CNBC Special Report: How Soaring U.S. Drug Prices Fueled What Feds Call An Illegal Import Of Medications 11/27/25

Summary

Podcast Summary: CNBC Special Report

Episode: How Soaring U.S. Drug Prices Fueled What Feds Call An Illegal Import Of Medications
Air Date: November 27, 2025
Host: CNBC’s investigative team, including Melissa Lee

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Overview

This episode investigates the explosive growth of Alternative Funding Programs (AFPs) supplying Americans with cut-rate prescription medications sourced from overseas, despite federal laws prohibiting the importation of such medicines. Driven by soaring U.S. drug prices, these gray-market channels have become lifelines for desperate patients and cash-strapped employers, but experts and officials warn that these practices are illegal and potentially life-threatening.

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Key Discussion Points & Insights

1. The Skyrocketing Cost of U.S. Prescription Drugs

• U.S. drug prices average nearly three times more than those in other developed countries, pushing patients and employers into financial strain.

  “With some specialty medications costing tens or even hundreds of thousands of dollars per year… prescription drug prices in the U.S. averaging nearly three times more than in other countries…” (01:13-01:29)

• Personal stories highlight desperation:

  • Bruce Zimmerman, MS patient:

    "It's a desperate thing to think that you might not have your medication at all." (01:29-01:34, 17:32-17:42)

2. The Rise and Risks of Alternative Funding Programs (AFPs)

• AFPs act as a workaround: They buy specialty drugs from abroad at a fraction of U.S. prices, then distribute them to patients—often without patients’ full understanding or explicit consent.

  • Greg Santuli, CEO of Rx Valet:

    “We do a public service, we help people get access to medications…” (01:42-01:44, 30:55)

• But the legality is murky:

  “…what they're doing is illegal and it's putting American lives at risk.” (Nicole Johnson, Homeland Security Special Agent, 01:48-01:52)

• Risks of counterfeit/dangerous drugs:

  “Every time you’re taking a foreign medicine that’s been delivered from overseas, you’re playing a game of Russian roulette.” (Lori Mayal, Gilead Sciences, 02:43-02:50)

3. How AFPs Function—and Circumvent Oversight

• Employers, including cities and school districts, under financial pressure, carve out expensive drugs from standard coverage and push employees into AFPs.

  • Sometimes patients are forced to use these programs or pay full price without coverage.

    “It's no choice at all. Patients are put in an impossible position..." (06:14-06:19)

• Drug origins are often unclear: Medications labeled as from Canada may actually transit through countries like Turkey, India, or Australia, increasing risk.

  “You don’t actually know if that medicine truly came from Canada.” (05:23)

• Evasive distribution tactics: Prescriptions are shipped directly to consumers, bypassing U.S. customs and regulatory checks.

  “This is a way for them to evade customs and being detected by law enforcement.” (Nicole Johnson, 07:38-08:13)

4. The Legal Debate and Regulatory Response

• AFPs' legal defense: They claim to operate under personal importation policy (small-scale importation for personal use).

  “They are operating legally under the FDA's personal importation policy, a narrow exception that lets individuals get medications from abroad for personal use.” (08:44)

• FDA and former officials refute these defenses:

  • Leigh Verbois, ex-FDA Director:

    “What AFPs are doing are importing misbranded and unapproved foreign drugs, which is illegal... There’s no gray area when the product is approved in the United States... there is not a gray area.” (10:57-12:02)

• Homeland Security’s position: Patients are considered victims, not perpetrators; responsibility falls on AFPs.

  “We are viewing our patients in the United States as victims of these crimes... the company itself is the criminal...” (Nicole Johnson, 18:35-18:52)

5. Patient Story: Luxury Medical Junkets

• Bruce and Becky Zimmerman described being sent on all-expense-paid trips to pick up medications in the Cayman Islands and Bahamas via Price MDS.

  "I went to the Cayman Islands four times. Bruce went five. And then we went to Bahamas and we did that three times." (14:19-14:29) “If I’d have been told that, I’d say, send me the tickets, I’ll go again.” (17:17-17:29)

• Drug supply chain shown to be unauthorized: Biogen (maker of Avonex) confirms these channels are not legitimate.

  “Biogen... told us this route is not part of Biogen’s authorized supply chain…” (15:06)

6. AFPs’ Contracts Shift Liability to Patients

• Contracts require patients to assume all responsibility, attempt to release AFPs and employers from liability.

  “It seems like the patient is saying, 'I'm assuming all liability here.'” (18:14) “That's the scheme... So even if they write this in a contract, that doesn't mean that they're not violating U.S. federal and state laws.” (Nicole Johnson, 18:18)

7. Industry Pushback and Ongoing Legal Play

• Companies like Canorex claim their practices are legal and safe, and that U.S. regulators are wrong or misinterpreting policy.

