Latest Drugwonks' Blog
It starts with a tweet:
@HHSGCMikeStuart -- Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. ("Hims") to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
Better late than never.
Last July in the Journal of the Academy of Public Health, I wrote, “The rise of large-scale compounding of GLP-1 drugs raises grave concerns. And those concerns are magnified by compounders’ disregard for the law … Failure to act risks eroding trust in our healthcare system generally. For decades, Americans have relied on the robust regulatory system in place to ensure that the medicines they take are safe and effective. If unscrupulous actors are allowed to continue putting patients at risk by exploiting regulatory lapses, it undermines trust in the whole system. The time to act is now.”
After pussyfooting around the unregulated manufacturing, brazen advertising, and aggressive nationwide distribution of illegal semaglutide products, the federal government has finally decided to act. It’s about time. Per FDA Commissioner Marty Makary, “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
This follows the gloves-off statement from Novo Nordisk, the manufacturer of Wegovy:
“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers' historic behaviour of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”
The timing is interesting. The unapproved, inauthentic, and untested knockoff semaglutide pill that HIMs and HERS intends to unlawfully market uses an untested delivery mechanism that lacks supporting evidence and has never been reviewed by FDA. While the FDA-approved Wegovy pill contains salcaprozate sodium (SNAC) technology to ensure absorption of semaglutide, HIMS and HERS claims their knockoff product uses liposomal technology that is intended to support absorption. It is entirely unknown whether this delivery mechanism is safe, what kinds of risks are presented by this absorption pathway, and whether it can effectively deliver the intended dose of semaglutide.
The FDA has expressly identified this technology as posing significant safety and efficacy risks to patients, and patients who take this compounded product are potentially at risk for over- or under-dosing as improper mixing of liposomes with active pharmaceutical ingredients (like semaglutide) could cause the compounded drug product to be potentially hazardous or ineffective.
As posted on Regulations.gov, Novo Nordisk has also carried out tests showing that samples of compounded oral liposomal semaglutide in suspension contained impurities as high as 41%. These findings have been reported to the FDA. These high levels of impurities further demonstrate the manufacturing and quality challenges of liposomal products and the significant safety risks for patients using them.
Science anyone?
Because of these safety and effectiveness concerns, the agency has issued a proposed rule to add liposome drug products to its list of products that may not be compounded due to, among other things, the complexity of their formulation, delivery mechanism, and release of the drug from the liposome.
And then:
Feb 7 (Reuters) - Online telehealth company Hims & Hers (HIMS.N), opens new tab on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the U.S. Food and Drug Administration said it would take action against it.
"Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said.
For the company that positioned itself as the poster child for affordable healthcare, it wasn’t a Profiles in Courage moment. But it does show they got the message.
We’ll see. This may not be the final death knell of the illegal, unsafe, and venal exploitation of the American public by semaglutide compounders, but it is certainly the beginning of the end. And the funeral can’t come soon enough.
“I did not attend the funeral, but I sent a nice letter saying I approved of it.”
– Mark Twain
@HHSGCMikeStuart -- Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. ("Hims") to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
Better late than never.
Last July in the Journal of the Academy of Public Health, I wrote, “The rise of large-scale compounding of GLP-1 drugs raises grave concerns. And those concerns are magnified by compounders’ disregard for the law … Failure to act risks eroding trust in our healthcare system generally. For decades, Americans have relied on the robust regulatory system in place to ensure that the medicines they take are safe and effective. If unscrupulous actors are allowed to continue putting patients at risk by exploiting regulatory lapses, it undermines trust in the whole system. The time to act is now.”
After pussyfooting around the unregulated manufacturing, brazen advertising, and aggressive nationwide distribution of illegal semaglutide products, the federal government has finally decided to act. It’s about time. Per FDA Commissioner Marty Makary, “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
This follows the gloves-off statement from Novo Nordisk, the manufacturer of Wegovy:
“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers' historic behaviour of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”
The timing is interesting. The unapproved, inauthentic, and untested knockoff semaglutide pill that HIMs and HERS intends to unlawfully market uses an untested delivery mechanism that lacks supporting evidence and has never been reviewed by FDA. While the FDA-approved Wegovy pill contains salcaprozate sodium (SNAC) technology to ensure absorption of semaglutide, HIMS and HERS claims their knockoff product uses liposomal technology that is intended to support absorption. It is entirely unknown whether this delivery mechanism is safe, what kinds of risks are presented by this absorption pathway, and whether it can effectively deliver the intended dose of semaglutide.
The FDA has expressly identified this technology as posing significant safety and efficacy risks to patients, and patients who take this compounded product are potentially at risk for over- or under-dosing as improper mixing of liposomes with active pharmaceutical ingredients (like semaglutide) could cause the compounded drug product to be potentially hazardous or ineffective.
