A Generic Drug Scandal That SHOCKED Even Us!

When it comes to generic drugs I am not easily shocked, but 3 stories from ProPublica this week have me even more alarmed than usual. I have been writing about generic drugs for more than 50 years. In the 1970s, inexpensive knock-off medications were mostly made in the US. I was a big advocate of these alternatives to pricier brand name medicines. That all started to change in the late 1990s when a nurse alerted us to problems she observed with the generic anticoagulant warfarin (Coumadin). By 2000 we began to suspect a generic drug scandal was brewing at the FDA. We started investigating the FDA’s ability to guarantee generic drug quality. What we discovered was distressing. This week, ProPublica verified what we have suspected for the last two decades. The FDA is not protecting the American public when it comes to generic drug quality.

Why Generic Drug Quality Matters!

The chances are very good that if you are taking any medicine at all, you are taking a generic formulation. That’s because generic drugs now make up more than 90% of the medications dispensed in American pharmacies. We have included one of the ProPublica stories on our website in this week’s Health Headlines at this link.

“Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs”

It is a shocking tale of woe and intrigue.

The ProPublica team also released this article:

“We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market”

We were gratified to read the last paragraph of this article:

“Journalists have been uncovering problems with generic drugs for years. Katherine Eban’s bestselling 2019 book, “Bottle of Lies,”exposed how Indian drugmakers failed to follow basic quality and safety standards and often knowingly sent shoddy drugs abroad. In 2023, a Bloomberg investigation revealed, among other things, how poisoned cough syrup made in India spread around the world. And the independent watchdog The People’s Pharmacy has raised repeated concerns about the quality of some generic drugs.”

Katherine Eban’s book, Bottle of Lies, is all about the generic drug scandal we alerted her to many years ago. Here is a link to our interview with Katherine.

“Show 1169: What Are the Problems with Generic Drugs?”

A Shocking Revelation About FDA’s Lack of Transparency:

You will shortly read about my outrage that the FDA seemed more concerned about protecting the generic drug industry than the American public. It is gratifying but disheartening to read ProPublica’s 3rd article (June 18, 2025) titled:

“ProPublica Sued the FDA for Withholding Records About the Safety of Generic Drugs”

“The agency declined to quickly release documents that would identify drugs made at some of the most troubled foreign factories. The request was part of ProPublica’s ongoing investigation into the safety of America’s generic drug supply.”

Here’s the gist of the article about an unforgivable generic drug scandal(s):

• “Americans (including pharmacists, doctors, hospital systems, policy makers) cannot see for themselves which drugs may have been made in unsafe facilities”
• FDA allowed foreign drug companies that were in violation of quality standards to continue to export drugs into the US market
• “More than 150 drugs or their ingredients were given these little-known exemptions over the past dozen years.”

We have repeatedly asked why we cannot learn about suspect drugs so we can warn US citizens to avoid such products. The FDA will not make this information available. Why not? Who is the agency protecting?

The Generic Drug Scandal Most MDs Are Unaware of:

How Does the FDA Approve Generic Drugs?

Ask most doctors, nurses, pharmacists or hospital administrators how generic drugs make it to market and you are likely to get a blank stare. Push a little harder and about the best you will get is something like this:

“the Food and Drug Administration approves them and the FDA must know what it’s doing.”

It’s way more complicated than that! As far as the idea that “the FDA knows what it’s doing,” I am not so sure. A recent drug scandal involved generic Viagra, generic Cialis and potentially hundreds of other medications. Anna Edney for Blomberg (July 9, 2024), revealed another generic drug mess.

First, the brand name drug companies do not have to reveal anything about their process for making the original formulation. The information is “proprietary.” And the FDA does not share such information with generic manufacturers.

Reverse Engineering:

The Cambridge Dictionary defines “reverse engineering” this way:

“the act of copying the product of another company by looking carefully at how it is made”

The Britannica Dictionary defines “reverse engineer” as:

“to study the parts of (something) to see how it was made and how it works so that you can make something that is like it”

During World War II both the Americans and Brits discovered that the Germans had created a very efficient gasoline can that did not leak. The allies reverse engineered the design and created “Jerry cans.”

These days there is all kinds of reverse-engineered software. This is also the process whereby generic drug companies attempt to mimic a brand name medicine and sell it for a lot less.

Reverse-Engineering Generic Drugs:

The problem is that recreating a brand name medicine from scratch is tricky business. Not only do you have to recreate the active pharmaceutical ingredient (API) but you have to add excipients (binders, fillers, colors, etc). Then the generic drug company has to put it all together so that the generic drug mimics the brand in the way it releases the API into the blood stream.