  “Built into my client’s program are the safety precautions that ensure that the medicine is real, that it’s coming through a legitimate supply chain...” (Canorex General Counsel, 20:55) “On behalf of the patient, I will say boldly those regulators are wrong.” (Canorex General Counsel, 22:05)

• FDA and Leigh Verbois dispute:

  "That is not what is meant by that handbook… Absolutely not.” (Leigh Verbois, 22:48-22:53)

• Litigation in progress: Gilead filed lawsuits to block these flows, obtaining injunctions against various parties.

8. The Human Impact: Desperation vs. Safety

• Patients left with impossible choices: For many, using AFPs is the only feasible route to their medications.

  "For others, it’s a matter of using an AFP or not getting their prescription at all." (24:22)

• Advocacy organizations push back:

  "The biggest concern is the patient is the pawn here.... Why are we making individuals with a life-threatening disease, chronic illness, be the guinea pigs for something that we thus far have said is not the way we’re going to go in US Healthcare..." (Mary Dwight, Cystic Fibrosis Foundation, 33:45-34:48)

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Notable Quotes & Memorable Moments

• "Every time you're taking a foreign medicine that's been delivered from overseas, you're playing a game of Russian roulette."
  – Lori Mayal (Gilead Sciences), 02:43

• "What AFPs are doing are importing misbranded and unapproved foreign drugs, which is illegal."
  – Leigh Verbois (Former FDA Director), 10:57

• "We are viewing our patients in the United States as victims of these crimes. This company is providing them with illicit pharmaceuticals. And so we would consider that the company itself is the criminal in this scenario, not the patient."
  – Nicole Johnson (Homeland Security Special Agent), 18:35

• “When it comes to prescription medicines, prioritizing cost over quality is dangerous.”
  – Lori Mayal, 27:46

• "I have no comment."
  – Greg Santuli (CEO of RX Valet), challenged on legal compliance, 30:48

• "It's such a desperate thing to think that you might not have your medication at all."
  – Bruce Zimmerman, multiple instances (01:29, 17:32)

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Timestamps for Important Segments

• US Drug Pricing Crisis – 01:02-01:29
• AFPs Explained & Patient Risk – 01:34-02:50
• Legal/Regulatory Overview (FDA, Homeland Security) – 06:41-11:45
• Patient Story: Medical Tourism for Drugs – 12:38-17:32
• AFPs Contracts & Liability – 17:42-18:52
• AFPs' Defense vs. FDA’s Stance – 18:57-23:01
• Litigation and Enforcement – 23:01-24:22, 28:09-32:09
• Patient/Advocacy Perspective – 33:38-34:48

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Conclusion

This CNBC special paints a vivid, unsettling picture of how surging U.S. drug prices, paired with a fractured healthcare and regulatory system, have fostered a dangerous gray market of potentially illegal drug imports. Patients and employers, desperate for relief, are drawn into shadowy arrangements that may compromise their safety and legal standing.

Experts urge greater transparency and enforcement. The bottom line: until the U.S. drug pricing crisis is addressed, patients face an impossible choice—risk foreign, potentially unsafe medicines, or go without lifesaving treatments.

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Transcript

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A question being asked across the country how can I afford my prescription drugs? Prices are skyrocketing.

[Interviewer/Investigator]

It's a broken system and we need to make sure everyone is paying attention.

[Narrator/Reporter]

With some specialty medications costing tens or even hundreds of thousands of dollars per year and prescription drug prices in the U.S. averaging nearly three times more than in other countries, driving people and employers to find a solution, it's such a.

[Patient (Bruce Zimmerman)]

Desperate think that you might not have your medication at all.

[Narrator/Reporter]

A booming cottage industry is selling itself as an antidote, often getting the drugs overseas for a fraction of the cost.

[Greg Santuli (CEO of RX Valet)]

We do a public service, we help.

[Narrator/Reporter]

People get access to medications, but there's a major catch.

[Nicole Johnson (Homeland Security Special Agent)]

What they're doing is illegal and it's putting American lives at risk.

[Leigh Verbois (Former FDA Director)]

What I tell my friends and family is that the most expensive medicine that they could get is one that isn't.

[Narrator/Reporter]

Safe, patients and employers are desperate for a solution. The question is at what cost? The FDA says it's illegal to import.

[Interviewer/Investigator]

Drugs that are available and sold in the United States. All of these drugs are in fact available domestically, correct?