As posted on Regulations.gov, Novo Nordisk has also carried out tests showing that samples of compounded oral liposomal semaglutide in suspension contained impurities as high as 41%. These findings have been reported to the FDA. These high levels of impurities further demonstrate the manufacturing and quality challenges of liposomal products and the significant safety risks for patients using them.
Science anyone?
Because of these safety and effectiveness concerns, the agency has issued a proposed rule to add liposome drug products to its list of products that may not be compounded due to, among other things, the complexity of their formulation, delivery mechanism, and release of the drug from the liposome.
And then:
Feb 7 (Reuters) - Online telehealth company Hims & Hers (HIMS.N), opens new tab on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the U.S. Food and Drug Administration said it would take action against it.
"Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said.
For the company that positioned itself as the poster child for affordable healthcare, it wasn’t a Profiles in Courage moment. But it does show they got the message.
We’ll see. This may not be the final death knell of the illegal, unsafe, and venal exploitation of the American public by semaglutide compounders, but it is certainly the beginning of the end. And the funeral can’t come soon enough.
“I did not attend the funeral, but I sent a nice letter saying I approved of it.”
– Mark Twain
If you’re still being told that compounded GLP-1 risks are “overblown,” read the FDA’s latest warning letter.
Last summer, CMPI warned that some large-scale compounders were drifting far from traditional pharmacy practice — importing questionable, if not illegal, foreign ingredients and marketing unapproved GLP-1s at industrial scale.
FDA recently backed up that concern.
It issued a warning letter to Darmerica, LLC — a large API importer supplying compounders — for importing adulterated ingredients from unregistered or FDA-alerted facilities, mislabeling shipments to bypass customs scrutiny, stripping original labels that concealed product origin and grade, and ignoring pharmacy reports of visible contamination in its APIs.
Multiple GLP-1s were involved, including retatrutide and cagrilintide, which are investigational molecules not approved by FDA and indisputably not eligible for lawful compounding.
You can’t build a safe medicine on an illicit or unverified ingredient. When suppliers like Darmerica fail to properly qualify a foreign source, or pass-off illicit API as the real Macoy, they harm both the compounder with whom they transact and the patients who receive the substandard compounded drugs.
This isn’t about legitimate, patient-specific compounding. It’s about commercial scale production without safety standards — and the erosion of guardrails that protect patients. If compounding is to remain a trusted practice, it must stay within clear lines.
Warning letters like this show why stronger oversight is seriously needed. Common sense reforms like those suggested in the SAFE Drugs Act merit immediate attention.
No one should be deceived into believing they’re taking genuine American medicine when they’re really getting an illicit foreign knockoff. Patients deserve medicines made transparently and held to consistent standards.
Anything less is a public health risk.
In a RealClearHealth paper published this week, Prior Authorization: AHIP’s Commitments, Paragon Health Institute's Jackson Hammond explores recent actions taken by America’s Health Insurance Plans (AHIP) in partnership with the Trump Administration to look at reforms to when and how individuals are subjected to an insurance tool called prior authorization. First announced in July of 2025, AHIP has specifically made commitments to “streamline, simplify and reduce prior authorization,” and the paper builds out a solid framework for insurers as they consider where best to focus their efforts.
it makes sense for AHIP to commit to exploring improvements to how, when, and why prior authorization policies are used – not only for medical claims as laid out in their commitment statement but also for pharmaceutical claims, which is of interest to CMS and the Administration.
In short, the science underpinning new treatments, the economic impact of inefficient care, and the substantial population of Americans who are suffering from migraine without the ability to properly treat it, all point toward migraine as an area where reduced reliance on stringent prior authorization mechanisms would be a win for all involved.
Let's get serious.
it makes sense for AHIP to commit to exploring improvements to how, when, and why prior authorization policies are used – not only for medical claims as laid out in their commitment statement but also for pharmaceutical claims, which is of interest to CMS and the Administration.
In short, the science underpinning new treatments, the economic impact of inefficient care, and the substantial population of Americans who are suffering from migraine without the ability to properly treat it, all point toward migraine as an area where reduced reliance on stringent prior authorization mechanisms would be a win for all involved.
Let's get serious.
Following an FDA inspection, ProRx, a 503B outsourcing facility based in Exton, Pennsylvania, had its second major recall of compounded semaglutide and tirzepatide products.
The recall covers nearly 40,000 vials of compounded semaglutide and tirzepatide due to a “lack of assurance of sterility.” This is on top of a recall last year of over 15,000 vials of compounded semaglutide and tirzepatide for the same reason. That’s tens of thousands of doses of potentially unsafe, non-sterile injectables that made their way into the market – all produced outside FDA-approved manufacturing channels.
