FSH,

24:12 and HMG that have over 50 years of safe compounding history.

24:16 These drugs didn't become dangerous in March 2020.

24:18 The paperwork changed.

24:20 Fix the paperwork.

24:21 Step five, and I want every national security

24:24 hawk in the building to hear this one.

24:26 Expand the list of drugs that 503b outsourcing facilities are allowed

24:30 to compound and empower those facilities as a matter of national defense.

24:36 Right now there are 270 active drug shortages in American hospitals.

24:41 270.

24:42 The GAO found that nearly 60% of those shortages have lasted two or more years.

24:47 Cancer drugs like cisplatin and carboplatin have been

24:49 in shortage for much of the past 2 years.

24:52 One in 10 cancer patients have been affected by drug shortages.

24:55 One in 10.

24:56 And here's the national security angle that should terrify everyone.

25:00 The vast majority of our generic drug supply,

25:02 the active pharmaceutical ingredients,

25:04 the raw materials, the key starting materials, they come from China.

25:08 The FDA conducts about 12,000 domestic inspections per year.

25:12 But only 81 inspections in China as of May 2025.

25:16 81 in a country that supplies a massive portion of our pharmaceutical inputs.

25:20 And when they do inspect in China, they have to give advanced notice.

25:23 They can't do surprise inspections.

25:25 So manufacturing logs get altered, expired supplies get moved,

25:28 and access to key areas gets restricted.

25:31 The Department of Defense has acknowledged that is,

25:33 and I'm quoting their own testimony,

25:35 wholly dependent on the commercial market for pharmaceutical products.

25:38 A former Defense Health Agency official told the US

25:41 China economic and security review commission that Chinese dominance

25:45 of the global API market poses a debilitating risk

25:48 to domestic drug production if China ever decided to restrict deliveries.

25:52 During COVID, we ran out of contrast die,

25:55 the stuff you need for CT scans and MRIs.

25:57 Why?

25:58 Because the supply came from a single facility overseas.

26:01 We couldn't image our own patients in America.

26:04 Because we outsource our pharmaceutical supply chain to a geopolitical rival.

26:08 Now, imagine if instead of depending on Chinese

26:11 factories that the FDA can't properly inspect,

26:13 we empowered American 503b outsourcing facilities

26:17 to produce essential generic medications domestically.

26:20 You want to reshore manufacturing?

26:21 You don't need to convince Fizer to build a $70 billion campus.

26:24 You need to let the 350 plus FDA registered outsourcing

26:28 facilities already operating in this country scale up their operations.

26:32 That's not just healthc care policy.

26:34 That's national defense.

26:35 That's supply chain resilience.

26:37 And that's exactly the kind of American self-sufficiency

26:40 that President Trump talks about every single day.

26:43 Secretary Kennedy, on October 25th, 2024, you posted on X,

26:48 and I quote, "The FDA's war on public health is about to end.

26:52 This includes its aggressive suppression of psychedelics, peptides,

26:56 and stem cells." That post got 6.5 million views.

26:59 You said it again on the Gary Brea podcast in May

27:02 2025 that you would end the war at FDA on peptides.

27:06 Sir, hCG is a peptide.

27:07 FSH is a peptide.

27:09 Simaglutide is a peptide.

27:10 These are the medications that compoundingarmacies produce

27:13 and that your FDA is actively working to restrict.

27:16 You built your career on fighting pharmaceutical corruption.

27:20 You called these companies a criminal enterprise.

27:22 You promised to end the corporate capture of HHS.

27:25 Millions of people believed you.

27:27 I believed you.

27:28 This is your chance to prove that you meant it.

27:31 Will you follow through on what you promised 6.5 million people?

27:35 Commissioner Mackery, you spent 22 years at John's Hopkins.

27:38 You wrote The Price We Pay, a book about how the pharmaceutical industry

27:42 is breaking American healthcare with their pricing.

27:45 You took the hypocratic oath and you

27:46 were confirmed with bipartisan support because people

27:49 on both sides of the aisle believe that you would put patients over industry.

27:53 And right now, your agency is referring companies to the DOJ

27:57 for selling a $49 medication when the commercial alternative cost $1350.

28:02 That's the price.

28:03 And you wrote the book on why it's wrong.

28:06 You have the power to add compounded drugs to Trump RX.

28:09 You have the power to create a regulatory framework

28:12 that empowers 503A and 503b facilities instead of strangling them.

28:17 That's the legacy move.

28:19 Do what you've been saying for 20 years and put patients first.

28:22 Admiral Christine, this one is personal.

28:25 You're a urologist.

28:26 I'm a urologist.