[Narrator/Reporter]

Imagine opening up your mail, expecting your life saving medication and getting this all in Turkish. The HIV drug Biktarvy, originating from this pharmacy in Istanbul and shipped to the United States via what's known as an alternative funding program or afp, which buys high cost specialty drugs from abroad for a fraction of the price in the us.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

Every time you're taking a foreign medicine that's been delivered from overseas, you're playing a game of Russian roulette.

[Narrator/Reporter]

Lori Mayal is in charge of anti counterfeiting and product security at Gilead Sciences, which manufactures Biktarvy. When you first learned about this case.

[Interviewer/Investigator]

Did you think this was a one off?

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

That's what we were hoping because we knew that it was very dangerous for patients to be receiving foreign medicines from overseas. They're unregulated, they're coming from unknown sources.

[Narrator/Reporter]

But this is not an isolated incident. These AFPs are targeting cash strapped employers and their employees like teachers, police officers and retirees from places like rural Lebanon, Missouri to small towns in upstate New York. These employers typically don't have traditional insurance and pay health care costs out of pocket.

[Interviewer/Investigator]

So they carve out coverage of expensive specialty drugs for illnesses like cancer or.

[Narrator/Reporter]

Ms. That can cost hundreds of thousands of dollars a year.

[Interviewer/Investigator]

AFPs save them money by buying lower cost drugs from overseas. And AFPs make money by charging fees or taking a percent of the savings.

[Narrator/Reporter]

Patients get the drug for little or no cost. AFP say they're an answer to a broken health care system. And what they're doing is legal, connecting.

[Interviewer/Investigator]

Employees directly with cheaper drugs overseas. But regulators say what they're doing is wrong.

[Narrator/Reporter]

As part of our investigation, we submitted nearly 100 public records requests that show private employers, cities, counties, school districts and unions are using AFPs. And we obtained more than 10,000 pages of documents, including contracts, emails, invoices and complaints. Not all AFPs import medicines, but the ones that do promise outsized savings. So it's easy to see why they're growing in popularity.

[Interviewer/Investigator]

It's a sales pitch on the backs of the safety of the patients. Patients take a safety hit in order.

[Commercial Announcer]

To save an employer money.

[Narrator/Reporter]

Shabir Imber Safdar is the executive director of the Partnership for Safe Medicines, a coalition of non profit and pharmaceutical industry groups that protect consumers against unseen. He's been investigating AFPs for the past two years.

[Interviewer/Investigator]

We have uncovered about $5 million just in the last two years of illegally imported unsafe medicine that patients have been given. $5 million.

[Commercial Announcer]

Yes, medicine that was never reviewed by.

[Interviewer/Investigator]

The Food and Drug Administration.

[Narrator/Reporter]

Many AFPs we analyzed said their medications were coming from countries like the UK, Australia and Canada.

[Interviewer/Investigator]

Why so many of these AFPs have been able to infiltrate, so to speak, so many different employee health plans and county health plans. They think, oh, Canadian medicine is safe.

[Commercial Announcer]

But you don't actually know if that medicine truly came from Canada.

[Narrator/Reporter]

For example, Safdar says he found medication from this Canadian pharmacy wasn't always coming from Canada. In the fine print, the pharmacy's website says we also have options to dispense your medications from our international fulfillment centers around the world, including the uk, Australia, New Zealand, Turkey and India. The pharmacy declined to comment. What if patients want to opt out? Sometimes employers don't give them a choice. Emails we obtained show the city of Lebanon, Missouri told its staff that their medications must be obtained through an AFP called Sharks, based in St Louis, Missouri. Otherwise their high cost medication will no longer be covered and they will be required to pay the full price. The city declined to comment.

[Interviewer/Investigator]

It's no choice at all. Patients are put in an impossible position and it's a crime that they're still.

[Commercial Announcer]

Paying health care premiums and yet they.

[Interviewer/Investigator]

Are not getting FDA approved medicine, legal.

[Commercial Announcer]

Medicine or safe medicine.

[Narrator/Reporter]

In a statement, Sharks told us Americans pay on average three or four times more than the rest of the world for their prescription drugs and added that we help employees access the medications they need when their medications are not covered by insurance.

[Nicole Johnson (Homeland Security Special Agent)]

No patient, no American should ever have to be forced to take medication that's going to put their life at risk.

[Narrator/Reporter]

We learned that the Department of Homeland Security has launched several criminal investigations into AFPs. Nicole Johnson is a special agent with Homeland Security Investigations who manages the pharmaceutical program at the department's National Intellectual Property Rights Coordination Center.