As I’ve previously explained, it is unlawful for 503B facilities to compound any semaglutide or tirzepatide products. Yet that’s exactly what’s happening – at scale – and, as the recall underscores, without “assurance of sterility.” But that’s not all that ProRx has been cited for. Earlier this year, FDA sent a warning letter to ProRx for failing to wear gloves, using “non-sterile wipes” in aseptic processing areas, and allowing a “flying insect” into an area used for sterile compounding. This recall is yet another proof point that we cannot continue to allow unlawful compounders to operate unchecked. FDA needs to step up and act now.
The recall covers nearly 40,000 vials of compounded semaglutide and tirzepatide due to a “lack of assurance of sterility.” This is on top of a recall last year of over 15,000 vials of compounded semaglutide and tirzepatide for the same reason. That’s tens of thousands of doses of potentially unsafe, non-sterile injectables that made their way into the market – all produced outside FDA-approved manufacturing channels.
As I’ve previously explained, it is unlawful for 503B facilities to compound any semaglutide or tirzepatide products. Yet that’s exactly what’s happening – at scale – and, as the recall underscores, without “assurance of sterility.” But that’s not all that ProRx has been cited for. Earlier this year, FDA sent a warning letter to ProRx for failing to wear gloves, using “non-sterile wipes” in aseptic processing areas, and allowing a “flying insect” into an area used for sterile compounding. This recall is yet another proof point that we cannot continue to allow unlawful compounders to operate unchecked. FDA needs to step up and act now.
FDA Must Stop Online Compounders Before Patients Get Hurt
Online pharmacies are exploiting patients with knock-off GLP-1 drugs that are untested, unsafe, and illegal. These compounded products are being marketed as containing the “same active ingredient as Ozempic or Wegovy” or as including “clinically proven ingredients”—claims that are outright false. Yet, patients are being misled into believing these drugs are safe and effective.
A January 2025 study found that many websites selling compounded GLP-1s fail to disclose that these products are not FDA-approved, with some even falsely labeling them as “generics.” Many of these drugs are made from active pharmaceutical ingredients sourced from illegal foreign suppliers—primarily in China—posing a serious, avoidable threat to patient safety.
The FDA’s recent warning letters are a step in the right direction, but they barely scratch the surface. Mass compounding of GLP-1s is out of control, and patients are paying the price while mass compounders profit. The FDA already has the authority to act and must follow through with aggressive enforcement: requiring compounders that operate like manufacturers to register as such, cracking down on telehealth schemes disguised as “personalization,” and penalizing repeat offenders.
Patients deserve to know that when the FDA acts, it acts decisively. Until enforcement is consistent and visible, unscrupulous compounders will continue exploiting regulatory weaknesses, putting profits ahead of patient safety, and endangering lives.
For more on the threat compounded GLP-1s pose to patient safety, see CMPI’s report.
Online pharmacies are exploiting patients with knock-off GLP-1 drugs that are untested, unsafe, and illegal. These compounded products are being marketed as containing the “same active ingredient as Ozempic or Wegovy” or as including “clinically proven ingredients”—claims that are outright false. Yet, patients are being misled into believing these drugs are safe and effective.
A January 2025 study found that many websites selling compounded GLP-1s fail to disclose that these products are not FDA-approved, with some even falsely labeling them as “generics.” Many of these drugs are made from active pharmaceutical ingredients sourced from illegal foreign suppliers—primarily in China—posing a serious, avoidable threat to patient safety.
The FDA’s recent warning letters are a step in the right direction, but they barely scratch the surface. Mass compounding of GLP-1s is out of control, and patients are paying the price while mass compounders profit. The FDA already has the authority to act and must follow through with aggressive enforcement: requiring compounders that operate like manufacturers to register as such, cracking down on telehealth schemes disguised as “personalization,” and penalizing repeat offenders.
Patients deserve to know that when the FDA acts, it acts decisively. Until enforcement is consistent and visible, unscrupulous compounders will continue exploiting regulatory weaknesses, putting profits ahead of patient safety, and endangering lives.
For more on the threat compounded GLP-1s pose to patient safety, see CMPI’s report.
Unfriendly foreign nations are holding America’s medicine cabinets for ransom. Right now, there is the very real risk of drug shortages being caused, on purpose, by foreign governments for political goals that put American patients at risk.
Why is this happening? What can we do about it? Who is in charge?
Our national supply chain for essential medicines, for both domestic use and for our soldiers in the field, is a global one. One key problem is that we have allowed countries, not always friendly to our own national interests, to have their fingers on the buttons that controls the flow of pharmaceuticals and medical devices (both finished products and Active Pharmaceutical Ingredients (API) to our shores.