28:28 We haven't spoken much since you took office,

28:30 but you were one of my first mentors, and I still consider you my friend.

28:33 You're a member of the AUA and the Sexual Medicine Society of North America,

28:37 the same organizations that I belong to.

28:40 You understand better than almost anyone in government what compounded hCG,

28:45 FSH, and Enclophine mean for male patients.

28:48 And you've seen what happens when

28:49 men lose access to fertility preserving medications.

28:52 Every day this crackdown continues.

28:54 There are patients in clinics across America who are being told there is

28:58 no affordable option for the medication that would let them start a family.

29:02 But you can change that.

29:04 Dr.

29:05 Brener, you've served under multiple administrations.

29:08 You were the acting commissioner before Mackery was even confirmed.

29:11 You understand the FDA from the inside, its capabilities, and its blind spots.

29:15 You, too, took the hypocratic oath.

29:17 Your institutional knowledge is irreplaceable right now.

29:20 And patients caught in this crossfire need someone inside the building

29:24 who remembers why the FDA exists in the first place.

29:27 The 503b framework was designed to create a safe,

29:30 inspectable middle ground between

29:32 traditional compounding and commercial manufacturing.

29:34 Use it, strengthen it, don't weaponize it.

29:38 Deputy Secretary O'Neal,

29:39 you've spoken publicly about making healthc care affordable and accessible.

29:44 In 2014, you advocated for the FDA to approve

29:47 drugs after demonstrating safety with efficacy proven postmarket.

29:51 A radical proaxis position.

29:53 You understand that the current system is designed

29:56 to benefit incumbents at the expense of patients.

29:59 How does that philosophy square with referring a company

30:02 to the DOJ for selling a $49 medication?

30:05 The national security argument I just

30:07 made reshoring pharmaceutical manufacturing through 50B empowerment.

30:10 That's your wheelhouse.

30:12 You came from Silicon Valley.

30:13 You understand supply chain risk.

30:16 Make the case inside the building that the rest

30:18 of us are trying to make out here.

30:20 President Trump called himself the king of IVF.

30:23 He signed an executive order in February

30:25 2025 specifically to expand access to fertility treatments.

30:29 He signed another in November called Fostering

30:31 the Future for American Children and Families.

30:34 Vice President Vance stood at a podium and said,

30:36 "I want more babies in the United States of America."

30:40 This administration has staked its legacy

30:42 on helping American families have children.

30:46 But right now, right now,

30:47 the regulatory apparatus under your control is doing the opposite.

30:51 It's eliminating affordable fertility medications for men.

30:54 It's suing thearmacies that provide them.

30:56 It's referring companies to the DOJ for making treatments accessible.

31:00 You're closing the door that patients were already walking through

31:03 and then asking them to be grateful for a window.

31:06 I'm not asking you to be anti-farma.

31:08 I'm asking you to be propatient and I'm not asking you to dismantle the FDA.

31:13 I'm asking you to use it the way it was intended to protect Americans,

31:18 not pharmaceutical profit margins.

31:20 This is a generational opportunity.

31:22 No administration in history has ever

31:24 had the political leverage, the public mandate,

31:27 and the infrastructure already in place to do what I'm describing.

31:30 You have Trump RX.

31:31 You have the executive authority.

31:33 You have a secretary of HHS who

31:35 built his entire career railing against pharmaceutical corruption.

31:39 And you have a president who has proven he's willing to use tariffs,

31:42 executive orders, and sheer force of personality

31:45 to bend an entire industry to his will.

31:48 And you have an American public that is desperate,

31:51 desperate for someone to put patients ahead of profit.

31:54 Let compounders compete.

31:56 Add them to Trump RX.

31:57 Reverse the biologics reclassification.

32:00 Empower 503b facilities as a matter of national security.

32:04 Do that and you won't just be

32:06 remembered as the administration that lowered drug prices.

32:08 You will be remembered as the greatest

32:10 advocates for American healthcare that ever held office.

32:14 Period.

32:14 Full stop.

32:15 And all you have to do is stop letting pharmaceutical lobbyists write the rules.

32:20 Choose patients.

32:22 Choose families.

32:23 Choose compounding.

32:24 Choose the oath that three of you took.

32:26 The first that says do no harm.

32:28 Your character is stronger than any weight a pharma lobbyist can bring to bear.

32:32 I am not some anti-farma crusader with an axe to grind.

32:36 I'm a doctor.

32:37 I prescribe commercial pharma products every day.

32:40 And many of them genuinely save lives.

32:42 I believe in Nova Nordis and Eli Lily science.