[Nicole Johnson (Homeland Security Special Agent)]

A lot of these AFPs are going to target lower income, lower paying jobs. This is going to be a school district, a county government, a religious organization where there's not a lot of money in excess for health benefit plans. So if you only have $500,000 to spend a year and you can save a couple hundred thousand dollars, you could use that money elsewhere.

[Interviewer/Investigator]

So they are really preying on those that are the most vulnerable in the system.

[Nicole Johnson (Homeland Security Special Agent)]

Absolutely.

[Narrator/Reporter]

Johnson revealed what the ongoing investigations uncovered about how most AFPs operate.

[Nicole Johnson (Homeland Security Special Agent)]

What we've discovered is these alternative funding programs are fulfilling prescriptions through unverified suppliers and online pharmacies. Potentially illicit, and they're not actually importing the drugs themselves. So the prescriptions are getting mailed directly to the patients. Therefore, customs has no idea how many prescriptions have made it to US Citizens, how many have come from verified places and this is a way for them to evade customs and being detected by law enforcement.

[Interviewer/Investigator]

So we really just don't know.

[Nicole Johnson (Homeland Security Special Agent)]

We have no idea what's wrong with.

[Interviewer/Investigator]

Receiving medicines from overseas, especially if they are from Europe or Canada. Isn't that safe?

[Nicole Johnson (Homeland Security Special Agent)]

Not necessarily. The United States has very strict laws and regulations that are intended to protect patients. So there's rigorous testing, there's supply chain security that's been put in place, pharmaceuticals that are intended for another country may not have the same safety standards that the United States has, Johnson says.

[Narrator/Reporter]

AFPs typically argue they're operating legally under the FDA's personal importation policy, a narrow exception that lets individuals get medications from abroad for personal use. When we asked the FDA specifically if personal importation covered the practices of AFPs, it told us in most circumstances a person cannot import prescription drugs from other countries into the US as substitutes for FDA approved drugs, and that medicines from outside the legitimate US Drug supply chain do not have the same assurance of safety, effectiveness and quality as drugs subject to FDA oversight.

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[Narrator/Reporter]

If anyone knows all about the FDA and AFPs, it's Leigh Verbois. She spent nearly 23 years at the FDA, the last five as director of the Office of Drug Security, Integrity and Response. She left the agency earlier this year and this is the first time she's publicly speaking out about AFPs.

[Leigh Verbois (Former FDA Director)]

What AFPs are doing are importing misbranded and unapproved foreign drugs, which is illegal.

[Interviewer/Investigator]

Full stop.

[Nicole Johnson (Homeland Security Special Agent)]

Full stop.

[Narrator/Reporter]

She says the FDA's personal importation policy doesn't allow what AFPs do.

[Leigh Verbois (Former FDA Director)]

The policy is such that it allows for very exceptional instances for importation of products when an individual cannot obtain a product that is approved in the United States States. So if it's not approved or available clinically in the US an individual can obtain a product from a foreign Source assert that they are importing that product for themselves and then bring that product under a limited supply of 90 days into the United States and that product cannot be commercially brought into the US.

[Interviewer/Investigator]

So in an instance in which a patient is receiving by mail a drug that is approved for for use in the United States, but the drug is coming from outside the United States, is there any circumstance under which that is legal? No, there's no gray area here.

[Leigh Verbois (Former FDA Director)]

There's no gray area when the product is approved in the United States and they are being commercially purchased and brought into the United States. There is not a gray area.

[Interviewer/Investigator]

Do you think patients are aware of this practice? That there's something wrong with it, that there it may not be legal or allowed?

[Leigh Verbois (Former FDA Director)]

I don't think that the average patient understands that the products that they're getting are not FDA approved. And I don't think the average patient understands the complicated nature of the distribution practice that's happening.

[Patient (Bruce Zimmerman)]

Another beautiful day.

[Narrator/Reporter]

Bruce Zimmerman is one of those patients. A Florida based AFP called Price MDS has taken foreign importation one step further, according to documents we reviewed, going so far as sending patients to the Cayman Islands and Bahamas on all expense paid trips so they can pick up their medications themselves. Bruce and his wife Becky took several of these luxury trips courtesy of price MDs between 2019 and 2021. We interviewed them about the program near their home in St. Helena Island, South Carolina.

[Interviewer/Investigator]

Let's talk about why we're here. Bruce, when were you diagnosed with multiple sclerosis?

[Patient (Bruce Zimmerman)]

2017 was the official word from the doctor.

[Interviewer/Investigator]

How has life changed since that diagnosis?

[Patient (Bruce Zimmerman)]

It's a lot harder. Just walking a set of stairs is an obstacle for me. It's not just an inconvenience. I worry about falling.

[Narrator/Reporter]

He says his boss told him about Price mds, an optional program the company was offering.