In the extraordinary book, Bottle of Lies, Katherine Eban details the process of reverse engineering and describes huge generic drug scandals.  The Indian drug company Ranbaxy was trying to duplicate the prescription acne drug called Accutane. You can read the details of this generic drug scandal at this link. It’s worth a minute of your time!

The FDA Brags About Generic Drug Savings:

Generic drugs are big business. Over 90 percent of the medications that are dispensed in pharmacies are now generic.

According to the FDA, these low-cost knockoffs of brand name medicines “saved the U.S. health care system $2.2 trillion from 2009 to 2019.” That is a lot of money by any standard.

How good are these copycat pharmaceuticals? That is a question we have been asking for decades. To this day, we do not have a good answer.

The Food and Drug Administration maintains that:

“FDA-approved generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterparts.”

The agency asserts that:

“The FDA Generic Drugs Program conducts a rigorous pre-approval review to make sure generic medicines meet these requirements.”

Is the FDA’s Trust in Testing Companies Warranted?

The problem is that the generic drug supply chain has a large number of links. Some of those links are surprisingly weak.

An early step in the FDA’s approval process requires that a generic drug company test its new formulation against the brand name it is trying to emulate. Most pharmaceutical manufacturers hire third party organizations to carry out these tests on human volunteers.

The companies that manage such clinical trials are usually called CROs (contract research organizations). What that means is that the CRO arranges for several dozen human subjects to come into a clinical laboratory facility. Half will get the brand name and half will get the generic knock off.

In theory, neither the subjects (who get paid) nor the investigators who conduct the study know who gets what. Typically, blood samples are taken hourly (or sometimes more frequently) over the course of a day. In theory, the generic medicine is supposed to parallel the brand name so closely that there is no clinical difference.

The generic drug company then submits the data to the FDA. If the bioequivalence drug curves are good enough, the FDA usually approves the lower-cost formulation.

Sadly, though, the agency does not make the data public so generic drug buyers or health care professionals can review it for themselves. The data are considered proprietary and therefore confidential.

The FDA has to rely upon the integrity of the CRO and the generic drug manufacturer to submit accurate data. That is not always the case.

When the Bioequivalence Data Are NOT Trustworthy:

The FDA has long reassured physicians, pharmacists and patients that generic drugs are every bit as good as their brand name counterparts. But no one is actually allowed to see the data. Are the results the FDA relies on reliable?

A Generic Drug Scandal Is Revealed:

The data generated by these contractors are absolutely critical for regulatory approval. Sometimes, though, the generic drug doesn’t perform as predicted.

Over a decade ago, the FDA missed problems at a Houston CRO called Cetero. But a whistle blower at the lab alleged that the company had manipulated data. The FDA eventually discovered that a lot of the drug data that had been submitted were fraudulent. You can read about “The Big Ooops” scandal at this link.

Later, the European Medicines Agency (EMA) recommended that more than a hundred generic drugs be pulled off the market.

According to the EMA:

“EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organization (CRO) located in Ahmedabad, India.

“The recommendation comes after irregularities were found in how the CRO carried out bioequivalence studies, which raised serious concerns about the company’s quality management system and the reliability of data from that site. Bioequivalence studies are conducted to show that a generic medicine releases the same amount of active substance in the body as the reference medicine.

“The CHMP looked at all medicines tested by Synchron Research Services on behalf of EU companies and found that for the majority (around 100 medicines) no adequate bioequivalence data were available from other sources. The Committee recommended that these medicines be suspended.”

Perhaps you noted that the bioequivalence data generated by Synchron Research Services in Ahmedabad, India, was under suspicion. The most fundamental step in approving a copycat drug, the blood testing comparison between the brand and the generic, was questionable for around 100 medications.

The FDA and the Generic Drug Scandal!

European regulators are not the only ones who have found data that may be unreliable. In the fall of 2021, the FDA cited “a substantial data integrity problem” at two CROs (Pink Sheet, Oct. 11, 2021). One was Synchron, while the other was Panexcell Clinical Lab, located in Navi Mumbai, India.

According to Pink Sheet reporter Derrick Gingery,

“…the FDA determined after an extensive investigation that all study data from both firms should be rejected.”

The Pink Sheet is a pharmaceutical industry insider publication.

It states:

“A list of the concerned medicines has been published by the EMA, including products from leading generics players such as Accord, Jubilant, Lupin, Sandoz, Stada, Strides, Teva, Viatris and Zentiva.”

Fast Forward to June, 2024 and Synapse Labs:

On June 18, 2024 the FDA notified drug companies:

“…that clinical and bioanalytical studies conducted by Synapse Labs Pvt. Ltd. (Synapse)—a contract research organization (CRO) based in Pune, India—are not acceptable because of data integrity concerns. Studies conducted by Synapse must be repeated.