According to the FDA, “We don’t know whether Chinese facilities are actually producing APIs, how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the United States. Similarly, we do not have information that would enable us to assess the resilience of the U.S. manufacturing base, should it be tested by China’s withdrawal from supplying the U.S. market.”
We are allowing patient safety to take second place to supply chain savings. And we are playing Russian Roulette with often unsavory Chinese partners and their political masters. Why have we allowed this to happen? That answer is simple – follow the money.
In nations such as the People’s Republic of China, labor is cheap, quality standards are often low, and FDA oversight is both thin and limited. Thin because of the absurdly small number of in-country FDA inspectors and limited because of the restraints placed on those inspectors by Beijing to undertake and accomplish such basic tasks as surprise inspections.
When you are required to tell them you’re coming, manufacturing logs get altered, factory floors get cleaned, expired supplies get moved, and access to many key areas get restricted. This is a recipe for disaster.
We have not learned from the lessons of Covid-19. During the pandemic, we suffered an acute shortage of contrast agent -- the substance used in medical imaging to enhance the visibility of organs, blood vessels, and tissues, making them appear clearer on X-rays, CT scans, and MRIs.
In 2022, a large contrast agent manufacturing facility outside of Shanghai shut down during a pandemic lockdown. Here at home, this resulted in radical decreases in angiograms, perfusion scans, and other tests crucial for stroke assessments, cancer diagnoses, and other urgent medical care. This one plant in China provides almost all the contrast agent used in the United States. And that was because of Covid-19. It’s not hard to imagine similar supply chain crises for diabetes test strips or ADHD medications, or penicillin driven by geopolitical purposes. It’s not hard to imagine – because shortages of these products are already happening due to our lack of interest and oversight.
And that’s not even mentioning the deaths that have occurred because of inappropriate quality oversight. In 2008, substandard heparin from China (an anticoagulant used to decrease blood clotting), killed 81 people, and left 785 severely injured -- in the United States. These are supply chain deaths.
What can we do about it? We need to strengthen our national supply chain for essential medical products by giving the FDA the authorities it needs to more closely monitor materials sourcing and manufacturing and to advance both on-shoring and friend-shoring manufacturing strategies.
We must extricate our medical supply chain from countries that could weaponize this dependence, by manufacturing on our own shores when practical and shifting our foreign partnerships from places like China to more friendly nations such as those of the Abraham Accords. That’s called “Friend-Shoring.”
In fact, there is pending that instructs the FDA to open an Abraham Accords office for precisely this purpose. It’s a good idea.
Any proper risk-benefit analysis of this friend-shoring initiative shows a highly positive outcome for both the nations of the Abraham Accords and the United States. For the members of the Abraham Accords, it represents an opportunity to grow their biopharmaceutical sectors and for the U.S. it means a strengthened supply chain forged with stronger fraternal links — all within a framework that prioritizes quality, patient safety, and cost-savings -- in that order.
As President Eisenhower said, “In the final choice a soldier's pack is not so heavy as a prisoner's chains.”
Why is this happening? What can we do about it? Who is in charge?
Our national supply chain for essential medicines, for both domestic use and for our soldiers in the field, is a global one. One key problem is that we have allowed countries, not always friendly to our own national interests, to have their fingers on the buttons that controls the flow of pharmaceuticals and medical devices (both finished products and Active Pharmaceutical Ingredients (API) to our shores.
According to the FDA, “We don’t know whether Chinese facilities are actually producing APIs, how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the United States. Similarly, we do not have information that would enable us to assess the resilience of the U.S. manufacturing base, should it be tested by China’s withdrawal from supplying the U.S. market.”
We are allowing patient safety to take second place to supply chain savings. And we are playing Russian Roulette with often unsavory Chinese partners and their political masters. Why have we allowed this to happen? That answer is simple – follow the money.
In nations such as the People’s Republic of China, labor is cheap, quality standards are often low, and FDA oversight is both thin and limited. Thin because of the absurdly small number of in-country FDA inspectors and limited because of the restraints placed on those inspectors by Beijing to undertake and accomplish such basic tasks as surprise inspections.
When you are required to tell them you’re coming, manufacturing logs get altered, factory floors get cleaned, expired supplies get moved, and access to many key areas get restricted. This is a recipe for disaster.
We have not learned from the lessons of Covid-19. During the pandemic, we suffered an acute shortage of contrast agent -- the substance used in medical imaging to enhance the visibility of organs, blood vessels, and tissues, making them appear clearer on X-rays, CT scans, and MRIs.
In 2022, a large contrast agent manufacturing facility outside of Shanghai shut down during a pandemic lockdown. Here at home, this resulted in radical decreases in angiograms, perfusion scans, and other tests crucial for stroke assessments, cancer diagnoses, and other urgent medical care. This one plant in China provides almost all the contrast agent used in the United States. And that was because of Covid-19. It’s not hard to imagine similar supply chain crises for diabetes test strips or ADHD medications, or penicillin driven by geopolitical purposes. It’s not hard to imagine – because shortages of these products are already happening due to our lack of interest and oversight.