[Patient (Bruce Zimmerman)]

They stress that to me. It's the exact same medication that I was taking at the time.

[Interviewer/Investigator]

When you heard about this program from your boss and you go home to Becky and you tell her about it, what was your reaction? Is this even legal? That was my first thought.

[Narrator/Reporter]

Despite their initial hesitation, the couple took multiple all expense paid trips. After the first one went off without.

[Patient (Bruce Zimmerman)]

A hitch, we tried to take in all that we could. We went swimming with stingrays. We went to Starfish Point. You know, I went scuba diving. I got a license so I could scuba dive and then took three scuba diving trips. It's just there's so much to do.

[Interviewer/Investigator]

And how many times did you do this? I went to the Cayman Islands four times. Bruce went five. And then we went to Bahamas and we did that three times.

[Narrator/Reporter]

And each time they would bring back a free three month supply of Avonex, the medication Bruce took for his multiple sclerosis, which currently retails for more than $2,100 per weekly dose.

[Patient (Bruce Zimmerman)]

When it was up time to call him, get another flight.

[Narrator/Reporter]

Based on what you saw, do you.

[Interviewer/Investigator]

Still believe that the medicine that you received would be the same as if you walked down the street to the pharmacy here? I. Yep.

[Patient (Bruce Zimmerman)]

And the first time I got the medication, I looked at it just to make sure, and it was exactly the same stuff, same plant, everything, same packaging.

[Narrator/Reporter]

But Turkish customs data we analyzed show that Price MDS has previously rerouted shipments of Avonex meant for one country or market and sold it through unauthorized channels. The data show that from 2020 to 2023, around the same time Bruce and Becky were making these trips, Price MDS sourced Avenex, originating in Germany, which passed through customs in Turkey via a Turkish exporter, then made its way to the Cayman Islands, Bahamas, Switzerland or the United States. Biogen, the manufacturer of Avonex, told us this route is not part of Biogen's authorized supply chain and that it does not have any direct customers or shipped to locations in either the Cayman Islands or Bahamas. The company added it condemns any illegal trade in pharmaceutical products and Avenex is just part of the picture. Since 2020, Turkish customs data also shows Price MDS has imported more than 1,200 drugs valued at more than $2.7 million to various countries. And that's just the drugs that can be traced through Turkey. Price MDS declined to comment on this story. Does that concern you at all?

[Interviewer/Investigator]

That the drug may be coming from a place it's not supposed to be coming from? And I would want to dive a little deeper into that. I see your wheels turning in your head, Becky. Well, because I'm thinking, okay, I can easily say, well, it doesn't concern us now because we're not in that program, but there are people that are still in that program and I would be concerned.

[Narrator/Reporter]

For today, Bruce no longer uses price MDs. He left the employer that offered it after his Ms. Progressed to the point where he couldn't do his job anymore. Now he says his new insurance doesn't consistently cover the medication he needs. When we talked to the special agent.

[Interviewer/Investigator]

We were discussing this because there's an investigation into these types of programs, and essentially she said that these kinds of programs have found a loophole because if those drugs were Shipped directly to the United States, that would be illegal and customs would seize them. But here they have people go abroad and pick up the drugs themselves.

[Patient (Bruce Zimmerman)]

I'm in danger of not having any of my medication at all. At least then I had the medication. And at one point, you don't care if it's illegal. If I'd have been told that, I'd say, send me the tickets, I'll go again.

[Interviewer/Investigator]

So legal or not legal, you do it again?

[Patient (Bruce Zimmerman)]

Yes, if I was faced with it, I would do it again. It's such a desperate thing to think that you might not have your medication at all.

[Narrator/Reporter]

In some contracts, AFPs appear to be transferring blame to the patient, like this one from Canada based AFP CanadaRex. Patients are required to agree they have purchased my medications internationally for personal use and that title to my medication passes to me. Or when my medications are shipped, it goes on to say patients must release the plan holder, its officers, employees, agents, heirs from any and all causes of actions with respect to errors or omissions by Canorex.

[Interviewer/Investigator]

It seems like the patient is saying, I'm assuming all liability here.

[Nicole Johnson (Homeland Security Special Agent)]

And that's the scheme is they are trying to avoid being held responsible for this. So even if they write this in a contract, that doesn't mean that they're not violating U.S. federal and state laws.

[Narrator/Reporter]

But Johnson says the responsibility falls on the afp, not the patients.

[Nicole Johnson (Homeland Security Special Agent)]

We are viewing our patients in the United States as victims of these crimes. This company is providing them with illicit pharmaceuticals. And so we would consider that the company itself is the criminal in this scenario, not the patient.