32:44 I believe GLP-1s are transformative medications,

32:47 but believing in the science and believing that companies should be

32:50 allowed to use regulatory capture

32:52 to eliminate competition and price gouge patients,

32:55 those are two very different things.

32:57 You can support pharmaceutical innovation and still

32:59 demand that patients have access to affordable alternatives.

33:03 These positions are not mutually exclusive,

33:05 and anyone who tells you they are is trying to sell you something.

33:08 I took the hypocratic oath, too.

33:10 And that oath doesn't have a carveout for pharmaceutical revenue projections.

33:14 Now, do I actually think President Trump

33:16 or Secretary Kennedy will see this video?

33:18 No, I don't.

33:19 I'm a urologist in Indianapolis with a small

33:21 YouTube channel and a nicotine habit.

33:23 I'm not exactly in the Oval Office's media rotation.

33:26 But maybe someone who works for them will see it.

33:29 Maybe an aid, a policy adviser or a reporter.

33:31 Maybe they'll forward a link.

33:33 Or maybe even an influencer with a bigger platform

33:35 will pick this issue up and run with it.

33:37 Maybe a senator will think, "Huh,

33:39 this redneck penis doctor has a point." Because when it comes to big pharma,

33:43 there are more of us than there are of them.

33:45 A lot more.

33:46 They spent 391 million on lobbying last year.

33:50 A record.

33:50 They have armies of lawyers and lobbyists.

33:52 But you know what we have?

33:54 We have each other.

33:55 We have our voices.

33:57 And we have the truth.

33:58 My father is a veteran who deployed

34:00 to Afghanistan and depends on compounded medications.

34:03 And he taught me something as a kid that I'll never forget.

34:06 He said that all evil needs to prevail is

34:08 for good men to stand by and do nothing.

34:10 And if we stand by, if we let

34:13 big pharma choke off patients access to compounded medications,

34:16 if we watch quietly from the sidelines while 50 years of safe,

34:20 affordable, and accessible medicine gets dismantled just

34:23 so Novon Nordis stock price can recover, then evil will have won.

34:27 But I refuse to let that happen.

34:29 I refuse because I took an oath to put patients first.

34:31 And I meant it.

34:32 So if you're still with me, here's what I need from you, the viewer.

34:35 And I'm dead serious about this.

34:37 Call your state representatives.

34:39 Tell them you oppose legislation that restricts compounding pharmacy access.

34:43 If you're in Indiana, tell them to vote no on SB282.

34:47 And if you're anywhere in the US,

34:48 tell your federal representatives to oppose the Safe Drugs Act, HR6509.

34:53 Like this video.

34:54 I know every YouTuber says that, but the algorithm is real.

34:57 And likes tell YouTube to show this to more people.

35:00 More people means more voices.

35:02 More voices mean more pressure.

35:04 That's how this works.

35:05 Comment below.

35:06 Tell me your story.

35:08 Are you a patient who lost access to compounded hCG?

35:11 Do you get your TRT from a compounding pharmacy?

35:13 Are you a woman paying thousands for fertility drugs that used to be affordable?

35:17 Or maybe you're a doctor watching your patients suffer because the medications

35:21 they need are locked behind a regulatory wall built by pharmaceutical lobbyists.

35:26 I want to know because your story matters

35:28 and the people making these decisions need to hear it.

35:31 Share this video.

35:32 Send it to everyone you know.

35:34 Post it on X, Facebook, Instagram, Reddit, Tik Tok, LinkedIn.

35:37 I don't care where.

35:38 Send it to your doctor.

35:40 Send it to your pharmacist.

35:41 Send it to your state representative.

35:43 Send it to your congressman.

35:44 Send it to every journalist who has ever written about drug pricing.

35:48 The more people who see this, the harder it becomes to ignore.

35:51 And subscribe.

35:52 I normally don't like begging for subscribers,

35:55 but I'm going to ask right now because I want this channel to be

35:58 a voice for patients who are being steamrolled

36:00 by the most powerful industry on the planet.

36:02 And that voice only matters if it's loud

36:04 enough for the people empowered to hear it.

36:06 And every subscriber makes that louder.

36:08 I'm one doctor in Indiana with 11 milligram Zens imported from Europe.

36:15 But I refuse to be silent while pharmaceutical

36:17 companies buy the regulatory machinery of the United

36:20 States government and use it to price patients

36:23 out of the medications they need to thrive.

36:25 I refuse to sit by and do nothing.

36:28 And I don't think you're okay with sitting this one out either.

36:31 So don't do something and start right now.

36:34 This is Dr.

36:34 Alex Tatum.

36:36 Thank you for watching and I'll see you in the next one.