Dr. Rich Roberts: I asked my Rav if I may publish this. He told me that I am required, by the Torah, to publish this as widely as possible immediately and to follow it with additional publications.

On June 17, 2026, Ami Living magazine’s cover story was a highly false article about dangers of generic drugs. I have had extensive messaging with Ami Living about the falsehoods and wrote a retort for Ami Living to publish. I toned down my article per the request of Ami Living. However, the only retort that they agreed to publish was a very neutered version of my already muted article. I am providing the following to protect the frum community from unnecessary concern, cost, and potential unavailability of medication.

Please know that brand and generic manufacturers are required to fulfill the same FDA safety standards. FDA has deemed it illegal for a branded drug company to claim that their products are better than an FDA approved generic because they are both held to the SAME FDA quality standards.

First, I will list for you some of the false information in the Ami Living cover story. Then I will provide you with the article that I wrote for them. Lastly, I provide for you my credentials.

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False information in the Ami Living cover story

1. The first eleven paragraphs of the Ami Living article told a heart-wrenching story about a girl with a lung transplant who died because her tacrolimus was changed from the brand to a generic. Ami Living wrote that the generic tacrolimus “…provided only half of the oxygen level she needed to survive”. But here are some problems with that statement.
   1. Tacrolimus does not provide oxygen. It does not carry oxygen. It affects the immune system to prevent transplanted organ rejection.
   2. Patient blood levels of tacrolimus are measured frequently in organ transplant patients to detect and correct low blood levels before damage is done to the patient. If the tacrolimus levels were allowed to stay below therapeutic levels then that is a problem with the medical team.
   3. The Indian generic did have a recall of tacrolimus since some half-strength capsules were mixed in bottles with full-strength capsules. But the brand company’s tacrolimus also had a recall with some capsules having NO tacrolimus at all. So it is illegitimate to condemn generics when the brand had an even worse problem.
2. The article claims that Indian generics have “…unleashed a slew of deaths…” globally.
   1. No proof is given. It’s just a slanderous claim.
   2. For Americans, the drugs that come into the US go through the FDA approval process and ongoing FDA inspections. What happens in Asia and Africa does not pertain to drugs made for the US.
   3. Don’t cases of “…a slew of deaths…” make the front pages of major news outlets as crises like an Ebola outbreak do or a mass poisoning would? How many deaths are “a slew”? How many lives were saved by these very poor countries getting drugs, even if a lower quality than the US, versus no drugs at all? Btw, I know that unregulated Asian drug manufacturers do send lower quality drugs to Asia and Africa versus the US. It’s a shame but how does that inform frum people, in the US, that they are at risk taking the FDA approved versions from FDA inspected manufacturing plants and therefore must buy much higher priced brand versions?
3. Ami Living writes that “…thousands of grievous medical conditions…are attributed to poor quality control…In one case, a cancer patient was given…” the wrong drug.
   1. No proof is given of these “thousands of grievous medical conditions”. It’s just slander.
   2. There are 300,000,000,000 generic tablets used in the US each year (Yes, 300 billion). Even if true, is one cited case sufficient to scare frum people into spending much more on the brand version of the drug? Mistakes in drug manufacturing do happen but they happen for brand and generic drugs.
4. Ami Living writes that “…the FDA…practically colludes with the companies that make (generic drugs)”. Wrong.
   1. I battled against FDA for 24 years. FDA is constantly trying to find the slightest excursions at drug companies and reporting them in extremely exaggerated fashion. I even documented FDA committing multiple frauds against our company in an attempt to shut us down (but that’s a story for another time). FDA does not “collude” with drug companies. FDA inspectors are motivated to find and write violations.
   2. For example, say that 10 tablets are checked for hardness every half hour throughout a 10 hour tableting run for one batch. If FDA examines 5000 tablet hardness measurements across many batches of product, and finds one tablet was slightly harder than it should have been, the FDA “Observation” reads like this – “The company does not always assure that the products are manufactured according to the FDA approved process”. This is not FDA collusion. This is FDA harassment.