[Narrator/Reporter]

Canarex general counsel Joseph Morris told us his company is following the law.

[Interviewer/Investigator]

The FDA says it's illegal to import drugs that are available and sold in the United States.

[J]

I don't think that's what the handbook means. But understand it's a handbook as opposed to a regulation. It's a handbook that's meant to guide the exercise of discretion by FDA officials. And I do think that there are ambiguities built into that too. Because what makes a medicine available if.

[Interviewer/Investigator]

You can't afford it, Specifically the quote, is that the policy, personal importation, applies if the effective treatment may not be available domestically. All of these drugs are in fact available domestically, correct?

[J]

Well, a, what if they are available domestically? What if, B, they're not available to you, but the treatment is available to you? If you crossed the bridge from Detroit to Windsor and walked into a drugstore in Windsor and there's the medicine, the same medicine you could buy across the Bridge in downtown Detroit and there it is in Windsor, substantially lower price.

[Interviewer/Investigator]

So you're interpreting available as affordable if.

[J]

That'S a factor in availability. Absolutely, to be sure.

[Narrator/Reporter]

Morris also cites this law that says the Department of Health and Human Services may grant a waiver to individuals on a case by case basis for the importation of a prescription drug. Annie says since Canrx contracts directly with the patient, it's the patient who chooses to accept an imported drug.

[J]

That's the business that Canorex is in. It assists individual American consumers in exercising their right of personal importation, bringing their product to the border and asking the United States government at the border to adjudicate the lawfulness and appropriateness of their personal importation of the product.

[Narrator/Reporter]

And drug safety is a top priority. Morris says Canorex has never had one instance of a counterfeit drug slipping through. In fact, it advertises the highest safety standards and that the medicine shipped to US patients comes from highly regulated tier one countries like Canada, the UK and Australia.

[J]

Built into my client's program are the safety precautions that ensure that the medicine is real, that it's coming through a legitimate supply chain, that it's coming from a recognized manufacturer, that it is what the patient's doctor is ordering be delivered to that, to that patient.

[Narrator/Reporter]

But one document we obtained shows the FDA was concerned about a possible fake. In 2023, it emailed a Canorex patient who was receiving a menopause gel. The FDA wrote it sees the medication for being potentially misbranded counterfeit and said the patient does not qualify to receive this medication under the personal importation policy.

[Interviewer/Investigator]

Does this happen often?

[J]

It happens probably several times a quarter sometimes. I will advise the individual patient who's made the order how to contact the customs service or whoever is the relevant agency and say, here's who I am, here's what this is. Please deliver my medicine. And most of the time these things are resolved happily.

[Interviewer/Investigator]

If there are so few seizures or interceptions, why are the ones that are in fact intercepted? Why do they say that the patient is not qualified to receive it?

[J]

What makes a difference on behalf of the patient? I will say boldly those regulators are wrong.

[Narrator/Reporter]

In 2019, Canorex also received a warning letter from the FDA for importing drugs from abroad by operating in a manner that substitutes the FDA approved drugs prescribed by the US healthcare provider with unapproved drugs. Morris says Canorex responded to the FDA in this document that the FDA's description of Canorex and its business model is, is incorrect, but did agree to stop importing drugs which require a doctor to administer. The FDA told us it could not comment about ongoing compliance issues. Verbois says Morris interpretation that the agency has discretion is flat out wrong.

[Leigh Verbois (Former FDA Director)]

That is not what is meant by that handbook.

[Interviewer/Investigator]

Absolutely not.

[Leigh Verbois (Former FDA Director)]

Absolutely not.

[Interviewer/Investigator]

So it's not just up to the FDA official to decide whether or not this is is okay. It is not okay in any circumstance.

[Narrator/Reporter]

No, Canorex is not the only AFP on regulators radar. In March 2023, the FDA sent a warning letter to ElectRx in health solutions, an AFP based in Ohio. The FDA letter said its drug importation program from overseas poses significant health risks to US Consumers. The company responded that its personal importation of medicines was legal. Despite the warning, electrX this year was still offering medication from overseas through its personal importation program. The company declined to comment on these practices and took its website offline after we reached out for comment. The FDA has not taken further action.

[Interviewer/Investigator]

Do you think these AFPs should be shut down?

[Nicole Johnson (Homeland Security Special Agent)]

I do think they should be shut down because what they're doing is illegal and it's putting American lives at risk. It could kill a patient in the.