And that’s not even mentioning the deaths that have occurred because of inappropriate quality oversight. In 2008, substandard heparin from China (an anticoagulant used to decrease blood clotting), killed 81 people, and left 785 severely injured -- in the United States. These are supply chain deaths.
What can we do about it? We need to strengthen our national supply chain for essential medical products by giving the FDA the authorities it needs to more closely monitor materials sourcing and manufacturing and to advance both on-shoring and friend-shoring manufacturing strategies.
We must extricate our medical supply chain from countries that could weaponize this dependence, by manufacturing on our own shores when practical and shifting our foreign partnerships from places like China to more friendly nations such as those of the Abraham Accords. That’s called “Friend-Shoring.”
In fact, there is pending that instructs the FDA to open an Abraham Accords office for precisely this purpose. It’s a good idea.
Any proper risk-benefit analysis of this friend-shoring initiative shows a highly positive outcome for both the nations of the Abraham Accords and the United States. For the members of the Abraham Accords, it represents an opportunity to grow their biopharmaceutical sectors and for the U.S. it means a strengthened supply chain forged with stronger fraternal links — all within a framework that prioritizes quality, patient safety, and cost-savings -- in that order.
As President Eisenhower said, “In the final choice a soldier's pack is not so heavy as a prisoner's chains.”
Months after the FDA’s deadline for the manufacture and sale of compounded versions has passed, large-scale corporate compounders continue flooding the market with unapproved products. These are not your local pharmacists making a pediatric formulation or dye-free alternative. They are unregulated pharmaceutical companies flagrantly skirting rules and violating federal laws.
Left unaddressed, the mass production and misleading marketing of compounded GLP-1s will result in a public health disaster. FDA has already received dozens of adverse event reports tied to compounded GLP-1s — including hospitalizations, overdoses, and severe reactions — but the real number is likely far higher due to underreporting. When compounders mass produce and market without proper oversight, patient medical histories go unchecked, potential drug interactions are missed, and adverse events are underreported. This is not about access – it’s exploitation, pure and simple.
Our latest report lays out the problem in stark terms and offers a path forward grounded in existing law, sound policy, and patient safety imperatives. What we’re seeing today is a failure of enforcement, not a failure of policy.
The FDA doesn’t need new powers; it needs to enforce the ones it has. That means calling out bad actors, coordinating with states to shut down illegal operations, and ensuring compounded drugs are only used when there is a demonstrated medical need. Every day we delay, more patients are put at risk – and if we wait for a tragedy to act, the cost will be measured in lives.
People with Obesity are getting the shaft from the FDA. That’s got to change.
It is likely to come as a surprise that, considering all the attention and headlines about the America’s obesity epidemic and GLP-1 drugs such as Ozempic, Zepbound, and Mounjaro, that the FDA does not routinely update drug labels with safety information for people with obesity. The agency that Nobel Prize winner Milton Friedman once accused as being “obsessed with safety” doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large scale clinical trials regularly and purposely exclude them -- per clinical trial designs approved by the FDA.
Such scientific omission is irrational, unscientific, not in the best interests of patients, contrary to the wishes of the medical profession – and just plain wrong.
Consider the evidence:
Per a 2024 study in Clinical Pharmacokinetics, "Optimal clinical decision making in patients with obesity is impossible without prior study of drug of interest in this population."
The FDA has some explaining to do. The big unanswered question is why neither drug developers nor the FDA have acted on this recognized and solvable public health blind spot.
The FDA’s newly minted Commissioner, Dr. Martin Makary, needs to ask his staff two very direct questions::
Why does the agency require labels to include hepatic impairment pharmacokinetic information, but not information for patients with obesity -- since the population of people with hepatic impairments is a twentieth the size of people with obesity.
According to Harvard researchers, serious gaps exist in what is known about the effects of obesity on drug disposition and current label information on drug use. Why it acceptable for these gaps continue to exist within the universe of FDA-approved medicines and, more importantly, why do they continue to exist unexamined and uncorrected?
The Commissioner should ask his staff for a list of drugs whose labels have been updated to reflect the pharmacokinetics of people with obesity and ask for an explanation as to why the drugs referenced in the Harvard study are not amongst them.