   3. The FDA found a bacteria in an Abbott (one of the largest branded drug companies in the world) baby formula manufacturing plant. There were about a dozen cases of infants becoming ill with this bacteria. FDA shut down the plant causing a major worldwide infant formula shortage four years ago. But the bacteria was never found in the pharmaceutical manufacturing equipment. Furthermore, that particular bacteria is found everywhere. Genetic testing showed that the bacteria in the Abbott plant was a different strain than what infected the infants. But FDA had already shut down the plant, caused a worldwide shortage crisis, and stuck to its absolute standards without regard to the consequences. Kol vochomer, if FDA does that to one of the most powerful branded drug companies in the world then imagine what FDA does to generic companies. I don’t need to wonder. I lived it.
   4. An FDA employee was revealed to have been bribed by a drug company. That was 1989. Does that justify an allegation in 2026 of collusion between FDA and drug companies?
5. The Ami Living article says that “…irresponsibility mutated into the criminal, with the generic drug executives knowing exactly what kind of defects lurked in their drugs and then shipping them anyway”.
   1. Using GPT 5.5, in the last five years there was one case of a generic drug manufacturer using an unapproved source of the active raw material, which is a big violation in FDA regulations, but there was no deficiency in the product.
   2. In 2013, the Indian generic drug manufacturer Ranbaxy knowingly shipped defective drugs to the US. But they were caught by FDA and severely (and deservingly) punished. There were $500MM in fines, products from their key facilities were banned from import into the US, and the company was sold when it was near bankruptcy. This is hardly collusion between the FDA and a generic drug company. So yes, executives from one company knowing did those things 13 years ago and that company was slaughtered by FDA.
6. The Ami Living article stated 17 paragraphs into the story that “I do want to note that multitudinous mishaps also occur in the brand-name domain…Mistakes happen, but they occur much more frequently in the generics industry…”
   1. This is a perfect example of a slanderous statement. 90% of US drugs are made by generic manufacturers so 90% of the mistakes should be in generics. The statement that more mistakes happen in generics is misleading in the extreme.
   2. The same paragraph then states “…a single bad lot doesn’t meant (sic) that all of a company’s products are toxic…”. Toxic means poisonous. I have never heard of a generic company’s tablets or capsules being toxic.
7. The Ami Living article states that, in FDA’s attempt to avoid shortages, “…substandard generics have been able to slip into our drug supply…”. This just isn’t true. FDA creates many shortages by halting or interfering with production when FDA believes that it is justified on quality grounds. When shortages occur, FDA allows compounding pharmacy companies to make the corresponding drug products. But these are NOT FDA approved drugs. They are NOT generics. And FDA has been severely cracking down on the quality standards of compounding pharmacy companies so that the leading regulatory expert, in the area of compounding pharmacies, stated that there is no longer profit to be made due to the FDA required manufacturing quality systems.
8. The Ami Living article states that, to avoid shortages, FDA has to just “hope and pray that the pallets of drugs unpacked at the ports are pristine enough to pass muster”. This is such a ridiculous statement that I almost don’t know how to respond. FDA doesn’t “hope and pray”. FDA takes samples, chemically tests them, and performs inspections of manufacturing plants demanding incredibly high levels of quality systems. This is just a slanderous statement in the cover story.
9. I need to skip pages of this fallacious article because the inaccuracies are too many to address right now. But I’ll leave you with one more laughable, ridiculous statement from this Ami Living article. It says that “An FDA inspection, one would assume, surely includes the testing of the drugs themselves on-site…Defying belief, this is actually beyond their (the FDA inspectors’) purview!”. I am almost speechless by this comment. Testing drug samples requires large, sophisticated scientific equipment that is found in chemistry laboratories. Usually these include dissolution apparatuses and HPLC-Mass Spec machines. HPLC-Mass Spec machines typically cost about $500k to $1.5MM, require a nitrogen generator or gas cylinder, dedicated electrical circuits, laboratory ventilation, and typical chemistry lab chemicals and devices. FDA inspectors collect samples and transport those samples back to the FDA District Offices to be analyzed by chemists in the FDA’s chemistry laboratories. Criticizing FDA inspectors for not testing the drug samples, during the inspection of the drug manufacturing plant, is beyond description.

Now I will provide you with the watered-down article that I provided to Ami Living but which was still too strong for them.

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You have been misled about generic drugs. I am an expert in the area. I will give you the full truth, good and bad. The bottom line is that generic drugs are considered overwhelmingly safe and effective to use in the US by the FDA.

Telling stories, about individuals’ situations, is called anecdotal evidence. It is not reliable evidence when widespread facts are available. First year medical students are taught that anecdotal stories are not evidence. Scientists never use anecdotal evidence. That is why scientific studies are done which, in the world of drugs, are called clinical trials.