[Narrator/Reporter]

Meantime, the House Appropriations Committee in June said it has deep concern over the health risks posed by illegal importation of unapproved and misbranded drugs, particularly through AFPs. Given these significant dangers, the committee directed the FDA to provide a comprehensive report on how to strengthen oversight. But for many, using AFPs are the only way to deal with sky high healthcare costs. As part of our investigation, we spoke to more than a dozen patients.

[Interviewer/Investigator]

And for these employees, from teachers to police officers to retirees, many told us using an AFP is convenient and saves them money. And for others, it's a matter of using an AFP or not getting their prescription at all. Hey weirdos. I'm Alaina.

[Nicole Johnson (Homeland Security Special Agent)]

And I'm Ash, and we are the.

[Interviewer/Investigator]

Hosts of Morbid Podcast. Each week we dive into the dark and fascinating world of true crime, spooky history, and the unexplained. From infamous killers and unsolved mysteries to haunted places and strange legends, we cover it all with research, empathy, humor, and a few creative expletives. It's smart, it's spooky, and it's just the right amount of weird. Two new episodes drop every week, and there's even a bonus once a month. Find us wherever you listen to podcasts.

[Narrator/Reporter]

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[Narrator/Reporter]

Is comfortable with it. Take the HIV patient who received the Turkish biktarvy.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

As you can understand, receiving life saving medicine from a mysterious source in a language you can't read was quite concerning. They did not know if the product was safe, genuine, and so they reported it to their health care provider.

[Interviewer/Investigator]

And that's how it landed on your desk.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

That's right.

[Narrator/Reporter]

Gilead's testing determined that it was real biktarvy but intended to be sold in Turkey and not permitted to be shipped.

[Interviewer/Investigator]

To the U.S. so what's the real danger here?

[Narrator/Reporter]

It sounds like a lot of the.

[Interviewer/Investigator]

Drugs are just coming from another country. This is my choice.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

You don't know how that product was stored, handled or distributed. And it travels through an illegal supply chain that's easily infiltrated with counterfeits.

[Narrator/Reporter]

How did we get here, do you.

[Interviewer/Investigator]

Think, in terms of AFPS and this.

[Narrator/Reporter]

Need, it's really a need to save.

[Interviewer/Investigator]

Costs on sky high prescription medicines.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

Well, AFPs are another middleman, another for profit company that sits in between the pharmaceutical manufacturer and the patient. And in the US HIV medicines are fully covered. So you have to really ask yourself, why are they in this business? It has to be for profit. It's not for the patient.

[Narrator/Reporter]

They say that they are saving the patient money, they're saving the employer money.

[Interviewer/Investigator]

So they're saving everybody money on these prescriptions that cost a lot of money.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

They're promising savings, but they're delivering risk. And when it comes to prescription medicines, prioritizing cost over quality is dangerous.

[Narrator/Reporter]

Drugs like the Turkish biktarvy, she says, pose a critical threat to pharmaceutical companies like Gilead because they violate their intellectual property rights and undermine the safety and.

[Interviewer/Investigator]

Regulatory oversight of their drug supply chains.

[Narrator/Reporter]

Which is why Gilead filed a lawsuit last December to block the shipment of its medications from Overseas. Among the companies targeted is Maritane Health, part of Aetna, which is owned by CVS Health. Maritain contracted with a company that used an AFP called RX Valet, which is also a defendant, to supply high cost medication to insured patients.

[Greg Santuli (CEO of RX Valet)]

I've been in health care for a good 30 years, so most of my career.

[Narrator/Reporter]

Greg Santuli is a CEO of RX Valet and president of Advance Pharmacy, a mail order pharmacy that handles prescriptions in the U.S. he says Rx Valet sources high cost specialty medications from Canada, Australia and New Zealand and that it is legal and safe.

[Interviewer/Investigator]

Let's talk about the Gilead case if we can. The patient got Biktarvy that was mailed from a Turkish pharmacy. What happened there?

[Greg Santuli (CEO of RX Valet)]

So in some cases we do order some medications from some other countries like Turkey. They have a very sophisticated track and trace policy for medications which in some regards is as good, if not better than the United States.

[Interviewer/Investigator]

Is Turkey a tier one country?

[Greg Santuli (CEO of RX Valet)]

Turkey is not a tier one country, but it is a sophisticated country.

[Narrator/Reporter]

In fact, Turkey is one of the world's largest suppliers of counterfeit medicines, according to the office of the U.S. trade Representative.

[Interviewer/Investigator]

You've been in the health care industry for a long time, so you know that Turkey is well known for being an epicenter of counterfeit drugs. Isn't that a concern of yours?

[Greg Santuli (CEO of RX Valet)]

I mean, of course it's a concern. However, we have a very strong vetting process.