Obesity is not a rare or orphan disease. But that shouldn’t mean the agency can ignore a condition that impacts nearly 100 million adult Americans. It is both shocking and disappointing that the FDA hasn’t acted with more urgency to proactively remediate drug labels so that physicians can be aware of both the problem and the solution. What makes matter worse it that it’s an easy regulatory fix. The FDA must put equal weight behind what happens post-approval, as it does in addressing the much more controlled premarket clinical trial environment. This also raises important questions relative to the current strengths and weaknesses of the agency’s post-market surveillance programs. Dr. Makary should insist that the agency he now leads augment transparency and clarity through more clear and comprehensive labeling updates.
Now is the time to rectify this serious oversight, prove to Health and Human Services Secretary Robert F. Kennedy, Jr. that the agency isn’t an industry “sock puppet,” and help advance the health of a population that represents 40% of the United States population. To continue to ignore this problem is regulatory malpractice of the first order.
It is likely to come as a surprise that, considering all the attention and headlines about the America’s obesity epidemic and GLP-1 drugs such as Ozempic, Zepbound, and Mounjaro, that the FDA does not routinely update drug labels with safety information for people with obesity. The agency that Nobel Prize winner Milton Friedman once accused as being “obsessed with safety” doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large scale clinical trials regularly and purposely exclude them -- per clinical trial designs approved by the FDA.
Such scientific omission is irrational, unscientific, not in the best interests of patients, contrary to the wishes of the medical profession – and just plain wrong.
Consider the evidence:
Per a 2024 study in Clinical Pharmacokinetics, "Optimal clinical decision making in patients with obesity is impossible without prior study of drug of interest in this population."
The FDA has some explaining to do. The big unanswered question is why neither drug developers nor the FDA have acted on this recognized and solvable public health blind spot.
The FDA’s newly minted Commissioner, Dr. Martin Makary, needs to ask his staff two very direct questions::
Why does the agency require labels to include hepatic impairment pharmacokinetic information, but not information for patients with obesity -- since the population of people with hepatic impairments is a twentieth the size of people with obesity.
According to Harvard researchers, serious gaps exist in what is known about the effects of obesity on drug disposition and current label information on drug use. Why it acceptable for these gaps continue to exist within the universe of FDA-approved medicines and, more importantly, why do they continue to exist unexamined and uncorrected?
The Commissioner should ask his staff for a list of drugs whose labels have been updated to reflect the pharmacokinetics of people with obesity and ask for an explanation as to why the drugs referenced in the Harvard study are not amongst them.
Obesity is not a rare or orphan disease. But that shouldn’t mean the agency can ignore a condition that impacts nearly 100 million adult Americans. It is both shocking and disappointing that the FDA hasn’t acted with more urgency to proactively remediate drug labels so that physicians can be aware of both the problem and the solution. What makes matter worse it that it’s an easy regulatory fix. The FDA must put equal weight behind what happens post-approval, as it does in addressing the much more controlled premarket clinical trial environment. This also raises important questions relative to the current strengths and weaknesses of the agency’s post-market surveillance programs. Dr. Makary should insist that the agency he now leads augment transparency and clarity through more clear and comprehensive labeling updates.
Now is the time to rectify this serious oversight, prove to Health and Human Services Secretary Robert F. Kennedy, Jr. that the agency isn’t an industry “sock puppet,” and help advance the health of a population that represents 40% of the United States population. To continue to ignore this problem is regulatory malpractice of the first order.
When it comes to Robert F. Kennedy, Jr., I refuse to yell. I refuse to name-call. I refuse to sign FaceBook petitions with cut-and-paste social media tirades. I refuse to predict the end of the world – because I want to make a positive difference. I want my voice to be heard by those in positions of authority and influence. I’ve been around the block enough times to recognize that requires being persistent, patient, persuasive, polite, respectful, and humble. I refuse to reflexively kowtow to my betters. I refuse to be a sock-puppet for science. This doesn’t make me an “enabler.” It makes me a realist.
The mainstream, well-meaning, and devoted public health community has, in very short order, effectively zeroed out any influence they might have had with the new administration by making their attacks judgmental and personal and the media has been all to glad to magnify these lapses in rhetorical judgment. Two words – stop it.
Here’s my message to those who believe they have somehow earned the right to peer down their peer-reviewed noses and at those with fewer letters after their names – get over yourselves. You’re on the outside looking in and your Nobels ring no bells with RFK2. As another Kennedy once said, “Life is unfair.” This is your wake-up call.
I’m not a science-denier. It’s not what “the experts” are saying that’s wrong (although sometimes it is). It’s the way they’re saying it. It’s as useless as trying make a non-English speaker understand you by TALKING LOUDER – and a whole lot more dangerous. Exaggeration is the enemy of belief and trust – and its bad science. Exaggeration is misinformation by another name.
Not everything the new RFK2 crew are doing represents an end to civilization as we know it. The daily hand wringing and predictions of doom-and-gloom by professors and pundits show how little they have learned from the pandemic experience. “It’s settled science, so shut up,” didn’t work during the dark days of Covid-19 – and we continue to reap the whirlwind. Ringing the alarm bells all day every day just makes for annoying ambient noise that becomes increasingly easy to ignore.