“During analyses of study data generated at Synapse and submitted in several applications, FDA identified significant unexplained anomalies in the data that indicate the data were falsified.”

The Bloomberg Big Reveal!

On July 9, 2024 Anna Edney of Bloomberg wrote about the faked data:

“Generic versions of erectile dysfunction drugs Viagra and Cialis, among other medications, were allowed on the US market using potentially problematic data that call into question their safety and efficacy, a Bloomberg analysis found.”

Ms. Edney went on to note that the data from Synapse Labs:

“…may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans’ medicine cabinets.”

“The FDA isn’t telling patients, doctors or pharmacists which drugs among thousands might be impacted because the agency said whether a drugmaker used a particular research company for hire is ‘confidential information,’ according to the FDA alert.”

How Did the FDA React to Such Generic Drug Scandals?

One might imagine that the FDA would follow the example of European regulators and act to get the relevant drugs off the market. The EMA also provided a list of all the affected drugs.

Back in September 2021 the FDA announced:

“FDA is changing the therapeutic equivalence rating to ‘BX’ for any approved ANDA [abbreviated new drug application] that relied on data from Synchron or Panexcell. A ‘BX’ rating indicates data reviewed by the agency are insufficient to determine therapeutic equivalence (substitutability) of the generic product to its brand name product. A drug with a ‘BX’ rating is still approved and can be prescribed but is not recommended as automatically substitutable at the pharmacy (or by a pharmacist) for the brand-name drug.”

What The Heck? BX or BS?

This issue may seem too technical to be of much interest to ordinary people. What it means in practice, though, is that the FDA is not banning any of the questionable drugs from the American marketplace. Instead, busy pharmacists have to figure out which generic drugs are not considered reliable.

It would be as if the FAA (Federal Aviation Administration) learned that the quality testing data for brakes on a jumbo jet made by company XYZ were unreliable and potentially fraudulent. Instead of banning those brakes and grounding the planes, though, the FAA left the decision to use the brakes entirely up to the company. That would be a huge scandal if it got out.

The American public would not want to fly on an airplane that did not have reliable safety data for its brakes. But the public would not be allowed to learn which airplanes were continuing to use bad brakes.

The FDA seems to be saying, Don’t Worry, Be Happy! So what if the Europeans are recalling/banning generic drugs that were approved based on fraudulent data? Here in the United States those drugs will stay on the market. We are leaving it up to pharmacists to decide whether to buy them and dispense them. We will just call those drugs “BX.” Some might call this idea BS.

In the scandal regarding falsified CRO data from India, the FDA did not release information on the drugs in question. We suspect that the agency will cite confidentiality, even though European regulators have released a list of potentially problematic medications.

The Generic Drug Scandal Goes Way Back!

This is not the first time the FDA has learned that the critical bioequivalence testing process may have failed. Hundreds of generic drug products have likely been approved based on questionable data. Companies that have been under scrutiny in addition to Synapse labs, Synchron and Panexcell include GVK Biosciences, Semler and Micro Therapeutic Research Labs.

It has even happened in the U.S. As mentioned above, we document the crazy case of Cetero Research in Houston, Texas at this link. We encourage you to read our article, but here is a quick summary of this generic drug scandal:

There were three takeaways:

1) The FDA did not discover the fraud on its own
2) The FDA never told the American public which drugs were affected
3) The FDA never recalled or banned the drugs in question

We suspect that many, if not all, remain on the market to this day!

What to Make of These Generic Drug Scandals

What does all this mean for you? Can you trust your generic medicine?

The Europeans provide a complete list of products and manufacturers that are under suspicion. Because the FDA is not as transparent about such drugs, neither physicians nor patients have an easy way to evaluate the quality of their generic medicine.

Ask your doctor and your pharmacist if they have ever heard of a “BX” rating! We will bet you that most will have no idea what you are talking about.

Here, again, is the FDA double-talk that makes no sense to us:

“A “BX” rating indicates data reviewed by the agency are insufficient to determine therapeutic equivalence (substitutability) of the generic product to its brand name product. A drug with a “BX” rating is still approved and can be prescribed but is not recommended as automatically substitutable at the pharmacy (or by a pharmacist) for the brand-name drug.”

We think this seems a lot like Alice in Wonderland. What do you think? Please share your thoughts in the comment section below.

The CRO scandals are only the first link in the generic drug chain. Manufacturing problems and shipping concerns could also have an impact on the quality of many generic medicines. Until the FDA tests such products before they are sold to consumers, we have no way of knowing whether they live up to expectations.

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