[Narrator/Reporter]

Affordable Rx Meds, whose label was on the Turkish Biktarvy, is a prescription referral service located in this nondescript Florida building which Santulli says he works with to obtain the medications from overseas. Affordable Rx Meds did not respond to.

[Interviewer/Investigator]

Our requests for comment. Have you read the FDA guidelines?

[Greg Santuli (CEO of RX Valet)]

Yes, I have.

[Interviewer/Investigator]

So then you'll know that that's what it says, that it's illegal to import drugs that are widely available in the United States States. It's actually legal to bring across drugs for a disease for which there is no effective treatment known in the United States.

[Greg Santuli (CEO of RX Valet)]

It actually does say for personal use. If you do bring, you can bring a drug into the United States for personal use as long as you have a prescription. No more than a 90 day supply physician's watching you for the disease state and the drug's been approved in the United States.

[Interviewer/Investigator]

It's in the documents the FDA tells us specifically. We asked specifically about this business model and they told us it is illegal to import drugs that are available and sold in the United States. Those are exactly the drugs that you import, correct?

[Greg Santuli (CEO of RX Valet)]

I have no comment.

[Interviewer/Investigator]

You still think that what you are doing is a public service, Is that right?

[Greg Santuli (CEO of RX Valet)]

100%. We do a public service. We help people get access to medications, people who would not be able to take medications.

[Narrator/Reporter]

He says his own parents had taken medications shipped from overseas for years with no problems.

[Interviewer/Investigator]

Are you putting patients lives at risk?

[Greg Santuli (CEO of RX Valet)]

If I was putting lives at risk, I put my own parents at risk. So no, we're not putting at risk. Unfortunately, sometimes there's bad actors out there and it does open up an opportunity for bad actors. However, there's a lot of good actors in this industry and my company is one of those.

[Interviewer/Investigator]

AFPs tell us that they are doing a public service that without them patients would not be able to receive the medicines they or their family needs because the choice is either use these medicines that they receive from the AFP or not get medicine at all because they would have to pay for it out of pocket and that's not affordable.

[Leigh Verbois (Former FDA Director)]

What I tell my friends and family is that the most expensive medicine that they could get is one that isn't safe, isn't effective or isn't high quality and doesn't meet the standards that are in FDA approved medicines. AFPs are not providing those measures to ensure that patients are getting safe, high quality and effective medicines.

[Narrator/Reporter]

Gilead also sued other companies connected to the biktarvy shipment. In June, a judge issued a preliminary injunction prohibiting the parties from importing Gilead medications. Maritane and the other defendants are appealing. Cvs, Maritane's parent company, told us it has long maintained a policy that it does not support programs for non FDA approved medications sourced from outside the United States and does not contract with companies to facilitate the importation of non FDA approved medications. It says it strongly disputes the allegations and is vigorously defending itself against the complaints. In late September, Gilead added Canorex, Electrx and Scripp Sourcing to its lawsuit and the court also ordered them to immediately stop sourcing Gilead medications from overseas while the case is pending. Canorex and Scripp Sourcing denied the allegations. Electrx declined to comment on the case. The Turkish pharmacy did not respond to our requests for comment. Santuli says without companies like Rx Valet, patients couldn't afford the medicine they or their families need.

[Greg Santuli (CEO of RX Valet)]

We help people get access to drugs and we work with a lot of people that are the backbone of America, like bartenders and servers through associations where they don't get access to really rich health benefits, where they get access to basic benefits and they don't have many medications on these plants.

[Narrator/Reporter]

But for organizations like the Cystic Fibrosis foundation, the price is too high. Mary Dwight is senior Vice president and.

[Interviewer/Investigator]

Chief Policy and Advocacy Officer. The biggest concern is the patient is the pawn here. The bottom line is that the person living with a chronic life threatening illness is being asked to jump through all these hoops just to make sure they have the treatments that they need. These alternative funding programs seem to advertise that they import these drugs. It's on their websites. They talk about it openly, but it's not legal. How can it be such an open secret? They're finding cracks and they're trying to expand the gaps. And we do need more transparency on what's happening and we need a lot more cracking down to make sure that people with CF or any other just have the gold standard protections and the high quality care and treatment that we know they deserve and they require.

[Narrator/Reporter]

The foundation is one of several non profits representing patients with severe diseases which have been warning for years about the dangers of these programs.

[Interviewer/Investigator]

Why are we making individuals with a life threatening disease, chronic illness, be the guinea pigs for something that we thus far have said is not the way we're going to go in US Healthcare? It's a broken system and we need to make sure everyone is paying attention.

[Lori Mayal (Gilead Sciences Anti-Counterfeiting)]

What are you doing in a meeting? That could have been an email.

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