It’s time for less atonal cowbell and more determined, cool and collected engagement.
Turning up the volume on pomposity is the height of self-importance and only serves to turn real experts into late-night punchlines. It’s time for America’s public health establishment to get out from behind the sheltered protection of the lectern, and onto a more collegial playing field.
What? Engagement with that bunch of yahoos? Well, first of all, that’s rude – and secondly, that’s right. You may have tenure, but that doesn’t give you much if any policy heft in the world of realpolitik. Otto von Bismarck reminds us, “Politics is the art of the possible.” There’s no ivy on the walls of HHS headquarters. Sometimes you have to eat some crow if you want a seat at the table. Don’t believe me? Ask Volodymyr Zelenskyy.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
The mainstream, well-meaning, and devoted public health community has, in very short order, effectively zeroed out any influence they might have had with the new administration by making their attacks judgmental and personal and the media has been all to glad to magnify these lapses in rhetorical judgment. Two words – stop it.
Here’s my message to those who believe they have somehow earned the right to peer down their peer-reviewed noses and at those with fewer letters after their names – get over yourselves. You’re on the outside looking in and your Nobels ring no bells with RFK2. As another Kennedy once said, “Life is unfair.” This is your wake-up call.
I’m not a science-denier. It’s not what “the experts” are saying that’s wrong (although sometimes it is). It’s the way they’re saying it. It’s as useless as trying make a non-English speaker understand you by TALKING LOUDER – and a whole lot more dangerous. Exaggeration is the enemy of belief and trust – and its bad science. Exaggeration is misinformation by another name.
Not everything the new RFK2 crew are doing represents an end to civilization as we know it. The daily hand wringing and predictions of doom-and-gloom by professors and pundits show how little they have learned from the pandemic experience. “It’s settled science, so shut up,” didn’t work during the dark days of Covid-19 – and we continue to reap the whirlwind. Ringing the alarm bells all day every day just makes for annoying ambient noise that becomes increasingly easy to ignore.
It’s time for less atonal cowbell and more determined, cool and collected engagement.
Turning up the volume on pomposity is the height of self-importance and only serves to turn real experts into late-night punchlines. It’s time for America’s public health establishment to get out from behind the sheltered protection of the lectern, and onto a more collegial playing field.
What? Engagement with that bunch of yahoos? Well, first of all, that’s rude – and secondly, that’s right. You may have tenure, but that doesn’t give you much if any policy heft in the world of realpolitik. Otto von Bismarck reminds us, “Politics is the art of the possible.” There’s no ivy on the walls of HHS headquarters. Sometimes you have to eat some crow if you want a seat at the table. Don’t believe me? Ask Volodymyr Zelenskyy.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
When speaking this past week at the White House, Oracle founder Larry Ellison said that the newly announced ‘Stargate’ – an artificial intelligence infrastructure project – will pave the way to the United States developing a ‘cancer vaccine.” Well, as my grandmother used to say, “From his mouth to God’s ears.”
In the past, such advances have led our country to longer, healthier lives, to save premature babies, and irradicate devastating diseases. Innovators should be rewarded for propelling the future of care and treatment options for the millions of Americans. Instead, the unfortunate reality is that innovators now stand to be punished due to outdated policies governing Medicare administered by third party middlemen with financial incentive to deny access to innovative diagnostic testing.
Crucially, finding a way to eradicate cancers, one of our planet’s most devastating diseases, will be in vain without advancements in diagnostic testing. However, this comes with an urgent caveat -- this future will not be fulfilled if healthcare middlemen continue to have their way.
The 68 million Americans covered by Medicare (including me) have their claims processed by private insurers known as Medicare Administrative Contractors (MACs). Last month, two of those MACs – Novitas Solutions and First Coast Service Options (FCSO) – issued a Local Coverage Determination (LCD) which ended the coverage of nine groundbreaking cancer diagnostic tests. It’s a warning shot across the bow to precision medicine and investment in innovation.
These decisions must not stand. Early detection is a critical step of prevention, especially for cancer patients. Tests like these allow doctors to intervene and understand their patients’ care far earlier into their diagnosis, enabling them to develop more personalized and cost-efficient treatment plans that, most importantly, improve outcomes. When such care is delayed or inaccessible, there are often greater problems associated with treatment, such as more intensive intervention options like biopsies or radiation therapy or potentially missed and undertreated disease. This comes alongside higher costs of care and, unsettlingly, a lower chance of survival.