You were told a story about a lung transplant patient dying, because GENERIC tacrolimus “… provided only half of the oxygen level she needed to survive”, which missed a few critical points. First, tacrolimus does not provide oxygen. It’s an anti-organ-rejection medicine. Secondly, doctors regularly measure blood levels of this critical drug in transplant patients to catch low levels before someone gets injured. Lastly, the anecdotal story says that the generic manufacturer had a recall of this drug but failed to tell you that the recall was for some half-strength capsules whereas the brand also had a recall for some capsules with no drug in them at all! Oops! So the generic had an error but the branded company had an even worse error.

So here’s the truth about generic drugs. Generic drugs are approved through human studies to show that they deliver the active drug into the bloodstream of human beings at the same rate as the corresponding branded products do. All FDA approved drugs are listed in FDA’s Orange Book and generic equivalents are given an “AB” rating by FDA. This allows pharmacies to substitute a generic drug for a branded drug prescription thereby saving citizens enormous amounts of money.

But that’s where the next phase begins. After FDA approval, the company now starts making batches of drugs that are released to the public. The FDA approval was given by tens of thousands of pages of scientific information sent to FDA headquarters in Silver Spring, Maryland to show that the generic is equivalent to the brand in people and the CMC section – Chemistry, Manufacturing, and Controls. This deals with the manufacturing machinery, procedures, chemistry testing, and assurance of quality.

But to oversee the actual manufacturing, that occurs for years thereafter, FDA has local offices of inspectors call District Offices around the country. These inspectors are frequently quite vicious in trying to write up violations. (I have documented FDA inspectors committing fraud in trying to shut down our company but that’s a story for a different time.)

In 2004, some of my Vice Presidents were telling me that Indian and Chinese tablet manufacturers were applying for FDA approvals to sell in the US. We would not be able to compete with companies that paid employees $25 per week and did not have to comply with labor or environmental laws. That’s when I started the process of transitioning our company into a drug discovery and drug delivery company.

The Indian companies started flooding the US with cheap generic tablets that we could not compete with. But I also realized that US companies live under the threat of criminal prosecution, if we would willingly violate FDA regulations, but the worst that the FDA could to do an Indian company was to prevent them from selling into the US. Additionally, we heard from FDA inspectors that they did not like going to India to do inspections. The travel, effort, and personal disruption was not desirable to them. We learned, through industry channels, that many Indian companies were cheating but there was nothing that we could do about it. It took years but eventually FDA at least partially caught up.

So how bad it is? Well, there are about 300 billion generic tablets and capsules sold in the US each year. If it is so terrible then where are the “bodies in the streets”? I don’t mean anecdotes. I mean where are the thousands of dying people that will register on the front pages of the news and in FDA’s surveillance systems? They don’t exist.

Recalls are part of the drug industry. The FDA is vicious in attacking US companies for quality. I have published videos on how the FDA caused a baby formula shortage, across the US, a few years ago based upon bacteria that were found at the Abbott (big branded company, not generic) baby formula manufacturing plant. However, genetic testing showed that the ANECDOTAL stories of babies getting sick from that bacteria were a different strain than what was in the plant but it was a strain that is found everywhere. Another example, for testing tablets for hardness, 100 tablets are typically tested for a 1 million tablet batch. Across many batches, if 5000 samples are tested and only one was accidentally missed as being a tiny bit too hard, then the FDA will write that “The company does not always assure that the product is manufactured according to the FDA approved process”. Vicious.

So here’s the truth:

1. Generic drugs are deemed by the FDA to be safe in the US.
2. If 90% of recalls occur in generics, and generics make 90% of the tablets, then that is to be expected.
3. Buying drugs from outside of FDA’s jurisdiction is dangerous because there is no way to know if you are getting the authentic pharmaceutical company manufactured drug or a counterfeit. We found one of our products being sold in Canada with our label on it but at a strength that we did not make.
4. Do not trust anecdotal (stories) evidence.
5. Do not be swayed by words like “massive” recalls when recalls are done by batch of product. So the recall of one batch could be 2 million tablets even though almost all such tablets are perfectly fine.
6. I can afford branded products. I take generics.

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Now, here are my credentials.

Dr. Richard (Kasriel) H. Roberts is a Medical Doctor and Doctor of Biophysics, educated at the University of Pennsylvania under the Medical Scientist Training Program scholarship from the National Institutes of Health and trained in Internal Medicine at Harvard. He was the President and CEO of a drug company for 24 years, URLPharma. Dr. Roberts lives in Lakewood, is active in helping and defending the frum community, and has no financial interests in the drug industry anymore beyond owning the S&P 500 index.