There also must be high alert for “regulatory mission creep.” That’s why the 21st Century Cures Act included additional guidelines on the MACs’ LCD process and determination timeline. MACs delaying their decision and blatantly diverting from the Cures Act is a flagrant breaking of the law that has become the norm for MACs – not an exception – and certainly not an exemption.
Cancer patients are not the only ones negatively impacted by these actions. In 2023, the MAC Palmetto GBA, published an article to the CMS website, changing the coverage of two tests for organ transplant patients --one of which could predict rejection problems with transplanted organs weeks or even months ahead of clinical signs of damage.
Luckily, CMS stepped in and coverage for the blood tests was restored. That was not without struggle and hardships for patients and their loved ones. In the process, it also came to light that the MAC ignored the recommendations of medical experts when making the decision to deny coverage.
The bad news is that CMS is limiting access to cutting-edge diagnostics for those on Medicare. This negligence is unacceptable. It is regulatory malpractice. CMS and MACs must be held accountable and reduce uncertainty for patients, healthcare providers, and innovators alike instead of allowing critical coverage decisions to cause greater uncertainty in the future of American healthcare. Additional Congressional oversight should push CMS and their MAC henchmen to reexamine their coverage decisions that impact seniors’ access to novel healthcare and increase taxpayer burden.
If we are to more fully and rapidly realize a world where we can detect cancer, organ failure, and a host of diseases before they occur, we must establish the foundations and incentives to develop testing and treatments. This is the goal of Mr. Ellison’s Stargate initiative – and it is one worth pursuing aggressively.
Peter J. Pitts is president and co-founder of the Center for Medicine in the Public Interest and a former associate commissioner of the U.S. Food and Drug Administration.
In the past, such advances have led our country to longer, healthier lives, to save premature babies, and irradicate devastating diseases. Innovators should be rewarded for propelling the future of care and treatment options for the millions of Americans. Instead, the unfortunate reality is that innovators now stand to be punished due to outdated policies governing Medicare administered by third party middlemen with financial incentive to deny access to innovative diagnostic testing.
Crucially, finding a way to eradicate cancers, one of our planet’s most devastating diseases, will be in vain without advancements in diagnostic testing. However, this comes with an urgent caveat -- this future will not be fulfilled if healthcare middlemen continue to have their way.
The 68 million Americans covered by Medicare (including me) have their claims processed by private insurers known as Medicare Administrative Contractors (MACs). Last month, two of those MACs – Novitas Solutions and First Coast Service Options (FCSO) – issued a Local Coverage Determination (LCD) which ended the coverage of nine groundbreaking cancer diagnostic tests. It’s a warning shot across the bow to precision medicine and investment in innovation.
These decisions must not stand. Early detection is a critical step of prevention, especially for cancer patients. Tests like these allow doctors to intervene and understand their patients’ care far earlier into their diagnosis, enabling them to develop more personalized and cost-efficient treatment plans that, most importantly, improve outcomes. When such care is delayed or inaccessible, there are often greater problems associated with treatment, such as more intensive intervention options like biopsies or radiation therapy or potentially missed and undertreated disease. This comes alongside higher costs of care and, unsettlingly, a lower chance of survival.
There also must be high alert for “regulatory mission creep.” That’s why the 21st Century Cures Act included additional guidelines on the MACs’ LCD process and determination timeline. MACs delaying their decision and blatantly diverting from the Cures Act is a flagrant breaking of the law that has become the norm for MACs – not an exception – and certainly not an exemption.
Cancer patients are not the only ones negatively impacted by these actions. In 2023, the MAC Palmetto GBA, published an article to the CMS website, changing the coverage of two tests for organ transplant patients --one of which could predict rejection problems with transplanted organs weeks or even months ahead of clinical signs of damage.
Luckily, CMS stepped in and coverage for the blood tests was restored. That was not without struggle and hardships for patients and their loved ones. In the process, it also came to light that the MAC ignored the recommendations of medical experts when making the decision to deny coverage.
The bad news is that CMS is limiting access to cutting-edge diagnostics for those on Medicare. This negligence is unacceptable. It is regulatory malpractice. CMS and MACs must be held accountable and reduce uncertainty for patients, healthcare providers, and innovators alike instead of allowing critical coverage decisions to cause greater uncertainty in the future of American healthcare. Additional Congressional oversight should push CMS and their MAC henchmen to reexamine their coverage decisions that impact seniors’ access to novel healthcare and increase taxpayer burden.
If we are to more fully and rapidly realize a world where we can detect cancer, organ failure, and a host of diseases before they occur, we must establish the foundations and incentives to develop testing and treatments. This is the goal of Mr. Ellison’s Stargate initiative – and it is one worth pursuing aggressively.
Peter J. Pitts is president and co-founder of the Center for Medicine in the Public Interest and a former associate commissioner of the U.S. Food and Drug Administration.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
